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The Fund normally invests at least 80 percent of its total assets in securities that comprise the Funds benchmark index. The Biotech Index includes common stocks and depositary receipts of U.S. exchange-listed companies in the biotechnology industry. Such companies may include medium-capitalization companies and foreign companies that are listed on a U.S. exchange. To be initially eligible for the Biotech Index, companies must generate at least 50 percent of their revenues from biotechnology. Biotechnology includes companies engaged primarily in research (including research contractors) and development as well as production, marketing and sales of drugs based on genetic analysis and diagnostic equipment (excluding pharmacies). Of the largest 50 stocks in the biotechnology industry by full market capitalization, the top 25 by free-float market capitalization (i.e., includes only shares that are readily available for trading in the market) and three-month average daily trading volume are included in the Biotech Index.

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	U.S. Attorney General Merrick Garland said that the Justice Department would file an appeal with the U.S. Supreme Court seeking to block the entirety of Kacsmaryk&#39;s order suspending the FDA approval of the abortion pill mifepristone. 


Mifepristone Abortion Pill Access in Limbo: Justice Department May Ask Supreme Court&#39;s Intervention

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	A U.S. federal appeals court has temporarily blocked a decision by a Texas judge to halt the FDA&#39;s approval of a widely used abortion drug.


Women&#39;s Reproductive Rights: US Court Preserves Access To Abortion Pill For Now, But With Tighter Rules

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	New York and California are stockpiling an alternative abortion medication in case a Texas judge&#39;s order suspending the FDA approval of the primary drug, mifepristone, goes into effect later this week.


New York and California Prepare For Potential Mifepristone Ban In Texas With Stockpiling Of Alternative Abortion Medications

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	In a new court filing, the Democratic attorneys general for 23 U.S. states have reportedly warned that a federal judge&#39;s decision to suspend the FDA&#39;s approval of mifepristone &#34;presents devastating risks to millions of people,&#34; including those in states where abortion remains legal.


Attorney Generals of Over 20 States Sound Alarm Over Suspension Of Abortion Med Approval: &#34;Devastating Risks&#34; Ahead

FDA Withdraws Lone Premature Birth Drug Makena Over Lack of Proven Benefits

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	U.S. District Judge Matthew Kacsmaryk questioned President Joe Biden&#39;s administration lawyers on whether the federal regulatory approval of the abortion pill mifepristone was proper.
	The judge is reportedly considering a request by anti-abortion groups to ban sales of the drug nationwide.


US Judge Weighs Nationwide Ban On Abortion Pills

FDA Takes Action To Restrict Unlawful Import Of Animal Tranquilizer &#39;Tranq&#39; Or &#39;&#39;Zombie Drug&#39;

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For the first time in 18 years, there was a new treatment for Alzheimer’s Disease approved by the FDA.

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Moderna Inc. (NASDAQ: MRNA) shares gapped down Thursday and have since gained back some ground.

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The biotechnology space is always fertile territory for mergers and acquisitions, and that theme was on display over the weekend when AstraZeneca (NYSE: AZN) announced a

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<ul>
<li>U.S. Attorney General Merrick Garland said that the Justice Department would file an appeal with the U.S. Supreme Court seeking to block the entirety of Kacsmaryk&#39;s order suspending the FDA approval of the abortion pill mifepristone.&nbsp;</li>
<li>Garland said the administration &quot;will be seeking emergency relief from the Supreme Court to defend the FDA&#39;s scientific judgment and protect Americans&#39; access to safe and effective reproductive care.&quot;</li>
<li>The New Orleans-based 5th U.S. Circuit Court of Appeals put on hold part of last Friday&#39;s order by U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas, while he hears a lawsuit by anti-abortion groups seeking to ban it.</li>
<li>The Planned Parenthood Federation of America condemned the 5th Circuit&#39;s decision as a rejection of science and law.</li>
<li>&quot;The federal judiciary has &mdash; for the second time this week &mdash; rejected science and the law, and this time, the court decided they had the authority to re-write mifepristone&#39;s label,&quot; CNBC&nbsp;<a class="editor-rtfLink" href="https://www.cnbc.com/2023/04/13/abortion-pill-mifepristone-court-keeps-it-on-market-blocks-mail-delivery.html" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">reported</a>&nbsp;citing Alexis McGill Johnson, president of Planned Parenthood.&nbsp;</li>
<li>&quot;If allowed to stand, the consequences of this decision will be catastrophic not just for medication abortion access but the entire drug approval system,&quot; he added.</li>
<li>A U.S. federal appeals court has&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/04/31784287/womens-reproductive-rights-us-court-preserves-access-to-abortion-pill-for-now-but-with-tighter-ru" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">temporarily blocked</a>&nbsp;a decision by a Texas judge.&nbsp;</li>
<li>The abortion pill mifepristone will remain available in the U.S. for now but with some restrictions, including requiring in-person doctor visits to obtain the drug and limiting its use to the first seven weeks of pregnancy from the current ten, a federal appeals court ruled.</li>
</ul>

Mifepristone Abortion Pill Access in Limbo: Justice Department May Ask Supreme Court's Intervention

<ul>
<li>A U.S. federal appeals court has temporarily blocked a decision by a Texas judge to halt the FDA&#39;s approval of a widely used abortion drug.</li>
<li>The abortion pill mifepristone will remain available in the U.S. for now but with some restrictions, including requiring in-person doctor visits to obtain the drug and limiting its use to the first seven weeks of pregnancy from the current ten, a federal appeals court ruled.</li>
<li>Related Content:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/04/31766180/new-york-and-california-prepare-for-potential-mifepristone-ban-in-texas-with-stockpiling-of-alter" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">New York and California Prepare For Potential Mifepristone Ban In Texas With Stockpiling Of Alternative Abortion Medications</a>.</li>
<li>In his last week ruling, Texas Judge Matthew Kacsmaryk ordered pulling mifepristone from the market in seven days, saying the FDA had violated federal rules that allowed for the accelerated approval of some drugs.&nbsp;</li>
<li>The order was set to take effect on Friday.</li>
<li>The Biden administration, the anti-abortion groups, or both could also seek to appeal immediately to the U.S. Supreme Court,&nbsp;<a class="editor-rtfLink" href="https://www.reuters.com/legal/us-appeals-court-preserves-limited-approval-abortion-pill-2023-04-13/" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">Reuters</a>&nbsp;reported.</li>
<li>Wednesday&#39;s ruling came from a panel of three 5th Circuit judges, two appointed by then-President Donald Trump and one by George W. Bush, both Republicans, Reuters added.</li>
<li>Judge Catharina Haynes, the Bush appointee, partly dissented, saying she would have temporarily blocked Kacsmaryk&#39;s order entirely.</li>
<li>The emergency stay is meant to remain in place until the 5th Circuit can hear the Biden administration&#39;s appeal of Kacsmaryk&#39;s order more fully.&nbsp;</li>
<li>It was first approved for the termination of pregnancy up until seven weeks gestation.</li>
<li>The 2016 changes, among other things, reduced the number of in-person visits that patients must make from three to one and allowed the pills to be prescribed to women at up to 10 weeks gestation instead of up to seven weeks.</li>
<li>Photo via Wikimedia Commons</li>
</ul>

Women's Reproductive Rights: US Court Preserves Access To Abortion Pill For Now, But With Tighter Rules

<ul>
<li>New York and California are stockpiling an alternative abortion medication in case a Texas judge&#39;s order suspending the FDA approval of the primary drug, mifepristone, goes into effect later this week.</li>
<li>The alternative option, misoprostol, is FDA-approved to treat gastric ulcers,&nbsp;<a class="editor-rtfLink" href="https://www.cnbc.com/2023/04/11/abortion-pill-ruling-new-york-california-stockpile-misoprostol.html" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">noted</a>&nbsp;CNBC. But the use of misoprostol alone to induce abortions is endorsed by the World Health Organization and is used in countries where mifepristone is unavailable.</li>
<li>Also Read:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/04/31752497/attorney-generals-of-over-20-states-sound-alarm-over-suspension-of-abortion-med-approval-devastat" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">Attorney Generals of Over 20 States Sound Alarm Over Suspension Of Abortion Med Approval: &quot;Devastating Risks&quot; Ahead</a>.</li>
<li>It will remain on the market if U.S. District Judge Matthew Kacsmaryk&#39;s order suspending mifepristone takes effect this week Saturday.</li>
<li>More than half of abortions in the U.S. use a combination of mifepristone and misoprostol.</li>
<li>Some U.S. abortion providers are prepared to offer misoprostol as a stand-alone treatment, CNBC&nbsp;<a class="editor-rtfLink" href="https://www.cnbc.com/2023/04/11/alternative-abortion-pill-could-be-used-if-the-mifepristone-ban-is-upheld.html" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">reported</a>&nbsp;citing Jenny Ma, senior staff attorney at the Center for Reproductive Rights, a legal advocacy group representing abortion providers worldwide. Ma also said that other providers might not be ready to switch to a misoprostol-only regimen.</li>
<li>New York Gov. Kathy Hochul ordered the state health department to purchase 150,000 doses of misoprostol, a five-year pill supply. Hochul&#39;s announcement comes a day after Gov. Gavin Newsom said California has secured 2 million misoprostol pills.</li>
<li>Hochul said she is working with New York&#39;s legislature to require private insurers to cover misoprostol when prescribed off-label for abortions.</li>
<li>The Justice Department and Danco Laboratories, the distributor of mifepristone, have asked the U.S. 5th Circuit Court of Appeals to block Kacsmaryk&#39;s ruling by noon Thursday.</li>
<li>Photo via Wikimedia Commons</li>
</ul>

<ul>
<li>In a new court filing, the Democratic attorneys general for 23 U.S. states have reportedly warned that a federal judge&#39;s decision to suspend the FDA&#39;s approval of mifepristone &quot;presents devastating risks to millions of people,&quot; including those in states where abortion remains legal.</li>
<li>The attorneys general, in their filing, called on the U.S. 5th Circuit Court of Appeals to keep mifepristone on the market.</li>
<li>Last week Friday, a U.S. judge suspended the FDA&#39;s approval of mifepristone, an abortion pill to&nbsp;<a class="editor-rtfLink" href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">terminate</a>&nbsp;a pregnancy through ten weeks gestation.</li>
<li>But he put his decision on hold for one week to give the Biden administration time to appeal.</li>
<li>Also Read -&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/04/31739346/drugmakers-stand-up-for-reproductive-rights-pfizer-and-biogen-among-300-condemning-abortion-pill-" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">Drugmakers Stand Up for Reproductive Rights: Pfizer and Biogen Among 300 Condemning Abortion Pill Approval Suspension</a>.</li>
<li>Kacsmaryk&#39;s ruling will take effect at 12 a.m. CT on Saturday if the 5th Circuit does not halt it.</li>
<li>Citing the filing, CNBC&nbsp;<a class="editor-rtfLink" href="https://www.cnbc.com/2023/04/11/abortion-texas-mifepristone-ruling-order-threatens-access.html" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">reported</a>&nbsp;that attorneys general and the District of Columbia condemned Kacsmaryk&#39;s ruling as &quot;legally erroneous&quot; and warned it would undermine the FDA&#39;s approval process.</li>
<li>The attorneys general argued that Kacsmaryk&#39;s order would &quot;eviscerate the sovereign decisions&quot; made by the states to protect access to abortion when last year, the Supreme Court&#39;s decision overturned Roe v. Wade, which said there was a federal constitutional right to abortion.</li>
<li>Kacsmaryk&#39;s decision does not affect the availability of misoprostol, which the World Health Organization recommends as a standalone abortion drug.</li>
<li>States such as California are stockpiling misoprostol if Kacsmaryk&#39;s decision goes into effect.</li>
<li>Photo via Wikimedia Commons</li>
</ul>

Attorney Generals of Over 20 States Sound Alarm Over Suspension Of Abortion Med Approval: "Devastating Risks" Ahead

<ul>
<li>Today, the FDA announced the&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/23/04/n31699749/fda-commissioner-and-chief-scientist-announce-decision-to-withdraw-approval-of-makena" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">final decision to withdraw</a>&nbsp;approval of Privately held-Covis Pharma&#39;s&nbsp;Makena (hydroxyprogesterone caproate injection), a drug approved under the accelerated approval pathway to reduce the risk of preterm birth.&nbsp;</li>
<li>The decision was issued jointly by the FDA Commissioner and Chief Scientist.&nbsp;</li>
<li>Effective today, Makena and its generics are no longer approved and cannot lawfully be distributed.</li>
<li>The FDA approved Makena under the accelerated approval pathway in 2011 based on a determination that the sponsor had demonstrated a drug effect on an intermediate clinical endpoint that was reasonably likely to predict clinical benefit.&nbsp;</li>
<li>The agency&#39;s approval required the sponsor to conduct a post-marketing confirmatory study.&nbsp;</li>
<li>The confirmatory study did not verify clinical benefit, and the FDA&#39;s Center for Drug Evaluation and Research (CDER) proposed withdrawing the drug&#39;s approval in 2020.&nbsp;</li>
<li>The sponsor requested a hearing, which was held in&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/03/31252820/covis-pharma-to-withdraw-only-fda-approved-treatment-to-prevent-preterm-births" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">October 2022</a>.</li>
<li>In October, the FDA&#39;s Obstetrics, Reproductive and Urologic Drugs Advisory Committee voted that Makena should not remain on the market after a large&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/22/10/29337799/citing-ineffectiveness-fda-panel-recommends-taking-down-famed-preterm-birth-drug-from-market" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">study failed to show that it was effective</a>.&nbsp;</li>
<li>Wall Street Journal&nbsp;<a class="editor-rtfLink" href="https://www.wsj.com/articles/fda-forces-the-only-drug-for-preterm-births-to-leave-market-a0e92b24?mod=latest_headlines" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">writes</a>&nbsp;that Makena has possible side effects, including blood clots, depression, and allergic reactions.&nbsp;</li>
<li>Covis said previously that the drug has a strong safety record and that adverse events are rare, but the FDA has said some evidence suggests there may be long-term risks that aren&#39;t yet well understood.</li>
</ul>

<ul>
<li>U.S. District Judge Matthew Kacsmaryk questioned President Joe Biden&#39;s administration lawyers on whether the federal regulatory approval of the abortion pill mifepristone was proper.</li>
<li>The judge is reportedly considering a request by anti-abortion groups to ban sales of the drug nationwide.</li>
<li>The judge raised the possibility of keeping the drug on the market but re-imposing some restrictions lifted by Biden&#39;s administration, including requiring it to be dispensed in person rather than by mail.&nbsp;</li>
<li>Kacsmaryk said he would rule &quot;as soon as possible.&quot;</li>
<li>Related:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/government/23/03/31297156/new-york-governor-attorney-general-ask-three-pharmacy-operators-commitment-over-abortion-drug-access" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">New York Governor, Attorney General Ask Three Pharmacy Operators&#39; Commitment Over Abortion Drug Access</a>.</li>
<li>The anti-abortion groups sued the FDA in November, accusing the agency followed an improper process to approve mifepristone in 2000. It did not adequately consider the drug&#39;s safety when used by girls under 18.</li>
<li>The plaintiffs are asking Kacsmaryk for a preliminary order halting sales of mifepristone nationwide - even in states where abortion is legal - while their lawsuit proceeds.</li>
<li>Lawyers for the U.S. Justice Department and an attorney for mifepristone&#39;s manufacturer, Danco Laboratories, argued that the plaintiffs had no standing and that mifepristone has an impressive safety and efficacy record,&nbsp;<a class="editor-rtfLink" href="https://www.reuters.com/legal/texas-judge-consider-banning-abortion-pill-us-2023-03-15/" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">Reuters</a>&nbsp;reported.</li>
<li>Major medical organizations have weighed in on the side of the FDA, saying mifepristone &quot;has been thoroughly studied and is conclusively safe.&quot;</li>
<li>Photo via Wikimedia Commons</li>
</ul>

<ul>
<li>The&nbsp;<a class="editor-rtfLink" href="https://www.fda.gov/news-events/press-announcements/fda-takes-action-restrict-unlawful-import-xylazine" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">FDA issued</a>&nbsp;an &quot;import alert&quot; about the animal tranquilizer xylazine, also called &quot;tranq,&quot; &quot;tranq dope,&quot; and &quot;zombie drug.&quot;&nbsp;</li>
<li>The notice allows agents to seize shipments of xylazine and &quot;unapproved finished drug products&quot; containing it without physically examining the shipments.&nbsp;</li>
<li>The FDA said it will scrutinize incoming xylazine shipments to ensure they are &quot;properly labeled, not adulterated, and for legitimate veterinary use.&quot;&nbsp;</li>
<li>Xylazine, a tranquilizer used on large animals, is not approved for human consumption in the U.S., but so far, tranq dope has reportedly spread to at least 39 states, Washington D.C., and Puerto Rico.&nbsp;</li>
<li>Xylazine can depress breathing, blood pressure, heart rate, and body temperature to critical levels.&nbsp;</li>
<li>Additionally, people who inject drugs containing xylazine can develop severe skin wounds and patches of dead and rotting tissue that easily become infected.</li>
<li>These wounds can develop in areas of the body away from the injection site.</li>
<li>The chemical xylazine has increasingly been found in illicit drugs such as illicitly manufactured fentanyl and other drugs and has increasingly been detected in overdose deaths.</li>
<li>Xylazine is not an opioid, and it&#39;s often mixed with other drugs.</li>
<li>It has been identified as a contaminant found in combination with opioids such as illicit fentanyl and other illicit products that contain stimulants such as methamphetamine and cocaine.&nbsp;</li>
<li>Xylazine is typically sold as a liquid when used for veterinary purposes.&nbsp;</li>
<li>However, according to some reports, several online vendors sell powder forms of xylazine. One China-based seller reportedly said xylazine had become a &quot;hot&quot; product among Americans in 2021.</li>
<li>An October Drug Enforcement Administration&nbsp;<a class="editor-rtfLink" href="https://www.dea.gov/sites/default/files/2022-12/The%20Growing%20Threat%20of%20Xylazine%20and%20its%20Mixture%20with%20Illicit%20Drugs.pdf" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">report</a>&nbsp;found that a kilogram of xylazine powder can be bought from Chinese suppliers from $6-$20 per kilogram.&nbsp;</li>
<li>People who use illicit drugs may not be aware of the presence of xylazine.</li>
<li>Photo by Diamond Rehab Thailand via Pixaby</li>
</ul>

FDA Takes Action To Restrict Unlawful Import Of Animal Tranquilizer 'Tranq' Or ''Zombie Drug'

For the first time in 18 years, there was a new treatment for Alzheimer&rsquo;s Disease approved by the FDA.
Aducanumab from Biogen Inc (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/biib#NASDAQ">BIIB</a>) was <a href="https://www.benzinga.com/general/biotech/21/06/21455132/biogen-gets-fda-nod-for-controversial-alzheimers-drug-first-treatment-approval-for-the-disease-in">approved </a>as a drug that can reduce the clinical decline of dementia. The FDA concluded using Aduhelm (the marketing name of Aducanumab) for Alzheimer&rsquo;s patients outweighs the risk of therapy.
The result saw Biogen shares halted for hours Monday before reopening for trade at $449, significantly above the 52-week high of $363.92. Investors sent shares of ETFs with Biogen up higher prior to shares of Biogen resuming trade.
Here is a look at five ETFs with large exposure to Biogen shares (data as of June 4 from <a href="https://etfdb.com/stock/BIIB/">ETFdb.com</a> and the company&rsquo;s websites).
Invesco Dynamic Biotechnology &amp; Genome ETF (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/pbe#NYSE">PBE</a>): +5.1%
The <a href="https://www.invesco.com/us/financial-products/etfs/product-detail?audienceType=Investor&amp;ticker=PBE">Invesco Dynamic Biotechnology &amp; Genome ETF</a> follows the Dynamic Biotech &amp; Genome index, investing at least 90% of assets in securities found in the index. The index includes 30 companies in the sector. The ETF rebalances quarterly in February, May, August and November.
Biogen is the second largest weighted stock in the PBE ETF at 5.23% of assets. Eight of the 31 holdings in the ETF have a weighting of 4.8% or more including Illumina Inc (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ilmn#NASDAQ">ILMN</a>), Gilead Sciences (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gild#NASDAQ">GILD</a>), Bio-Techne (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tech#NASDAQ">TECH</a>), Alexion Pharmaceuticals (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/alxn#NASDAQ">ALXN</a>), Amgen Inc (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/amgn#NASDAQ">AMGN</a>), Catalent Inc (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/ctlt#NYSE">CTLT</a>) and Qiagen (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/qgen#NYSE">QGEN</a>).
VanEck Vectors Biotech ETF: (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bbh#NASDAQ">BBH</a>): +4.6%
The VanEck Vectors Biotech ETF <a href="https://www.vaneck.com/us/en/investments/biotech-etf-bbh/">follows</a> the MVIS Us Listed Biotech 25 Index, which tracks the performance of companies involved in genetic analysis and diagnostics equipment.
Biogen is the eighth largest holding in the ETF at 4.8% of assets. The ETF&rsquo;s top holdings are Amgen, Moderna Inc (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrna#NASDAQ">MRNA</a>) and BioNTech (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bntx#NASDAQ">BNTX</a>) at 9%, 7.2% and 5.8% of assets respectively.
Related Link: <a href="https://www.benzinga.com/analyst-ratings/21/05/21178928/where-biogen-stands-with-analysts">Where Biogen Stands With Analysts</a>
Invesco BuyBack Achievers ETF (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/pkw#NASDAQ">PKW</a>): +2%
Along with several biotechnology sector ETFs, the<a href="https://www.invesco.com/us/financial-products/etfs/product-detail?audienceType=Investor&amp;ticker=PKW"> Invesco BuyBack Achievers ETF</a> was up on news from Biogen&rsquo;s approval. The ETF, which has 109 holdings, is based on the Nasdaq US BuyBack Achievers Index. The Index tracks companies that have a net reduction in shares outstanding of 5% or more over the last trailing twelve months. The ETF is rebalanced quarterly in January, April, July and October.
Biogen is the fifth largest holding in the ETF at 3.5% of assets and the top held health care stock in the fund. Top holdings in the ETF include Oracle Corp (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/orcl#NYSE">ORCL</a>), Charter Communications (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/chtr#NASDAQ">CHTR</a>), eBay Inc (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ebay#NASDAQ">EBAY</a>) and Allstate Corp (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/all#NYSE">ALL</a>).
First Trust NYSE Arca Biotechnology Index Fund (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/fbt#NYSE">FBT</a>): +4.3%
The First Trust NYSE Arca Biotechnology Index Fund <a href="https://www.ftportfolios.com/Retail/etf/etfsummary.aspx?Ticker=FBT">tracks </a>an index of 30 holdings that cover several areas of the sector. The ETF has 30 holdings and due to the equal weighting the top 10 holdings represent 3.5% to 4.0% of assets.
Biogen is the eighth largest holdings at 3.5% of assets. The fund rebalances in January, April, July and October to get components to equal weighting.
iShares Nasdaq Biotechnology ETF (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ibb#NASDAQ">IBB</a>): +4.4%
With $10.1 billion assets under management, the<a href="https://www.ishares.com/us/products/239699/ishares-nasdaq-biotechnology-etf"> iShares Nasdaq Biotechnology ETF</a> is one of the largest in the sector and could have a great impact from the Biogen news. The ETF has 277 holdings and tracks an index that covers companies listed on the Nasdaq in both the biotechnology and pharmaceutical fields.
Biogen represents 3.5% of assets and is the seventh largest holding. Top holdings in the ETF are Amgen, Gilead and Moderna at weightings of 8.7%, 7.1% and 6.9%, respectively.
Price Action: Shares of Biogen are up 42% to $405 at the time of writing.&nbsp;

Moderna Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrna#NASDAQ">MRNA</a>) shares gapped down Thursday and have since gained back some ground.
Moderna <a href="https://www.benzinga.com/news/earnings/21/05/20985333/moderna-stock-drops-as-q1-sales-fails-to-meet-expectations-anticipates-19-2b-in-fy21-product-sales">reported first-quarter earnings</a> Thursday of $2.84 per share, beating the estimate of $2.39. Moderna&#39;s quarterly sales were $1.9 billion, missing the Street estimate of $2.04 billion.
The company also announced a new supply agreement with Switzerland for 7 million doses of vaccine.
Moderna shares were trading down 2.63% at $158.56 at last check.&nbsp;<img alt="mrnadaily5-6-21.png" src="https://www.benzinga.com/files/u285825/mrnadaily5-6-21.png" style="height:400px; width:640px" />
<h3>Moderna Daily Chart Analysis</h3>
Moderna looks to be trading in what technical traders&nbsp;call an ascending triangle pattern.
The stock fell to the 50-day moving average (green) Thursday morning and is looking to hold the level as support.
The stock is trading above the 200-day moving average (blue), and both of these moving averages may hold as support in the future.
<h3>Key Moderna Levels To Watch</h3>
The stock looks to be trading in an ascending triangle pattern and could see a break in the pattern in a few weeks.
The $190 level has previously held as resistance for&nbsp;the stock and may hold again in the future.
The stock has been uptrending the past few months by forming higher lows on the chart. This trendline may hold as an area of support.
<h3>What&rsquo;s Next For Moderna?&nbsp;</h3>
Bullish technical traders would like to see the stock break above the $190 level and consolidate. After consolidation above resistance, bulls could see the stock make its next leg up.
Bearish technical traders would like to see the stock fail to hold the higher low support. Below this support, the stock may see a strong downward push.&nbsp;
Moderna is a top five&nbsp;holding in the following ETFs: ETFMG Treatments Testing and Advancements ETF (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/germ#NYSE">GERM</a>), Vaneck Vectors Trust Biotech ETF (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/bbh#NYSE">BBH</a>)&nbsp;and iShares Trust Nasdaq Biotechnology ETF (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/ibb#NYSE">IBB</a>)

The biotechnology space is always fertile territory for mergers and acquisitions, and that theme was on display over the weekend when AstraZeneca (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/azn#NYSE">AZN</a>) <a href="https://www.benzinga.com/general/biotech/20/12/18763050/astrazeneca-to-buy-rare-disease-specialist-drugmaker-alexion-for-39-billion">announced a $39-billion takeover</a> of&nbsp;Alexion Pharmaceuticals (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/alxn#NASDAQ">ALXN</a>).
U.K.-based AstraZeneca, which is one of the prime players in the COVID-19 vaccine race, is valuing Alexion at $175 per&nbsp;share in this year&#39;s biggest pharmaceuticals takeover.
&ldquo;Alexion has established itself as a leader in complement biology, bringing life-changing benefits to patients with rare diseases. This acquisition allows us to enhance our presence in immunology. We look forward to welcoming our new colleagues at Alexion so that we can together build on our combined expertise in immunology and precision medicines to drive innovation that delivers life-changing medicines for more patients,&rdquo; AstraZeneca CEO Pascal Soriot said&nbsp;<a href="https://finance.yahoo.com/news/astrazeneca-acquire-alexion-accelerating-companys-124800374.html">in a release</a>.
As of the Dec. 11 close, Alexion had a market value of just over $26 billion, meaning it&#39;s a decent-sized player in a variety of <a href="https://www.benzinga.com/trading-ideas/long-ideas/20/12/18764597/new-etf-from-adasina-social-capital-gets-to-heart-of-social-justice-investing">exchange traded funds</a>. Here are a few &ldquo;Alexion ETFs&rdquo; that could be in for a big day&nbsp;Monday.
Invesco Dynamic Biotechnology &amp; Genome ETF (PBE)
The Invesco Dynamic Biotechnology &amp; Genome ETF (NYSEARCA: PBE) <a href="https://www.invesco.com/us/financial-products/etfs/product-detail?productId=ETF-PBE">has a 4.55% weight</a> to Alexion as of Dec. 11, putting the fund in the upper tiers of ETFs in terms of weight to Astra&#39;s new target. That makes Alexion PBE&#39;s eighth-largest holding.
The $250.5-million PBE, which is 15.5 years old, holds 30 stocks with an average market capitalization of $25.23 billion, meaning there are other credible takeover targets in this ETF.
PBE tracks the Dynamic Biotech &amp; Genome Intellidex Index, which is &ldquo;based on a variety of investment merit criteria, including price momentum, earnings momentum, quality, management action, and value,&rdquo; according to Invesco.
VanEck Biotech ETF (BBH)
The VanEck Biotech ETF (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bbh#NASDAQ">BBH</a>) has a 4.71% Alexion weight as of Dec. 11, making the stock the fund&#39;s fifth-largest holding. That&#39;s decent Alexion exposure among ETFs, but the tails that wag the BBH dog are Amgen (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/amgn#NASDAQ">AMGN</a>) and Moderna (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrna#NASDAQ">MRNA</a>), which combine for 24.42% of the fund&#39;s weight.
Along with Moderna, BBH has some other coronavirus vaccine exposure, helping the fund to a year-to-date gain of almost 23%. In other words, the Alexion takeover news is just gravy for BBH.
First Trust NYSE Arca Biotechnology Index Fund (FBT)
The First Trust NYSE Arca Biotechnology Index Fund (NYSEARCA: FBT) allocates just over 3% of its weight to Alexion, putting it third by that metric behind the aforementioned PBE and BBH.
FBT is home to 30 stocks. Moving beyond the Alexion news, a case can be made that up to half of FBT holdings are legitimate takeover targets and probably 10%, or slightly more, of the fund&#39;s components are realistic buyers.

3 ETFs For AstraZeneca's $39B Alexion Pharmaceuticals Takeover

For the first four months of the market&rsquo;s cornavirus recovery, one of the key themes was the dominance of biotech.&nbsp;
In the 15 weeks from the market&rsquo;s lows on March 23 until July 17, the VanEck Vectors Biotech ETF (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/bbh#NYSE">BBH</a>) rallied nearly 60% and took in inflows of nearly $84 million. The fund flew past its previous all-time high of $141 to a new all-time high of $172 thanks to massive rallies in stocks like Amgen Inc (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/amgn#NASDAQ">AMGN</a>), Moderna Inc (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrna#NASDAQ">MRNA</a>), and Regeneron Pharmaceuticals Inc (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/regn#NASDAQ">REGN</a>), all of which have made new all-time highs this summer.&nbsp;
Much of this optimism has been driven by the development of vaccine and treatment candidates for COVID-19. Moderna has a $1.5 billion deal to supply the U.S. government with 100 million doses of its vaccine candidate should the drug pass Phase 3 testing. Regeneron meanwhile is working with Roche to develop, manufacture, and distribute its own coronavirus antibody cocktail.&nbsp;
Compare the performance of biotech to the performance of the VanEck Vectors Pharmaceutical ETF (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/pph#NYSE">PPH</a>) over that same period.&nbsp;
The pharma trade was no slouch&mdash;BBH rose nearly 40% and took in over $21 million of inflows on the backs of stocks like AstraZeneca (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/azn#NYSE">AZN</a>), Johnson &amp; Johnson (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/jnj#NYSE">JNJ</a>) and Sanofi (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/sny#NYSE">SNY</a>)&mdash;but it had nothing on biotech from mid-March to mid-July.&nbsp;
But over the past six weeks, there has been a divergence between the two. The previously high-flying biotech trade has cooled significantly, while its pharmaceuticals counterpart has moved steadily higher.&nbsp;
Perhaps pausing for a breather after a rip-roaring rally, PPH has fallen 11% from its all-time high on July 20. This as a number of the fund&rsquo;s top holdings have snapped back as we continue to await word on late-stage testing results.&nbsp;
Pharmaceuticals, on the other hand, have held up much better on a relative basis. BBH is down a mere 1.5% since July 20 and has consolidated heavily over the past two weeks (price consolidations can sometimes foreshadow a breakout).&nbsp;
Sanofi and GlaxoSmithKline (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/gsk#NYSE">GSK</a>) have received $2.1 of funding from the U.S. government for funding of their joint vaccine candidate, while Johnson &amp; Johnson plans to start a late-stage trial for its coronavirus vaccine in late September.
<img src="https://lh6.googleusercontent.com/nvUrpQJQ3W9Ev7P4roRC-Ep8AsAYcO43dD9VBn243amq5b14rNQB9_wDV3R8g-tK_F6aiAWA61i8Gblv1PoWMMhBjbrjQpXfTudhGxtHH-2ce7uZS_xapCCnvKgnUCd3J77-XKLM" style="height:377px; width:624px" /> 
BBH (purple line) and PPH (candlesticks) both rallied from March-July, one has held up better than the other in August. Source: <a href="http://pro.benzinga.com">Benzinga Pro</a>
It&rsquo;s unlikely sentiment has turned fully sour on biotech, however. PPH has still taken in nearly $17 million of new assets over the past six weeks, and according to the Wall Street Journal U.S.-listed biotech companies have already raised a record amount of money via IPOs in 2020. 
&nbsp;

Merrill Lynch Pharmaceutical HOLDRs Trust

REGN

A Divergence Has Occurred In Healthcare

In the race to develop a coronavirus vaccine, AstraZeneca (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/azn#NYSE">AZN</a>) and Gilead Sciences (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gild#NASDAQ">GILD</a>) are two of the leading contenders and that could be the starting point of a massive marriage, according to recent reports.
News broke Sunday that UK-based AstraZeneca <a href="https://www.bloomberg.com/news/articles/2020-06-07/big-pharma-looks-beyond-covid-with-astrazeneca-eyeing-gilead?utm_content=business&amp;utm_source=twitter&amp;cmpid=socialflow-twitter-business&amp;utm_medium=social&amp;utm_campaign=socialflow-organic">made an initial overture</a> to Gilead, the company behind the remdesivir COVID-19 drug. If the talks progress and a deal is struck, it would be the largest ever in the health care sector.
Gildead&#39;s closing market value last Friday was north of $97 billion, meaning that if a marriage is consummated, AstraZeneca will be doling out well over $100 billion.
With that in mind, here are some Gildead-heavy ETFs to consider over the next few days.
<h3>iShares Nasdaq Biotechnology ETF (IBB)</h3>
The iShares Nasdaq Biotechnology ETF (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ibb#NASDAQ">IBB</a>) is the largest ETF of its kind and features a 7.72% to Gilead, making the stock the <a href="https://www.ishares.com/us/products/239699/?referrer=tickerSearch">second-largest component</a> in the fund.
With Moderna (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrna#NASDAQ">MRNA</a>) also among its top 10 holdings, IBB has ample COVID-19 vaccine exposure. What&#39;s interesting about the AstraZeneca/Gilead rumor is that it shifts the mergers and acquisitions conversation pertaining to IBB to an ETF potentially being home to targets rather than buyers, though it probably still has plenty of both.
Benzinga is covering every angle of how the coronavirus affects the financial world.&nbsp;For daily updates,&nbsp;<a href="https://share.hsforms.com/1UT8L-e6gSUiP288QJFLp2A1npzh">sign up for our coronavirus newsletter</a>.
<h3>VanEck Vectors Biotech ETF (BBH)</h3>
The VanEck Vectors Biotech ETF (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/bbh#NYSE">BBH</a>) holds just 24 stocks, but Gilead is this $455 million fund&#39;s second-largest holding at a weight of 8.47%. That&#39;s one of the top Gilead weights among all ETFs.
Plus, BBH also has one of the biggest Moderna allocations at 7.33%. That combination goes a long way in explaining why BBH is higher by 32% over the past year.
&ldquo;Gilead Sciences and Moderna are two of BBH&rsquo;s top 10 holdings. Gilead recently indicated that the trial for coronavirus treatment Remdesivir has met its initial goal, and the U.S. Food and Drug Administration (FDA) is fast tracking Moderna&rsquo;s experimental COVID-19 vaccine through the regulatory review process,&rdquo; <a href="https://www.vaneck.com/etf/equity/bbh/overview/">according to VanEck</a>.
<h3>Deep Value ETF (DVP)</h3>
Here&#39;s a surprise. Rarely are biotechnology stocks thought of as value plays and rarely do value ETFs hold such names, but the Deep Value ETF (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/dvp#NYSE">DVP</a>) allocates almost 7% of its weight to Gilead. DVP follows the Deep Value Index.
&ldquo;The Index is comprised of 20 undervalued dividend paying stocks within the S&amp;P 500 Index with solid balance sheets, earnings and strong free cash flow,&rdquo; <a href="https://dvpfund.com/">according to the issuer</a>. &ldquo;The companies within the Index are weighted based on a rules-based assessment of their valuations so that stocks that are most attractively valued receive a higher weight.&rdquo;

Broad U.S. Equity ETFs

Rumors

3 Gilead-Heavy ETFs To Watch Amid The AstraZeneca-Gilead Rumor

Here&#39;s a roundup of top developments in the biotech space over the last 24 hours:
<h3>
	Scaling the Peaks</h3>
(Stocks hitting 52-week highs on May 3)
<ul>
<li>
		ABIOMED, Inc. (NASDAQ: <a class="ticker" href="/stock/abmd#NASDAQ">ABMD</a>) (reported better-than-expected Q4 results)</li>
<li>
		AveXis Inc (NASDAQ: <a class="ticker" href="/stock/avxs#NASDAQ">AVXS</a>) (reported Q1 results and provided corporate update and details on upcoming milestones)</li>
<li>
		Enanta Pharmaceuticals Inc (NASDAQ: <a class="ticker" href="/stock/enta#NASDAQ">ENTA</a>)</li>
<li>
		Integra Lifesciences Holdings Corp (NASDAQ: <a class="ticker" href="/stock/iart#NASDAQ">IART</a>)</li>
</ul>
<h3>
	Down In The Dumps</h3>
(Stocks hitting 52-week lows on May 3)
<ul>
<li>
		Akorn, Inc. (NASDAQ: <a class="ticker" href="/stock/akrx#NASDAQ">AKRX</a>) (has been on a slide since Wednesday following Fresenius SE&#39;s allegation that it submitted fraudulent data to the FDA regarding its antibiotic azithromycin)</li>
<li>
		Altimmune Inc (NASDAQ: <a class="ticker" href="/stock/alt#NASDAQ">ALT</a>)</li>
<li>
		Anika Therapeutics Inc (NASDAQ: <a class="ticker" href="/stock/anik#NASDAQ">ANIK</a>) (announced Q1 miss and product recall)</li>
<li>
		Gemphire Therapeutics Inc (NASDAQ: <a class="ticker" href="/stock/gemp#NASDAQ">GEMP</a>)</li>
<li>
		IntelliPharmaCeutics Intl Inc (USA) (NASDAQ: <a class="ticker" href="/stock/ipci#NASDAQ">IPCI</a>)</li>
<li>
		Mallinckrodt PLC (NYSE: <a class="ticker" href="/stock/mnk#NYSE">MNK</a>)</li>
<li>
		Regeneron Pharmaceuticals Inc (NASDAQ: <a class="ticker" href="/stock/regn#NASDAQ">REGN</a>)(reported Q1 EPS beat, In-line revenues; lowered Sanofi collaboration revenue guidance for FY18)</li>
<li>
		RXi Pharmaceuticals Corp (NASDAQ: <a class="ticker" href="/stock/rxii#NASDAQ">RXII</a>)</li>
<li>
		Titan Pharmaceuticals, Inc. common stock (NASDAQ: <a class="ticker" href="/stock/ttnp#NASDAQ">TTNP</a>)</li>
<li>
		VanEck Vectors Biotech ETF (NASDAQ: <a class="ticker" href="/stock/bbh#Nasdaq">BBH</a>)</li>
</ul>
<h3>
	Stocks In Focus</h3>
<h3>
	FDA Greenlights Portola&#39;s Bleeding Control Drug</h3>
Portola Pharmaceuticals Inc (NASDAQ: <a class="ticker" href="/stock/ptla#NASDAQ">PTLA</a>) announced the FDA <a href="https://www.benzinga.com/pressreleases/18/05/g11644752/u-s-fda-approves-portola-pharmaceuticals-andexxa-first-and-only-antido">approved</a> its Andexanet alfa, a factor Xa inhibitor reversal agent. The <a href="https://www.benzinga.com/analyst-ratings/analyst-color/17/12/10955415/portola-pharma-shares-under-pressure-after-fda-extensio">company</a> said it&#39;s the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
The company said it will initiate a trial in 2019 to meet post-marketing requirement, the results of which are due in 2023.
The company expects to launch the product under an Early Supply Program with a Generation 1 product in June, while a commercial launch is planned in early 2019, contingent on FDA&#39;s vetting of the generation 2 manufacturing process.
The stock rose 26 percent to $42.66 in Friday&#39;s pre-market session.
<h3>
	FDA Panel Votes Against Mallinckrodt&#39;s Jaundice Drug</h3>
A joint meeting of the Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee, which discussed Mallinckrodt PLC (NYSE: <a class="ticker" href="/stock/mnk#NYSE">MNK</a>) unit InfaCare Pharma&#39;s NDA for stannsoporfin injection, intramuscular formulation, <a href="https://www.benzinga.com/pressreleases/18/05/r11644379/mallinckrodt-reports-on-fda-joint-advisory-committee-meeting-for-stann">ruled by a 21-3 vote</a> that the risk-benefit profile of it doesn&#39;t support approval for the treatment of neonates greater than or equal to 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia.
The <a href="https://www.benzinga.com/analyst-ratings/analyst-color/17/12/10956160/analyst-why-the-sucampo-deal-is-a-smart-move-for-mallin">company</a> said following the FDA panel vote, it is evaluating alternatives for the development program.
See Also: <a href="https://www.benzinga.com/general/biotech/18/05/11600569/attention-biotech-investors-mark-your-calendar-for-these-may-pdufa-ac">Attention Biotech Investors: Mark Your Calendar For These May PDUFA Action Dates</a>
<h3>
	Adamas Reports Q1 Beat</h3>
Adamas Pharmaceuticals Inc (NASDAQ: <a class="ticker" href="/stock/adms#NASDAQ">ADMS</a>) <a href="https://www.benzinga.com/pressreleases/18/05/g11641703/adamas-reports-first-quarter-2018-financial-results">reported</a> a narrower-than-expected Q1 loss of $1.35 per share, and revenues also exceeded estimates. The stock rallied 5.54 percent to $31.41 in after hours.
<h3>
	Twin Executive Departures at Adverum</h3>
Adverum Biotechnologies Inc (NASDAQ: <a class="ticker" href="/stock/advm#NASDAQ">ADVM</a>) shares slumped 9.37 percent to $5.755 after the company <a href="https://www.benzinga.com/pressreleases/18/05/g11642440/adverum-biotechnologies-announces-leadership-changes">announced</a>&nbsp;CEO Dr. Amber Salzman is stepping down, effective May 3. The company also said its chief medical officer Athena Countouriotis will depart, effective May 11.
<h3>
	TESARO Misses On Both Top- and Bottom-line</h3>
TESARO <a href="https://www.benzinga.com/pressreleases/18/05/g11641689/tesaro-announces-first-quarter-2018-operating-results">reported</a> a Q1 net loss of $2.98 per share compared to the $2.70 loss expected by analysts. Revenues of $50.17 million also trailed the consensus estimate of $56.93 million. The stock slid 2.81 percent to $47 in after hours Thursday.
<h3>
	Aratana Posts Q1 Revenue Miss</h3>
Aratana Therapeutics Inc (NASDAQ: <a class="ticker" href="/stock/petx#NASDAQ">PETX</a>) shares lost 5.94 percent to $4.75 after it <a href="ttps://www.benzinga.com/pressreleases/18/05/r11641660/aratana-therapeutics-reports-first-quarter-2018-financial-results">reported</a> a Q1 loss of 19 cents per share, narrower than the 20 cents loss expected. Revenues were below consensus.
<h3>
	Akcea Posts Above-consensus Q1 Revenues, Announces Extension of PDUFA Date</h3>
Akcea Therapeutics Inc (NASDAQ: <a class="ticker" href="/stock/akca#NASDAQ">AKCA</a>) <a href="https://www.benzinga.com/pressreleases/18/05/g11641662/akcea-reports-financial-results-and-highlights-for-first-quarter-2018">announced</a>&nbsp;the FDA extended the PDUFA date for its tegsedi to Oct. 6, 2018, as the agency requires additional time to look at the responses presented to the standard requests. The company also reported above-consensus FQ1 revenues, while it posted a loss for the quarter.
The stock slumped 5.7 percent to $22.60.
<h3>
	Other Stocks That Reacted to Earnings</h3>
<ul>
<li>
		TherapeuticsMD Inc (NASDAQ: <a class="ticker" href="/stock/txmd#NASDAQ">TXMD</a>) &ndash; Up 1.59 percent</li>
<li>
		Sarepta Therapeutics Inc (NASDAQ: <a class="ticker" href="/stock/srpt#NASDAQ">SRPT</a>) &ndash; Down 2.5 percent</li>
<li>
		NewLink Genetics Corp (NASDAQ: <a class="ticker" href="/stock/nlnk#NASDAQ">NLNK</a>) &ndash; Up 2.67 percent</li>
<li>
		Spectrum Pharmaceuticals, Inc. (NASDAQ: <a class="ticker" href="/stock/sppi#NASDAQ">SPPI</a>) &ndash; Up 4.3 percent</li>
<li>
		Alnylam Pharmaceuticals, Inc. (NASDAQ: <a class="ticker" href="/stock/alny#NASDAQ">ALNY</a>) &ndash; Up 1.35 percent</li>
</ul>
<h3>
	On The Radar</h3>
The following companies report earnings on Friday:
<ul>
<li>
		ACADIA Pharmaceuticals Inc. (NASDAQ: <a class="ticker" href="/stock/acad#NASDAQ">ACAD</a>) Q1 EPS $(0.44) Beats $(0.56) Estimate, Sales $48.868M Beat $47.06M Estimate</li>
<li>
		Achaogen Inc (NASDAQ: <a class="ticker" href="/stock/akao#NASDAQ">AKAO</a>) Q1 EPS $(1.06) Misses $(0.89) Estimate, Sales $2.1M Beat $1.14M Estimate</li>
<li>
		Agios Pharmaceuticals, Inc. (NASDAQ: <a class="ticker" href="/stock/agio#NASDAQ">AGIO</a>) Q1 EPS $(1.63), Inline, Sales $8.762M Miss $10.6M Estimate</li>
<li>
		Celgene Corporation (NASDAQ: <a class="ticker" href="/stock/celg#NASDAQ">CELG</a>) Q1 EPS $2.05 Beats $1.96 Estimate, Sales $3.531B Beat $3.46B Estimate</li>
<li>
		ImmunoGen, Inc. (NASDAQ: <a class="ticker" href="/stock/imgn#NASDAQ">IMGN</a>) Q1 EPS $(0.30) Misses $(0.24) Estimate, Sales $19.815M Beat $15.04M Estimate</li>
<li>
		Ionis Pharmaceuticals Inc (NASDAQ: <a class="ticker" href="/stock/ions#NASDAQ">IONS</a>) Q1 EPS $(0.01) Beats $(0.04) Estimate, Sales $144.41M Miss $145.29M Estimate</li>
</ul>

ABMD

ACAD

ADMS

ADVM

AGIO

AKAO

AKCA

AKRX

ALNY

ANIK

AVXS

CELG

ENTA

GEMP

IART

IMGN

IONS

IPCI

NLNK

PETX

PTLA

RXII

SPPI

SRPT

SRTS

TTNP

TXMD

Benzinga's Daily Biotech Pulse: Portola Receives FDA Nod, Mallinckrodt Gets Thumbs Down

So far, it&#39;s been a good year for biotech stocks with the Nasdaq Biotechnology Index soaring 19.6% year to date. This is in sharp contrast to last year&#39;s performance when the Index was down 19.1% with several factors including the drug pricing controversy weighing on the sector.
2016 was disappointing from an R&amp;D perspective as well with a fewer number of drugs managing to gain FDA approval and quite a few companies suffering from high-profile pipeline failures. Mixed results, slower-than-expected new product launches and increasing competition were some of the other challenges for the sector. &nbsp;(Read: <a href="https://www.zacks.com/stock/news/282691/time-to-buy-global-low-volatility-etfs">Time to Buy Global Low Volatility ETFs?</a>)
However, ramp up in new product sales, R&amp;D success and innovation, strong results, a higher number of FDA approvals and continued strong performance from key products are some of the factors that have helped the sector recover this year. Moreover, investors now seem more comfortable with the drug pricing scenario and are focusing more on the fundamentals of the sector.
Increasing Threat from Biosimilars
Although biosimilars are yet to pick pace, they remain a major threat for biotech stocks specially companies that are set to lose patent protection for major blockbuster drugs in the next few years. While a relatively new area, the market for biosimilars is huge and highly lucrative with several blockbuster biologics including Humira and Lantus slated to lose patent protection by 2020. Biosimilars are expected to reduce healthcare costs and provide a large number of patients with access to much needed biologic treatments. Biosimilars are also gaining acceptance across formularies.
According to information provided by Express Scripts, about $250 billion could be saved in the next decade (2014 &ndash; 2024) if biosimilars for 11 products including Neupogen, Avastin, Epogen, Humira, Neulasta, Remicade and Rituxan are approved. According to the company, Neupogen and Remicade biosimilars alone represent potential savings of more than $22 billion.
Mergers and Acquisitions (M&amp;As) Yet to Pick Pace
Although expectations were high that M&amp;A activity would pick up in 2017, this did not happen. While several small deals were announced, big-ticket M&amp;A activity was more or less limited with major acquisition news including Johnson &amp; Johnson&#39;s&nbsp;$30 billion acquisition of Actelion and&nbsp;Gilead&#39;s&nbsp;$11.9 billion acquisition of Kite. (Read: <a href="https://www.zacks.com/stock/news/281883/7-topranked-tech-etfs-on-unstoppable-rally">7 Top-Ranked Tech ETFs on Unstoppable Rally</a>)
The sector will receive an additional boost if more M&amp;A deals are announced, though companies are likely to adopt a &quot;wait and see&quot; stance as they await more clarity on the drug pricing situation and tax reforms. Another major deterrent could be high valuations with companies remaining wary of bidding wars leading to over-priced deals.
Higher Number of Drugs Approved So Far in 2017
So far in 2017, the FDA has granted approval to 34 novel drugs, surpassing last year&#39;s total tally of 22. Key approvals in the biotech sector this year include Gilead&#39;s Yescarta (CAR-T therapy for certain types of large B-cell lymphoma) and Vosevi (hepatitis C virus), Puma&#39;s Nerlynx (to reduce the risk of breast cancer returning), Regeneron/Sanofi&#39;s Kevzara (rheumatoid arthritis) and eczema treatment, Dupixent, TESARO&#39;s PARP inhibitor, Zejula and BioMarin&#39;s Brineura (treatment of a specific form of Batten disease) among others. Quite a few of these drugs have blockbuster potential.
The FDA is working on streamlining the development process for drugs for rare diseases as well as for targeted cancer therapies. The agency is also working on clearing up a backlog of orphan drug applications. (Read: <a href="https://www.zacks.com/stock/news/282424/top-ranked-tech-etfs-for-long-term-investors">Top Ranked Tech ETFs for Long Term Investors</a>)
Innovative Pipelines &amp; Catalysts
Biotech companies continue to work on bringing innovative new treatments to market, and there could be significant catalysts in the coming quarters in the form of important new product approvals as well as major data read-outs especially in key therapeutic areas like immuno-oncology, Alzheimer&#39;s, central nervous system disorders, and immunology/inflammation.
ETFs in Focus
Highlighted below are some biotech ETFs -- ETFs present a low-cost and convenient way to get a diversified exposure to the sector.
iShares Nasdaq Biotechnology&nbsp;(IBB)&nbsp;&nbsp;
IBB, launched in February 2001 by BlackRock Investments LLC, tracks the Nasdaq Biotechnology Index. The fund mainly covers biotech stocks (81.9%) with pharma accounting for 9.3%. The top 3 holdings include Amgen (8.4%), Biogen Inc. (8.28%) and Gilead Sciences, Inc. (7.85%). The total assets of the fund as of Oct 30, 2017 were $9.65 billion representing 159 holdings. The fund&#39;s expense ratio is 0.47% while dividend yield is 0.22%. The trading volume is roughly 1,268,319 shares per day.
SPDR S&amp;P Biotech ETF&nbsp;(XBI)
XBI, launched in January 2006 by State Street Global Advisors, tracks the S&amp;P Biotechnology Select Industry Index. The fund covers health care stocks only. Key holdings include Juno Therapeutics, Inc. (2.61%), Sarepta Therapeutics (2.51%), and Exelixis, Inc. (2.42%). The total assets of the fund as of Oct 30, 2017 were $4 billion representing 102 holdings. The fund&#39;s expense ratio is 0.35% while dividend yield is 0.22%. The trading volume is roughly 4,782,719 shares per day.
First Trust NYSE Arca Biotech ETF&nbsp;(FBT)
FBT, launched in June 2006 by First Trust Advisors, tracks the NYSE Arca Biotechnology Index. The top 3 holdings include Alnylam Pharmaceuticals, Inc. (3.68%), Juno Therapeutics, Inc. (3.64%), and Neurocrine&nbsp;Biosciences, Inc. (3.61%). The total assets of the fund as of Oct 27, 2017 were $1.2 billion representing 30 holdings. The fund&#39;s expense ratio is 0.56% while dividend yield is nil. The trading volume is roughly 33,108 shares per day.
VanEck Vectors Biotech ETF&nbsp;(ETF:BBH)
BBH, launched in December 2011 by Van Eck, tracks the Market Vectors US Listed Biotech 25 Index. The fund covers health care stocks. The top 3 holdings include Amgen (11.62%), Celgene Corporation (11.26%) and Gilead Sciences Inc. (11.18%). The total assets of the fund as of Oct 30, 2017 were $668.8 million representing 25 holdings. The fund&#39;s expense ratio is 0.35% while dividend yield is 0.2%. The trading volume is roughly 43,186 shares per day.
PowerShares Dynamic Biotech &amp; Genome ETF&nbsp;(PBE)
PBE, launched in June 2005 by Invesco PowerShares, tracks the Dynamic Biotech &amp; Genome Intellidex Index. The top 3 holdings include Illumina, Inc. (5.31%), Biogen (5.29%), and Gilead Sciences, Inc. (5.11%). The total assets of the fund as of Oct 30, 2017 were $237 million representing 31 holdings. The fund&#39;s expense ratio is 0.58% while dividend yield is 0.84%. The trading volume is roughly 13,247 shares per day.
Conclusion
Although the sector may face some volatility due to the drug pricing issue, pipeline success in innovative and important therapeutic areas, cost-cutting, share buybacks, new products, increased pipeline visibility and appropriate utilization of cash should help maintain investor confidence in this sector.&nbsp;
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Biotech ETFs: What Lies Ahead?

The earnings season is off to a flying start with almost 75% of the companies having surpassed expectations. The performance has been quite impressive for Biotech companies, with major players beating market estimates. President Donald Trump&#39;s failure to implement the healthcare bill was a positive for the biotech space (read: <a href="https://www.zacks.com/stock/news/268798/can-biotech-etfs-continue-to-surge-higher">Can Biotech ETFs Continue to Surge Higher?</a>).

	This week four major biotech players announced their quarterly results. Amgen Inc AMGN, Gilead Sciences GILD, Biogen Inc BIIB and Alexion Pharmaceuticals ALXN, all beat earnings and revenue estimates (read: <a href="https://www.zacks.com/stock/news/266090/forget-big-tech-biotech-etfs-are-soaring-higher">Forget Big Tech, Biotech ETFs are Soaring Higher</a>).

	Earnings in Focus

	<a href="http://investors.amgen.com/phoenix.zhtml?c=61656&amp;p=irol-newsArticle&amp;ID=2288639">Amgen </a>reported second-quarter 2017 adjusted earnings of $3.27 per share on July 25, 2017, beating the Zacks Consensus Estimate of $3.09 and increasing more than 15.1% from $2.84 per share in the year-ago quarter. Moreover, it also beat the consensus estimate on the revenue front. The company reported revenues of $5.810 billion, which surpassed the consensus estimate of $5.666 billion and increased 2.14% from $5.688 billion in the year-ago quarter.

	The company updated its full-year non-GAAP EPS guidance to the range of $12.15&ndash;$12.65 from $12&ndash;$12.6. It also updated its revenue guidance to the range of $22.5&ndash;$23 billion from $22.3&ndash;$23.1 billion. The company&#39;s shares lost around 3.2% at market close on July 26, 2017, after its updated guidance fell short of analyst expectations.

	<a href="http://investors.gilead.com/phoenix.zhtml?c=69964&amp;p=irol-newsArticle&amp;ID=2289028">Gilead Sciences</a> reported second-quarter 2017 adjusted earnings of $2.51 per share on July 26, 2017, beating the Zacks Consensus Estimate of $2.11, but decreasing more than 17.1% from $3.03 per share in the year-ago quarter. Moreover, it also beat the consensus estimate on the revenue front. The company reported revenues of $7.141 billion, which surpassed the consensus estimate of $6.359 billion but decreased more than 8.1% from $7.776 billion in the year-ago quarter.

	The company updated its full-year revenue guidance to the range of $24&ndash;$25.5 billion from $22.5&ndash;$24.5 billion. The company&#39;s shares gained around 0.95% at market close on July 27, 2017, owing to the EPS and revenue beat.

	<a href="http://media.biogen.com/press-release/investor-relations/biogen-reports-record-quarterly-revenues-31-billion-raises-full-yea">Biogen Inc</a> reported second-quarter adjusted earnings per share of $5.04 on July 25, 2017, beating the Zacks Consensus Estimate of $4.36 but decreasing more than 3.2% from $5.21 per share in the year-ago quarter. The company reported revenues of $3.078 billion, which surpassed the consensus estimate of $2.812 billion and increased roughly 6.35% from $2.894 billion in the year-ago quarter.

	The company updated its full-year non-GAAP EPS guidance to the range of $20.8&ndash;$21.4 from $20.45&ndash;$21.25. It also increased its revenue guidance to $11.5&ndash;$11.8 billion. The company&#39;s shares gained more than 3% in pre-market trading due to the better-than-expected results but closed around 1% lower on July 25, 2017.

	<a href="http://news.alexionpharma.com/press-release/financial-news/alexion-reports-second-quarter-2017-results">Alexion Pharmaceuticals Inc</a> reported second -quarter adjusted earnings per share of $1.31 on July 27, 2017, beating the Zacks Consensus Estimate of $1.08 and increasing roughly 40.9% from $0.93 per share in the year-ago quarter. The company reported revenues of $912 million, which surpassed the consensus estimate of $848 million and increased roughly 21.1% from $753 million in the year-ago quarter.

	The company updated its full-year non-GAAP EPS guidance to the range of $5.4&ndash;$5.55 and increased its revenue guidance to $3.45&ndash;$3.525 billion. The company&#39;s shares were up around 2.20% at market close on July 27, 2017, primarily due to the better-than-expected results.

	We will now discuss a few ETFs with high exposure to the companies discussed.

	iShares Nasdaq Biotechnology ETF IBB

	This fund seeks to provide exposure to the biotech industry. It has AUM of $9.91 billion and charges a fee of 47 basis points a year. The fund has 8.38% exposure to Biogen, 8.03 to Gilead, 7.96% to Amgen and 4.26% to Alexion (as of July 26, 2017). The fund has returned 10.49% in the last one year and 20.5% year to date (as of July 27, 2017). It currently has a Zacks ETF Rank #2 (Buy) with a High risk outlook (read: <a href="https://www.zacks.com/stock/news/266088/how-kite-pharma-is-revolutionizing-the-fight-against-cancer">How Kite Pharma Is Revolutionizing the Fight Against Cancer</a>).

	VanEck Vectors Biotech ETF BBH

	This fund has AUM of $699.9 million and charges a fee of 35 basis points a year. The fund has 11.22% exposure to Amgen, 10.37% to Gilead, 5.87% to Biogen and 5.44% to Alexion (as of July 27, 2017). The fund has returned 12.35% in the last one year and 20.47% year to date (as of July 27, 2017). It currently has a Zacks ETF Rank #2 with a High risk outlook (read: <a href="https://www.zacks.com/stock/news/265297/5-reasons-why-biotech-etfs-are-soaring">5 Reasons Why Biotech ETFs are Soaring</a>).

	Ultra Nasdaq Biotechnology ETF BIB

	This fund has AUM of $470.81 million and charges a fee of 95 basis points a year. The fund has 8.33% exposure to Biogen, 7.98% to Gilead, 7.91% to Amgen and 4.23% to Alexion (as of July 26, 2017). The fund has returned 15.75% in the last one year and 41.79% year to date (as of July 27, 2017).

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Previews

3 ETFs To Watch Out For On Biotech Earnings

Putting personal politics aside for a moment, it is not unreasonable to assume that investors who were long biotechnology stocks and exchange-traded funds into Election Day are happy with the outcome.
Leading up to Election Day, Democratic nominee Hillary Clinton and her harsh rhetoric against high drug prices, a worthy issue to raise against, were seen as the primary factors behind the struggles of biotechnology stocks and ETFs this year. Obviously, Clinton did not win the White House, and biotechnology ETFs responded positively to that scenario.
For example, the VanEck Vectors Biotech ETF (NASDAQ: BBH) is higher by 13 percent this year. BBH tracks the MVIS US Listed Biotech 25 Index (MVBBHTR), &ldquo;which is intended to track the overall performance of companies involved in the development and production, marketing and sales of drugs based on genetic analysis and diagnostic equipment,&rdquo; <a href="https://www.vaneck.com/funds/BBH.aspx">according to VanEck</a>.
There are always potential catalysts looming for biotech stocks and ETFs, namely drug approvals and trials and mergers and acquisitions. Next year could bring more of at least one of those two themes. Still, some investors may be concerned that biotech stocks and ETFs have rallied too far, too fast following the election.
<h3>The 'Trump Bump'</h3>
&ldquo;Biotechnology&rsquo;s sudden &#39;Trump-bump&#39; after Election Day is not surprising. In the past year, amidst increasing political campaign pressure and Hillary Clinton&rsquo;s enduring health care pricing-structure criticisms, large biotech stocks came under undue pressure and consequently experienced a sharp price decline,&rdquo; said VanEck <a href="https://www.vaneck.com/blogs/etfs/trump-bump-biotech/">in a recent note</a>. &ldquo;The pressure eased the morning after Election Day as industry experts expect President-elect Trump&rsquo;s pro-business stance to be beneficial for the biotech industry. His plan highlights business tax rate cuts from 35 percent to 15 percent, repeal of the Affordable Care Act incurred taxes on health care companies and wide-ranging cash repatriation initiatives, all three of which would potentially benefit large and profitable biotech companies.&rdquo;
<h3>Holdings</h3>
The $584.4 million BBH is home to 26 stocks, a lineup that <a href="http://www.benzinga.com/general/biotech/16/03/7725889/a-rare-opportunity-with-a-biotechnology-etf">is dominated by large-cap biotechs</a> such as Gilead Sciences, Inc. (NASDAQ: <a class="ticker" href="/stock/gild#NASDAQ">GILD</a>), Amgen, Inc. (NASDAQ: <a class="ticker" href="/stock/amgn#NASDAQ">AMGN</a>) and Celgene Corporation (NASDAQ: <a class="ticker" href="/stock/celg#NASDAQ">CELG</a>). Those stocks combine for about a third of BBH&#39;s weight.
Good news: Those stocks and other BBH holdings are sporting attractive valuations.
&ldquo;On a price-to-fair value basis, large biotech stocks traded at a 22 percent discount on average. Familiar names such as Gilead Sciences (GILD) traded at a 30 percent discount, Allergan (AGN) 29 percent and Amgen (AMGN) 25 percent compared to their respective fair value estimates,&rdquo; added VanEck.

Politics

Assessing The Legitimacy Of The Biotech ETF Bounce

Drug pricing has been one of the hot topics of the year. As Citron Research&#39;s controversial executive editor Andrew Left <a href="http://www.benzinga.com/analyst-ratings/analyst-color/16/09/8496510/andrew-left-on-valeant-eliminating-price-gouging-is-sole">said</a> last month, &ldquo;Regulating the price of pharmaceuticals and eliminating price gouging might be the only issue that Trump and Hillary both agree on.&rdquo;
Conversing with SunTrust Robinson Humphrey Managing Director and Senior Biotechnology Analyst Edward Nash and Associate Biotechnology Analyst Mike Guo, Benzinga had the chance to discuss drug pricing, an issue that goes well beyond Valeant Pharmaceuticals Intl Inc (NYSE: <a class="ticker" href="/stock/vrx#NYSE">VRX</a>), Mylan NV (NASDAQ: <a class="ticker" href="/stock/myl#NASDAQ">MYL</a>) or Martin Shkreli.
<bzrelatedlink>Related Link: <a href="http://www.benzinga.com/analyst-ratings/analyst-color/16/10/8570470/exclusive-suntrust-top-analysts-explain-fatty-liver-dise">Exclusive: SunTrust Top Analysts Explain Fatty Liver Diseases, Galmed&#39;s Potential In The Space</a></bzrelatedlink>
&ldquo;If you look at what we&rsquo;ve seen in the last year-and-a-half or two years, the issues that have popped up around pricing, have always been with older drugs that have been out there for a while, which have been rebranded, or had their patents extended, or just don&rsquo;t have any competition&hellip; and they&rsquo;ve had their prices dramatically increased overnight,&rdquo; Nash explained. So, controversy in these cases is quite easy to understand.
However, the expert added, this is not considered biotech. &ldquo;At some point, that is going to be the low hanging fruit&hellip; and that kind of gouging (if you want to call it that, which in some cases, it is) is where I think we would start to see the first, initial attempts to make some type of pricing changes there.&rdquo;
<bzrelatedlink>Related Link: <a href="http://www.benzinga.com/analyst-ratings/analyst-color/16/10/8564634/exclusive-suntrust-managing-director-goes-over-sarepta-t">Exclusive: SunTrust Managing Director Goes Over Sarepta Therapeutics&#39; Story</a></bzrelatedlink>
Nonetheless, he went on:
<ul>
<ol>
<li>&ldquo;Any changes that would come about&hellip; won&rsquo;t happen overnight&hellip; It takes time and a lot of work.&rdquo;</li>
<li>Companies in the biotech space, developing drugs that are the first approved for an indication, or drugs that target orphan indications, or drugs that offer much higher levels of efficacy or safety than pre-existing treatments, will always be able to charge a premium.</li>
</ol></ul>
&ldquo;So, normal biotech, while it does get affected by rumors and talk [about price gouging],&rdquo; would not feel a big impact over the near or longer term. Instead, Nash concluded, this is something that would have a larger impact on specialty pharmaceuticals and generics pharmaceuticals first.
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	Disclosure: Javier Hasse holds no interest in any of the securities or entities mentioned above.

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Exclusive: SunTrust Managing Director Shares Thoughts On Drug Pricing, Impact On Biotech

Hillary Clinton, Democratic presidential nominee, introduced a new plan to address the "unjustified" price increases on life-savings drugs that have become commonplace among some drug makers over the past few years.
According to <a href="http://www.reuters.com/article/us-usa-election-clinton-drugs-idUSKCN1181DM">Reuters,</a> Clinton plans on creating an oversight panel that will be tasked with protecting consumers from price increases on life-saving drugs. She also pledged to import alternative drugs and treatments if necessary to do so.
Clinton said that the panel will be provided with an "aggressive new set of enforcement tools" as well as the ability to slap drug makers with fines and even impose penalties for any "unjustified" price hikes.
The panel would consist of representatives from already existing public health and consumer protection agencies.
<bzrelatedlink>Related Link: <a href="http://www.benzinga.com/general/biotech/16/09/8417318/10-conditions-that-could-soon-be-treated-with-cannabis-from-menstrual-">10 Conditions That Could Soon Be Treated With Cannabis: From Menstrual Cramps To Autism</a></bzrelatedlink>
"Over the past year, we've seen far too many examples of drug companies raising prices excessively for long-standing, life-saving treatments with little or no new innovation or R&amp;D," Reuters quoted Clinton as saying in a statement.
There may be one problem with Clinton's proposal: She would need the blessing of the U.S. Congress to implement key measures of her proposals, including levying fines and fees.
Reuters also noted that lawmakers have historically resisted any motion to introduce controls on pharmaceutical prices. Lawmakers argued that lowering or limiting drug prices would interfere with drug markers' ability to invest in research and develop new therapies.
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Clinton's Proposal To Combat Drug Price Hikes

A frequent criticism of biotechnology stocks is that they usually trade at rich multiples, making the industry appear expensive not only to the rest of the healthcare sector, but the broader market as well. That was true when biotechnology stocks and exchange traded funds were making new highs through the middle of 2015.

	Applying that logic would imply that after significant losses that saw some marquee biotech enter or flirt with bear markets, these funds and their holdings could be inexpensive relative to historical norms. Data indicate that biotech stocks are in fact inexpensive relative to their illustrious history as one of most expensive corners of the equity market.

	Investors that see a valuation opportunity with large-cap biotechs and are willing to bet on that thesis can consider the Market Vectors Biotech ETF (NYSE: <a class="ticker" href="/stock/bbh#NYSE">BBH</a>).

	Related Link:<a href="http://www.benzinga.com/trading-ideas/long-ideas/16/03/7725892/rousseff-is-a-problem-for-brazil-leveraged-etf"> Rousseff Is A Problem For Brazil Leveraged ETF</a>

	&ldquo;The sell-off in biotech stocks that began last summer has resulted in valuations that are on par with and in some cases lower than those seen in the broad equity market (at this writing, 2/17/16). Biotech valuations have not dipped this low since the aftermath of the 2007-2008 financial crisis. For investors with an appetite for biotech, this may provide a bargain-priced opportunity,&rdquo; according to a <a href="http://www.vaneck.com/blogs/big-biotech-in-the-bargain-bin-february-2016/">Market Vectors note</a> published in late February.
<h3>
	Holdings</h3>

	The $506.7 million BBH holds 26 stocks, four of which are the biotech big four: Gilead Sciences, Inc. (NASDAQ: <a class="ticker" href="/stock/gild#NASDAQ">GILD</a>), Amgen, Inc. (NASDAQ: <a class="ticker" href="/stock/amgn#NASDAQ">AMGN</a>), Celgene Corporation (NASDAQ: <a class="ticker" href="/stock/celg#NASDAQ">CELG</a>) and Biogen Inc (NASDAQ: <a class="ticker" href="/stock/biib#NASDAQ">BIIB</a>). Those stocks combine for over 44 percent of BBH&#39;s weight.

	BBH is down 21.7 percent year-to-date, resides 18.8 percent below its 200-day moving average and 31.5 percent below its 52-week high set in July last year. None of those points sound good, but they could be <a href="http://www.benzinga.com/general/biotech/16/02/6230657/rebound-for-big-biotech-etf-will-require-some-patience">confirming the opportunity set with BBH</a>.

	&ldquo;Since 2005 U.S. biotech stocks have traded at higher earnings multiples than the broader S&amp;P 500 Index. Over the last 10 years biotech stocks have had an average price-earnings (P/E) ratio of 23.3 versus 16.2 for the S&amp;P 500 Index. Today those metrics are nearly equivalent in the 16 P/E range,&rdquo; adds Market Vectors.

	There are always potential catalysts looming for biotech stocks and ETFs, namely drug approvals and trials and mergers and acquisitions. This year could bring more of at least one of those two themes.

	&ldquo;The expected total number of upcoming clinical trials, new drug applications, and new biologics up for approval is 32% higher now than five years ago,&rdquo; said Market Vectors.

A Rare Opportunity With A Biotechnology ETF

There are plenty of anecdotes and statistics underscoring how pitifully biotechnology stocks and the relevant exchange-traded funds have performed this year, but this one sums it all up quite nicely: Of the five biotech ETFs that existed prior to 2014, the best performer this year is the Market Vectors Biotech ETF (NASDAQ: <a class="ticker" href="/stock/bbh#NASDAQ">BBH</a>), and that ETF is down 20.1 percent.
That is good enough to put BBH in a bear market less than two months into 2016. Despite the biotech space&#39;s obvious struggles to start 2016, some traders are not shy about expressing bullish views. For example, the iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: <a class="ticker" href="/stock/ibb#NASDAQ">IBB</a>), the largest biotech ETF, has added nearly $81 million in new assets this year.
<bzrelatedlink>Related Link: <a href="http://www.benzinga.com/general/biotech/16/02/6230657/rebound-for-big-biotech-etf-will-require-some-patience">Rebound For Big Biotech ETF Will Require Some Patience</a></bzrelatedlink>
Perhaps surprisingly, <a href="http://www.benzinga.com/general/biotech/16/01/6161734/even-with-volatility-investors-love-biotech-etfs">the ultra-volatile</a> SPDR S&amp;P Biotech (ETF) (NYSE: <a class="ticker" href="/stock/xbi#NYSE">XBI</a>), the third-largest biotech ETF, has lost just $7.2 million in assets.
<h3>Taking A Closer Look At XBI And LABU</h3>
 Speaking of XBI, its leveraged equivalent is on a torrid asset-gathering pace. That ETF is the Direxion Daily S&amp;P Biotech Bull 3X Shares (NYSE: <a class="ticker" href="/stock/labu#NYSE">LABU</a>).
XBI is not for the risk-averse investor. A hallmark of many equal-weight ETFs is a tilt toward smaller stocks not present in cap-weighted funds. XBI&#39;s holdings have a weighted average market capitalization of $9.8 billion. As a result, although XBI has been the best-performing biotech ETF over the past three years, it has also been the most volatile.
Year to date, XBI is down 30 percent, so it would be reasonable to expect that LABU would be down 90 percent. Actually, LABU has been &ldquo;better&rdquo; than that with a year-to-date loss of just under 70 percent. That includes a 10.2 percent tumble Thursday that sent the ETF to a close at $6.42. Low price tags like that for leveraged ETFs can often be harbingers of looming reverse splits. 
None of that has compelled traders to resist LABU&#39;s allure. For the five days ending February 17, LABU&#39;s average volume was 14.2 percent above the trailing 20-day average, <a href="http://www.direxioninvestments.com/wp-content/uploads/2014/03/Direxion-Daily-ETF.pdf?utm_campaign=Daily%20Performance%20Email%20021816&amp;utm_medium=email&amp;utm_source=Eloqua&amp;elqTrackId=d85bb13e50cf40a183773f31e5b78e45&amp;elq=8adedec95bd94796bcdbf2bb7951c805&amp;elqaid=2154&amp;elqat=1&amp;elqCampaignId=1337">according to Direxion data</a>. Over the past 30 days, LABU has averaged daily inflows of nearly $4.8 million.
Year to date, traders have poured $126.5 million into LABU. By comparison, the largest healthcare ETF has bled more than $394 million.
Image Credit: <a href="https://pixabay.com/en/laboratory-beakers-science-1149152/">Public Domain</a>

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