Latest news for Oncopeptides (OTC:ONPPF) Stock

Oncopeptides AB is a biotech company focused on the research, development, and commercialization of therapies for difficult-to-treat hematological diseases. The company uses its proprietary Peptide Drug Conjugate (PDC) to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. It has focused on the development of the product candidate Melflufen (Pepaxti), a peptide-conjugated alkylator, belonging to a new class of drugs called Peptidase Enhanced Compounds. Melflufen is intended as an effective treatment for hematological cancers and in particular multiple myeloma.

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Following a mixed month for regulatory approvals, biotech investors now turn toward a month of plenty as far as Food and Drug Administration decisions are concerned.

Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates

After Second Look Oncopeptides&#39; Melflufen Wins Head-To-Head Myeloma Trial, But Difference In OS Triggers FDA Hold

Oncopeptides AB

Amid growing economic concerns, analysts are sounding alarms over the potential <a href="https://www.benzinga.com/24/11/42178994/trump-says-he-will-impose-25-tariffs-on-canada-mexico-on-first-day-of-office-and-extra-tariffs-on-china-until-they-pay-attention">repercussions of tariffs </a>proposed by the incoming Trump administration. These tariffs, aimed at addressing trade imbalances, could inadvertently lead to a stronger dollar, affecting consumers and businesses alike.
Tariffs Could Hurt Customers
Adam Posen, president of the&nbsp;Peterson Institute for International Economics, highlighted that Trump&#8217;s economic strategies, including tariffs and tax cuts, are likely to elevate the dollar&#8217;s value during <a href="https://www.cnbc.com/video/2024/11/28/most-of-trumps-economic-plans-will-push-up-dollar-us-think-tank.html">CNBC&#8217;s</a> &#8220;Squawk Box Asia&#8221;&nbsp;on Thursday. This could result in a minimal reduction in the trade deficit, despite efforts to decrease it.
While it is unclear how these tariffs will affect the prices of goods, many companies are seeing signs of waning demand among buyers, the WSJ <a href="https://www.wsj.com/business/retail/trump-tariffs-warnings-retailer-sales-fc270ca9">reported</a> on Friday. Companies like Jolie Skin, and Home Furnishings are urging customers to buy their products before a possible hike in their prices once the tariffs kick in.
Earlier in October, billionaire investor&nbsp;Mark Cuban&nbsp;and Barack Obama-era Treasury Secretary&nbsp;Lawrence Summers warned that <a href="https://www.benzinga.com/markets/equities/24/10/41568486/mark-cuban-highlights-trumps-potential-to-ruin-christmas-but-he-might-also-end-up-spoiling-the-p">tariffs proposed by Trump</a>&nbsp;could significantly increase the cost of <a href="https://www.benzinga.com/news/24/10/41590247/trumps-trade-proposals-could-play-the-role-of-the-grinch-warns-obama-era-treasury-secretary-larry-su">Christmas holiday shopping</a> for American families.
See Also:&nbsp;<a href="https://www.benzinga.com/24/11/42206056/bitcoin-ethereum-dogecoin-tumble-as-diamond-hands-lock-in-gains-analyst-anticipates-strong-buyback-pressure-to-follow-sell-pressure?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">Bitcoin, Ethereum, Dogecoin Tumble As &#8216;Diamond Hands&#8217; Lock In Gains: Top Analyst Anticipates BTC Rebound</a>
Corie Barry, CEO of&nbsp;Best Buy Co. Inc., warned that the burden of tariffs would likely translate into higher consumer prices, as <a href="https://fortune.com/2024/11/27/ceos-warning-trump-tariffs-will-raise-prices-for-consumers-best-buy/">reported</a> by the Fortune.
Jesper Brodin, CEO of&nbsp;Ingka Group, which owns&nbsp;Ikea, echoed the sentiments while talking to <a href="https://edition.cnn.com/2024/11/27/business/ikea-prices-trump-tariffs-intl/index.html">CNN </a>and mentioned that high tariffs have historically not been beneficial, complicating efforts to keep prices low for consumers. 
"Tariffs make it more difficult for us to maintain the low prices and be affordable for many people, which in the end is our goal," Brodin said.
Trump recently declared his intention to impose a <a href="https://www.benzinga.com/government/regulations/24/11/42213610/hasbro-best-buy-brace-as-trumps-tariffs-loom-could-retail-margins-hit-rock-bottom">25% tariff on goods</a> from Mexico and Canada, citing border security concerns. He also announced additional tariffs on Chinese imports to address the flow of fentanyl into the U.S.&nbsp;
Stronger Dollar Might Not Help That Much With Deficit
Commodities like oil, timber, and metals are often priced in U.S. dollars. When the dollar strengthens, these goods become more expensive in other currencies. As a result, the rising costs of energy and raw materials contribute to higher prices for a wide range of products, driving inflation worldwide.
A stronger domestic currency &#8211; in this case, the U.S. dollar &#8211; usually helps in making imports cheaper and exports more expensive, assuming other conditions remain the same. However, in some cases, suppliers and sellers might pass on some of the increase in their input costs to the buyer &#8211; in this case, their customers in the U.S.
Even so, Posen says a stronger dollar could still not prove to be enough to help bridge the trade deficit.
&#8220;The main point is that even if you push up tariffs and you are trying to reduce the trade deficit, when you do so you tend to push up the dollar,&#8221; said Posen.
&#8220;If you cut taxes and you don&#8217;t fund it fully with other other revenues or other spending cuts, you tend to push up the dollar. If you are busy creating global uncertainty, which is a stated strategic tool of this incoming administration, you tend to push up the dollar.&#8221;
Read Next:&nbsp;
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<li><a href="https://www.benzinga.com/markets/cryptocurrency/24/11/42196217/will-gamestop-amc-follow-microstrategy-rumble-into-bitcoin?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">Will GameStop, AMC Follow MicroStrategy, Rumble Into Bitcoin?</a></li>
</ul>
Disclaimer: This content was partially produced with the help of&nbsp;<a href="https://www.benzinga.com/author/benzinga-neuro" target="_blank" rel="noreferrer noopener">Benzinga Neuro</a>&nbsp;and was reviewed and published by Benzinga editors.
Photo: Anna Moneymaker via Shutterstock

Analyst Color

Macro Economic Events

Economics

Markets

Trump Tariffs Could Hit Pockets Of Consumers, Retailers Urge Customers To Shore Up Purchases: Experts Warn A Stronger Dollar Might Still Not Make Up For Deficit

Advanced Micro Devices Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMD#NASDAQ">AMD</a>) could emerge as a more attractive investment option compared to Nvidia Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVDA#NASDAQ">NVDA</a>) as <a href="https://www.benzinga.com/24/11/42227834/cathie-wood-buys-amazon-amd-stock-trims-palantir-block-holdings-amid-ai-and-bitcoin-euphoria">the artificial intelligence chip market evolves</a>, according to a new analysis from Trefis Team released Wednesday.
What Happened: While Nvidia has dominated the AI chip market with its stock surging 180% this year to reach a market capitalization of $3.5 trillion, its premium valuation of 48 times projected fiscal 2025 earnings could limit future gains. AMD, trading at a more modest 28 times forward earnings, offers investors exposure to AI growth at a more reasonable entry point.
The analysis highlights several factors potentially working in AMD&#8217;s favor. A key shift is occurring in the AI market from model training to inference &#8211; the process of generating outputs from trained models. AMD&#8217;s MI300X chip has demonstrated strong performance in inference tasks, competing effectively with Nvidia&#8217;s H100 GPU according to MLCommons benchmark testing.
This competitive position is translating into significant business opportunities. IBM (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IBM#NYSE">IBM</a>) recently announced plans to offer AMD&#8217;s MI300X AI processors on its cloud services in the first half of 2025, signaling growing market acceptance.
See Also: <a href="https://www.benzinga.com/trading-ideas/movers/24/11/42237636/bitcoin-ethereum-dogecoin-simmer-down-on-thanksgiving-analyst-sees-significant-shift-from-btc-season-to-alt-season">Bitcoin, Ethereum, Dogecoin Simmer Down On Thanksgiving: Analyst Sees &#8216;Significant Shift&#8217; From BTC Season To Alt Season</a>
Why It Matters: Cost considerations are also becoming increasingly important for customers. With Nvidia&#8217;s GPUs priced above $25,000 each, companies are seeking more affordable alternatives. Oracle Corp&#8216;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ORCL#NYSE">ORCL</a>) recent selection of AMD chips for its AI supercluster, citing strong performance at competitive prices, exemplifies this trend.
AMD&#8217;s financial performance supports the positive outlook. The company&#8217;s data center segment <a href="https://www.benzinga.com/news/earnings/24/10/41612007/amd-q3-earnings-revenue-beat-eps-in-line-data-center-up-122-significant-growth-opportunities-ahead-">reported $3.5 billion in third-quarter sales</a>, marking a 118% increase year-over-year. 
&#8220;While the AI revolution is possibly just getting started, investors will need to pick the right winners to continue profiting from this trend,&#8221; noted the Trefis analysis. &#8220;Specifically, we think it might be time to reconsider Nvidia stock and look closely at AMD.&#8221;
The stock has shown significant volatility, with annual returns ranging from -55% in 2022 to 128% in 2023, but has delivered overall gains of 1,112% since 2017, substantially outperforming the S&amp;P 500&#8217;s 167% return over the same period.
Trefis&#8217;s High-Quality portfolio, comprising 30 stocks, has outperformed the S&amp;P 500, growing a $100,000 investment to over $190,000 since its launch in September 2020.
According to <a href="https://www.benzinga.com/quote/AMD/analyst-ratings">Benzinga Pro data</a>, AMD has a consensus price target of $195.77, with the highest target at $265 and the lowest at $145. Recent analyst ratings from Benchmark, Citigroup, and TD Cowen suggest an almost 43% upside from the current price.
<figure class="wp-block-image size-large"><img decoding="async" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/11/29032556/Screenshot-2024-11-29-at-1.54.13%E2%80%AFPM-1024x377.png" alt="" class="wp-image-669623" /></figure>
Read Next: 
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<li><a href="https://www.benzinga.com/news/global/24/11/42238773/cathie-wood-sees-tesla-as-largest-ai-project-on-earth-heres-why-shes-not-worried-about-tech-investments">Cathie Wood Sees Tesla As &#8216;Largest AI Project On Earth&#8217; — Here&#8217;s Why She&#8217;s Not Worried About Tech Investments</a></li>
</ul>
Image Via Shutterstock 
Disclaimer:&nbsp;This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

Equities

Analyst Ratings

NVDA

ORCL

AMD Stock Could Trump Nvidia As AI Chip Market Evolves, Says Analyst: 'Time To Reconsider' The Right Winners To 'Continue Profiting'

Donald Trump&#8216;s second administration is under the microscope for potential conflicts of interest due to the business ties of several cabinet nominees. Ethics experts are sounding alarms over the implications of appointing wealthy business figures to key government positions.
What Happened: Concerns are mounting that these appointments could blur the lines between&nbsp;business interests and government policy, the&nbsp;Financial Times <a href="https://www.ft.com/content/be99aeda-24f1-4b3f-9eaa-c62b7025773c">reported</a> on Friday. 
See Also:&nbsp;<a href="https://www.benzinga.com/general/education/24/11/42204590/trump-department-of-homeland-security-pick-kristi-noem-owns-ranch-invests-in-energy-gets-book-royalties?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">Trump Department Of Homeland Security Pick Kristi Noem Owns Ranch, Invests In Energy, Gets Book Royalties</a>
Trump&#8217;s cabinet, potentially the wealthiest in history, includes nominees like hedge fund manager&nbsp;Scott Bessent&nbsp;for Treasury Secretary,&nbsp;Cantor Fitzgerald&nbsp;CEO Howard Lutnick&nbsp;for Commerce Secretary, and&nbsp;Liberty Energy CEO Chris Wright&nbsp;for Energy Secretary. Tesla CEO Elon Musk is also a close adviser to the president-elect. 
Critics argue that the intersection of business and government in Trump&#8217;s administration could be more complicated than in previous administrations, potentially undermining government ethics standards. 
Walter Shaub, the former head of the Office of Government Ethics, a federal agency, said, "We are looking at potentially the greatest ethics cataclysm in the history of our government.&#8221;
Why It Matters: The formation of the Department of Government Efficiency, led by&nbsp;Musk&nbsp;and&nbsp;Vivek Ramaswamy, has been criticized by Clinton-era official&nbsp;Robert Reich&nbsp;as potentially being <a href="https://www.benzinga.com/politics/24/11/41962372/trumps-doge-with-musk-at-the-helm-riddled-with-conflicts-of-interest-says-clinton-era-official-robert-reich">&#8220;riddled with conflicts of interest.&#8221;</a> Reich expressed skepticism about the department&#8217;s true purpose, suggesting it might serve as a &#8220;quid-pro-quo&#8221; arrangement.
Meanwhile, Trump&#8217;s pick for U.S. Treasury Secretary Bessent is known <a href="https://www.benzinga.com/government/regulations/24/11/42150805/trump-picks-hedge-fund-exec-scott-bessent-as-treasury-secretary-what-president-elects-choice-means-for-americas-economic-future">for his support of gradual tariffs</a> and deregulation, aligning with Trump's economic vision, which includes reviving manufacturing and achieving energy independence. Despite Musk's support for Howard Lutnick, <a href="https://www.benzinga.com/etfs/24/11/42044642/trump-appears-frustrated-as-elon-musk-chimes-in-on-treasury-secretary-adds-more-names-to-a-list-of-potential-picks" target="_blank" rel="noreferrer noopener">Trump favored Bessent's</a> business-as-usual approach.
Read Next:&nbsp;
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<li><a href="https://www.benzinga.com/general/education/24/11/42171604/trumps-department-of-education-secretary-pick-linda-mcmahon-owns-tko-stock-thanks-to-famous-wrestling-past?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">Trump&#8217;s Department Of Education Secretary Pick Linda McMahon Owns TKO Stock Thanks To Famous Wrestling Past</a></li>
</ul>
Image via Flickr
This story was generated using <a href="https://www.benzinga.com/author/benzinga-neuro">Benzinga Neuro</a> and edited by <a href="https://www.benzinga.com/topic/Pooja-Rajkumari" target="_blank" rel="noreferrer noopener">Pooja Rajkumari</a>

Politics

Media

Trump White House Picks, Including Elon Musk And Scott Bessent, Spark Conflict Of Interest Concerns: 'Potentially The Greatest Ethics Cataclysm In The History Of Our Government'

Operational Highlights
<ul>
<li>Total number of stores on group level&nbsp;was 7,420&nbsp;as of September 30, 2024, an increase of 859&nbsp;net new stores in the first nine months of 2024.</li>
<li>Number of&nbsp;MINISO stores&nbsp;was 7,186&nbsp;as of September 30, 2024, an increase of 773 net new stores in the first nine months of 2024.</li>
</ul>
-Number of MINISO stores in mainland China was&nbsp;4,250&nbsp;as of September 30, 2024, a net increase of 324&nbsp;in the first nine months of 2024, compared to 3,926 as of December 31, 2023.
-Number of MINISO stores in overseas markets was 2,936&nbsp;as of September 30, 2024, a net increase of&nbsp;449&nbsp;in the first nine months of 2024, compared to 2,487 as of December 31, 2023.
<ul>
<li>Number of TOP TOY stores was 234&nbsp;as of September 30, 2024, with a record opening of 86&nbsp;net new stores in the first nine months of 2024.</li>
</ul>

MNSO

MINISO'S Total Number Of Stores On Group Level Was 7,420 As Of September 30, 2024, An Increase Of 859 Net New Stores In The First Nine Months Of 2024

MINISO Group Holding (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MNSO#NYSE">MNSO</a>) reported quarterly earnings of RMB2.20 per share which missed the analyst consensus estimate of RMB2.21 by 0.45 percent. This is a 7.84 percent increase over earnings of RMB2.04 per share from the same period last year. The company reported quarterly sales of RMB4.522 billion which missed the analyst consensus estimate of RMB4.609 billion by 1.88 percent. This is a 19.28 percent increase over sales of RMB3.791 billion the same period last year.

Earnings

Earnings Misses

MINISO Group Holding Q1 2025 Adj. EPS RMB2.20 Misses RMB2.21 Estimate, Sales RMB4.522B Miss RMB4.609B Estimate

GPRK

GeoPark Inks Binding Agreement To Acquire Repsol's 45% Stake In CPO-9 And 25% In Llanos Norte Oil Projects In Colombia

Through this acquisition, we will expand our maintenance business in Norway and further strengthen our business foundation by promoting a strategy aimed at increasing our elevator maintenance stock in the European market, where we anticipate continued growth in demand for maintenance and renewal.

MIELY

Mitsubishi Electric Enhances European Elevator And Escalator Business Through Acquisition Of ALT Heis

<h3>Companies Reporting Before The Bell</h3>
• MINISO Group Holding (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MNSO#NYSE">MNSO</a>) is likely to report quarterly earnings at $0.33 per share on revenue of $659.09 million. 
<h3>Companies Reporting After The Bell</h3>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Earnings Scheduled For November 29, 2024

<ul>
<li>Wearable robot 'X-ble Shoulder' to boost industrial efficiency and reduce musculoskeletal injuries</li>
<li>Designed to assist overhead work by enhancing upper arm muscle strength, expected to find use in various industries</li>
<li>The strong yet lightweight X-ble Shoulder enhances worker comfort by reducing shoulder load by 60% and muscle activity by 30%</li>
<li>Hyundai Motor and Kia's Robotics LAB announced commercialization plan for X-ble Shoulder, expected to begin deliveries in first half of 2025</li>
</ul>

HYMTF

Reported Wednesday, Hyundai And Kia To Debut 'X-ble Shoulder' In 2025, Cutting Muscle Activity And Enhancing Worker Comfort For Overhead Tasks

EVTV

Reported Wednesday, Envirotech Vehicles Delivers Electric Vans To FedEx Partners, Promising Cost Savings And Zero Emissions

Econ #s

France Harmonised Index of Consumer Prices (MoM) Preliminary For November -0.1% Vs. 0.0% Est.; 0.3% Prior

France Gross Domestic Product (QoQ) For Q3 0.4% Vs. 0.4% Est.; 0.2% Prior

France Gross Domestic Product (YoY) For Q3 1.2% Vs. 1.3% Est.; 1.0% Prior

France Consumer Price Index (MoM) Preliminary For -0.1% Vs. 0.0% Est.; 0.2% Prior

France Consumer Spending (MoM) For September -0.4% Vs. -0.1% Est.; 0.1% Prior

Tesla Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NASDAQ">TSLA</a>) has introduced a major enhancement to its <a href="https://www.benzinga.com/topic/optimus">humanoid robot, Optimus</a>, featuring new hands.
What Happened: This announcement aligns with Neuralink&#8216;s recent FDA approval for its CONVOY Study. This trial will let Neuralink test its Brain-to-Computer (BCI) implant with assistive robotic arms – such as those of the Optimus bot.
This development follows Neuralink&#8217;s announcement of FDA approval for its CONVOY study, which will test the Brain-to-Computer-interface (BCI) N1 Implant with assistive robotic arms.
During a Neuralink update in July, Musk suggested that Optimus limbs could potentially work alongside the N1 implant. Neuralink also plans to allow participants to enroll in both the CONVOY and PRIME studies, the latter having already enabled two patients to control devices with their minds.
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<blockquote class="twitter-tweet" data-width="500" data-dnt="true">We're excited to announce the approval and launch of a new feasibility trial to extend BCI control using the N1 Implant to an investigational assistive robotic arm. This is an important first step towards restoring not only digital freedom, but also physical freedom. More info…
&mdash; Neuralink (@neuralink) <a href="https://twitter.com/neuralink/status/1861107594645119006?ref_src=twsrc%5Etfw">November 25, 2024</a></blockquote>
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The latest update from Tesla Optimus humorously stated, &#8220;Got&nbsp;a new hand for Black&nbsp;Friday,&#8221; showcasing the robot&#8217;s capability to catch&nbsp;a tennis ball with its&nbsp;upgraded hand.
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<blockquote class="twitter-tweet" data-width="500" data-dnt="true">Got a new hand for Black Friday <a href="https://t.co/x3gQrsbYAQ">pic.twitter.com/x3gQrsbYAQ</a>
&mdash; Tesla Optimus (@Tesla_Optimus) <a href="https://twitter.com/Tesla_Optimus/status/1862116407594377698?ref_src=twsrc%5Etfw">November 28, 2024</a></blockquote>
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In May,&nbsp;CEO Elon Musk&nbsp;indicated plans to enhance Optimus&#8217; hands to achieve 22 degrees of freedom, nearing the 27 degrees found in human hands.
See Also: <a href="https://www.benzinga.com/tech/24/11/42230503/tesla-cybercab-spotted-testing-in-giga-texas-facility">Tesla Cybercab Spotted Testing In Giga Texas Facility</a>
Why It Matters: The unveiling of the new hand upgrade for Tesla&#8217;s Optimus robot comes at a time when the company is making strides in autonomous navigation and interaction capabilities.
In October, Tesla showcased Optimus&#8217; ability to autonomously navigate a factory, avoid obstacles, and <a href="https://www.benzinga.com/news/24/10/41376564/tesla-showcases-optimus-autonomous-navigation-charging-abilities-after-admitting-they-were-human-ass">interact with humans</a> by handing over snacks and drinks upon request.
Moreover, Musk&nbsp;recently <a href="https://www.benzinga.com/tech/24/11/41834327/elon-musk-reveals-toughest-part-of-building-teslas-humanoid-robot-improving-the-design-of-optimus-for-ease-of-manufacturing">acknowledged the challenges</a> in refining Optimus&#8217; design for easier manufacturing and establishing a complex supply chain for mass production. Despite these hurdles, Musk remains optimistic about the long-term economic potential of humanoid robots driven by artificial general intelligence.
In a related development, <a href="https://www.benzinga.com/24/11/42159490/elon-musks-tesla-hunts-top-talent-to-develop-software-for-robotaxi-optimus-robot-teleoperation-2">Tesla is actively seeking top talent</a> to enhance software for the teleoperation of its robotaxis and Optimus robots. This initiative aims to develop low-latency, reliable data streaming solutions for real-world applications.
Price Action: Tesla stock closed at $332.89 on Wednesday, down 1.6% for the day. In after-hours trading, the stock increased slightly by 0.5%. Year to date, Tesla's stock has gained 34%, according to&nbsp;<a href="https://pro.benzinga.com/dashboard" target="_blank" rel="noreferrer noopener">data from Benzinga Pro</a>.
Analysts have a consensus rating of "Neutral" on the Tesla stock, according to Benzinga Pro data. The highest price target is $400, while the consensus price target is 232.20, implying a 30% downside.
Check out more of Benzinga's Future Of Mobility coverage by&nbsp;<a href="https://www.benzinga.com/topic/mobility" target="_blank" rel="noreferrer noopener">following this link.</a>
Read Next:
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<li><a href="https://www.benzinga.com/tech/24/11/42183055/elon-musk-slams-californias-proposal-to-shut-tesla-evs-out-of-consumer-rebates-in-state-this-is-insane?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">Elon Musk Slams California&#8217;s Proposal To Shut Tesla EVs Out Of Consumer Rebates In State: &#8216;This Is Insane'</a></li>
</ul>
Disclaimer:&nbsp;This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Photo courtesy: Tesla

Tech

TSLA

Tesla's Optimus Bot Gets New Hands As Neuralink's FDA-Approved BCI Trials Begin

Major U.S. indices have advanced between 18% to 27% year-to-date. The S&amp;P 500 Index scaled its 52nd record high this year on Tuesday, Nov. 26. Bulls and Bears are locking horns as S&amp;P 500 is on track to deliver 20% plus year-to-date gains for the second time.
What Happened: Markets have been under pressure only once in the month of December over the last 95 years, according to the data highlighted by Ryan Detrick, chief market strategist at Carson Group LLC.
Thanksgiving falls on the fourth Thursday of November every year, addressing the next month of December, Detrick shared the data and said &#8220;Something to be thankful for?&#8221;, in an X (formerly Twitter). The data from 1928 to 2023 showed that September has been the worst 13 times while April is the worst month this year with a 4% drop.
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<blockquote class="twitter-tweet" data-width="500" data-dnt="true">Something to be thankful for? December has been the worst month of the year for stocks only once going back 95 years (2018 and the Fed policy mistake). Worst month this year has been the 4% drop in April. <a href="https://t.co/2ThL3DwD7x">pic.twitter.com/2ThL3DwD7x</a>
&mdash; Ryan Detrick, CMT (@RyanDetrick) <a href="https://twitter.com/RyanDetrick/status/1862188406505185730?ref_src=twsrc%5Etfw">November 28, 2024</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>
</figure>
Also read: <a href="http://GOP Megadonor Ken Griffin Slashes Citadel's Palantir Stake By 91%, Bets Big On Nvidia As Jensen Huang-Led Company Rises Over 180% In 2024">GOP Megadonor Ken Griffin Slashes Citadel&#8217;s Palantir Stake By 91%, Bets Big On Nvidia As Jensen Huang-Led Company Rises Over 180% In 2024</a>
On the other hand, David Cox, CMT, CFA, portfolio manager at Raymond James Ltd., in an X Post highlighted the likelihood of an upcoming to the investors, saying &#8220;If you want to sidestep a decline, watch the trend…&#8221;
The 13/34-week Exponential Moving Average signals a bullish market trend when the 13-week EMA line is above the 34-week EMA line and a bullish crossover results in a market correction. Predicting an upcoming crossover through his chart Cox said that &#8220;there will be another red circle some day&#8221;, The red circle in his chart represents a bullish crossover.
According to a <a href="https://www.cmgwealth.com/ri/how-i-think-about-the-13-34-week-exponential-moving-average/">note by CMGWealth</a>, the 13/34-week EMA analysis is a &#8220;simple, tactical trend indicator that has historically captured the cyclical bull and bear market trends.&#8221;
<figure class="wp-block-embed is-type-rich is-provider-twitter wp-block-embed-twitter"> 
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<blockquote class="twitter-tweet" data-width="500" data-dnt="true">again, look at how much easier we can make it on ourselves&#8230; time frame matters, if you want to sidestep a decline, watch the trend&#8230; look at these 13/34-week EMA <a href="https://twitter.com/hashtag/bearish?src=hash&amp;ref_src=twsrc%5Etfw">#bearish</a> crossovers&#8230; they help you remove emotion, and stay focused&#8230; there will be another red circle some day <a href="https://t.co/kpAXx8F5jX">pic.twitter.com/kpAXx8F5jX</a>
&mdash; David Cox, CMT, CFA (@DavidCoxRJ) <a href="https://twitter.com/DavidCoxRJ/status/1861758050215891069?ref_src=twsrc%5Etfw">November 27, 2024</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>
</figure>
Why It Matters: Markets have been trading higher than their pre-election levels and the expectations of a further 25 basis point rate cut in December rose to just 66.3%, according to <a href="https://www.cmegroup.com/markets/interest-rates/cme-fedwatch-tool.html">CME Group&#8217;s FedWatch tool</a>. This indicates a further upside in the stock markets.
The S&amp;P 500 index has risen 26.48% year-to-date to basis. Whereas, the Nasdaq 100, Dow Jones, and Russell 200 Index have returned 25.39%, 18.58%, and 20.54%, respectively. The SPDR S&amp;P 500 ETF Trust (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SPY#NYSE">SPY</a>) was up by 26.7% and the Invesco QQQ ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/QQQ#NYSE">QQQ</a>) advanced by 23.39%, according to Benzinga Pro data.
Read next: <a href="https://www.benzinga.com/general/market-summary/24/11/42206673/trumps-running-mate-vice-president-pick-and-venture-capitalist-jd-vance-holds-etfs-bitcoin-and-more-here-is-a-look-at-his-portfolio" target="_blank" rel="noreferrer noopener">JD Vance&#8217;s Investment Playbook Has Bitcoin And ETFs: Here&#8217;s What Else The VP-Elect Is Betting On</a>

Wall Street's December Surprise: What Investors Need to Know Now

BIIB

ESAIY

Reported Wednesday, Eisai and Biogen Introduce LEQEMBI In South Korea To Combat Alzheimer's And Mild Cognitive Impairment

Reported Wednesday, KKR And Weave Living Strengthen Partnership With $3,000+ Unit Residential Program In Japan

ZLAB

Reported Wednesday, Zai Lab Announces AUGTYRO Inclusion For ROS1+ NSCLC In China's Updated National Reimbursement Drug List

Oncopeptides

Following a mixed month for regulatory approvals, biotech investors now turn toward a month of plenty as far as Food and Drug Administration decisions are concerned.

Four new molecular entities, or NMEs, were approved in September. Seagen Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SGEN#NASDAQ">SGEN</a>) and Genmab&#39;s&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GMAB#NASDAQ">GMAB</a>)&nbsp;antibody-drug conjugate Tivdak for the treatment of metastatic cervical cancer and Takeda Pharmaceutical&#39;s&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TAK#NYSE">TAK</a>)&nbsp;Exkivity for the treatment of EGFR exon 20 insertion&ndash;positive non&ndash;small cell lung cancer were among the NME approvals for the month.

Incyte Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/INCY#NASDAQ">INCY</a>) <a href="https://www.benzinga.com/general/biotech/21/09/23057229/back-to-back-fda-approval-for-incyte-this-time-for-jakafi-in-gvhd">received</a> twin regulatory nods this month.

On the other hand, Calliditas Therapeutics AB (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CALT#NASDAQ">CALT</a>) was in for a disappointment as the drug regulator <a href="https://www.benzinga.com/general/biotech/21/09/22946435/calliditas-therapeutics-stock-falls-as-fda-pushes-nefecon-pdufa-goal-date-to-december">announced</a> a three-month extension in the review period for its Nefecon as a treatment option for primary IgA Nephropathy.

Verrica Pharmaceuticals Inc.&#39;s&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VRCA#NASDAQ">VRCA</a>)&nbsp;viral skin infection treatment candidate was rejected by the FDA.

Here are the key PDUFA catalysts for the unfolding month.

Click&nbsp;<a href="https://www.benzinga.com/fda-biotech#historical">here&nbsp;</a>to access&nbsp;Benzinga&#39;s FDA Calendar

<h3>Gilead Eyes Additional Approval For Tecartus In Severe Leukemia Patients</h3>

<ul>
	<li>Company: Gilead Sciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>)</li>
	<li>Type of Application: supplemental biologic license application</li>
	<li>Candidate: Tecartus</li>
	<li>Indication: blood cancer</li>
	<li>Date: Oct. 1</li>
</ul>

Tecartus (brexucabtagene autoleucel) is a CAR T-cell therapy that&#39;s being evaluated in adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Gilead acquired the asset through its Kite acquisition. It&#39;s currently indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.

<h3>Can Chemocentryx&#39;s Avacopan Find a Smooth Sailing Following An Extended Review?</h3>

<ul>
	<li>Company: ChemoCentryx, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CCXI#NASDAQ">CCXI</a>)</li>
	<li>Type of Application: new drug application</li>
	<li>Candidate: avacopan</li>
	<li>Indication: ANCA-Associated Vasculitis</li>
	<li>Date: Oct. 7</li>
</ul>

Avacopan is an orally-administered small molecule that employs a targeted mode of action in the treatment of ANCA-associated vasculitis and other complement-driven autoimmune and inflammatory diseases.

ANCA-associated vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This leads to organ damage and failure, mainly the kidney, and is fatal if not treated.

The FDA accepted the avacopan NDA for review on Sept. 17, 2020, and set an original PDUFA goal date of July 7. An FDA panel that reviewed the NDA in early May issued a split verdict. The regulator finally extended the review period by three months.

<h3>Avadel Hopes To Take Its Sleep Disorder Drug Past The Finish Line</h3>

<ul>
	<li>Company: Avadel Pharmaceuticals plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AVDL#NASDAQ">AVDL</a>)</li>
	<li>Type of Application: NDA</li>
	<li>Candidate: FT218</li>
	<li>Indication: sleep disorder</li>
	<li>Date: Oct. 15</li>
</ul>

FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.

If approved, FT218 will be the first and only once-nightly oxybate medication, a significant advancement to the twice-nightly regimen that has been required for nearly 20 years, the company had said in a statement.

FT218 will be approved by the PDUFA date, and its sales can grow to over $300 million&nbsp;in 2023, and generate sales in the $400 million+ range in the outer years on a non-risk-adjusted basis given its more convenient once-nightly dosing vs other sodium oxybates, Needham analyst Ami Fadia said in a recent note.

<h3>&lsquo;No&#39; Or &lsquo;No-go&#39; For United Therapeutics&#39; Dry Powder Formulation Of Pulmonary Arterial Hypertension Drug?</h3>

<ul>
	<li>Company: United Therapeutics Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/UTHR#NASDAQ">UTHR</a>)</li>
	<li>Type of Application: NDA</li>
	<li>Candidate: Tyvaso DPI (inhaled treprostinil)</li>
	<li>Indication: Pulmonary arterial hypertension</li>
	<li>Date: Oct. 15</li>
</ul>

United Therapeutics is developing Tyvaso DPI under a collaboration and license agreement with MannKind Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNKD#NASDAQ">MNKD</a>).

Tyvaso DPI incorporates the dry powder formulation technology and Dreamboat inhalation device technology used in MannKind&#39;s Afrezza inhalation powder product, which was approved by the FDA in 2014. If approved, Tyvaso DPI is expected to provide a more convenient method of administration as compared with traditional nebulized Tyvaso therapy.

<h3>Oyster Point Pharma Awaits Nod For Dry Eye Disease Drug</h3>

<ul>
	<li>Company: Oyster Point Pharma, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OYST#NASDAQ">OYST</a>)</li>
	<li>Type of Application: NDA</li>
	<li>Candidate: OC-01 (varenicline) nasal spray</li>
	<li>Indication: dry eye disease</li>
	<li>Date: Oct. 17</li>
</ul>

OC-01 nasal spray is a highly selective cholinergic agonist being developed as a multi-dose preservative-free nasal spray to treat the signs and symptoms of dry eye disease. Dry eye disease, a chronic, progressive condition that impacts more than 30 million people in the U.S., is a multifactorial condition of the ocular surface characterized by disruption of the tear film.

Dry eye disease affects quality of life, as it can cause persistent stinging, scratching, burning sensations, sensitivity to light, blurred vision and eye fatigue.

The NDA was accepted for review on March 2, with a decision-by date of Oct. 17. The company is planning a U.S. launch in the fourth quarter, contingent on FDA approval.

Related Link: <a href="https://www.benzinga.com/general/biotech/21/09/23174252/why-moderna-is-investing-in-a-new-science-center">Why Moderna Is Investing In A New Science Center</a>

<h3>Omeros Hopes For No Further Hiccups In Narsoplimab Approval</h3>

<ul>
	<li>Company: Omeros Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMER#NASDAQ">OMER</a>)</li>
	<li>Type of Application: BLA</li>
	<li>Candidate: narsoplimab</li>
	<li>Indication: hematopoietic stem cell transplant-associated thrombotic microangiopathy</li>
	<li>Date: Oct. 17</li>
</ul>

Omeros&#39; narsoplimab is its lead MASP-2 inhibitor that targets the lectin pathway of complement. It&#39;s also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19.

Transplant-associated thrombotic microangiopathy is an endothelial damage syndrome that is increasingly identified as a complication of both autologous and allogeneic hematopoietic cell transplantation in children.

The original PDUFA date of July 17 was extended by three months due to the additional time sought by the FDA to review information provided by the company in response to a request by the agency.

<h3>Ocular Seeks Label Expansion For Dextenza</h3>

<ul>
	<li>Company: Ocular Therapeutix, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OCUL#NASDAQ">OCUL</a>)</li>
	<li>Type of Application: sNDA</li>
	<li>Candidate: Dextenza</li>
	<li>Indication: allergic conjunctivitis</li>
	<li>Date: Oct. 18</li>
</ul>

Dextenza is being evaluated for the treatment of ocular itching associated with allergic conjunctivitis. It was previously approved for the treatment of ocular inflammation and pain following ophthalmic surgery.

It&#39;s a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the lower eyelid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives.

<h3>Will Sanofi-Regeneron&#39;s Dupixent Get Another Label Expansion?</h3>

<ul>
	<li>Company: Sanofi (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) &amp; Regeneron Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>)</li>
	<li>Type of Application: sBLA</li>
	<li>Candidate: Dupixent</li>
	<li>Indication: asthma in children</li>
	<li>Date: Oct. 21</li>
</ul>

Dupixent is being evaluated as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Dupixent is currently approved as an add-on treatment for patients with uncontrolled moderate-to-severe asthma aged 12 and older with elevated eosinophils or oral corticosteroid dependent asthma.

<h3>Roche Has a Date With FDA For Its Novel Therapeutic For Retinal Disorder</h3>

<ul>
	<li>Company: Roche Holding AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>)</li>
	<li>Type of Application: BLA</li>
	<li>Candidate: Port Delivery System with ranibizumab, or PDS</li>
	<li>Indication: neovascular or wet age-related macular degeneration</li>
	<li>Date: Oct. 23</li>
</ul>

PDS is a permanent refillable eye implant designed to continuously deliver a customized formulation of ranibizumab over a period of months, potentially reducing the treatment burden associated with frequent eye injections.

If approved, PDS, according to the company, would be a first-of-its-kind therapeutic approach, offering people living with nAMD an alternative to frequent eye injections of anti-vascular endothelial growth factor, the current standard of care.

<h3>Eyenovia&#39;s Pupil Dilation Agent Up Before FDA Altar</h3>

<ul>
	<li>Company: Eyenovia, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EYEN#NASDAQ">EYEN</a>)</li>
	<li>Type of Application: NDA</li>
	<li>Candidate: MydCombi</li>
	<li>Indication: Pupil dilation agent for eye examination</li>
	<li>Date: Oct. 28</li>
</ul>

MydCombi is a fixed combination pupil dilation agent for potential use in eye exams. Eyenovia noted that if approved, MydCombi would be the first microdosed ocular therapeutic applied with a high precision smart delivery system, the Optejet.

<h3>Can Second Time Be Charm For ANI Pharma?</h3>

<ul>
	<li>Company: ANI Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ANIP#NASDAQ">ANIP</a>)</li>
	<li>Type of Application: sNDA</li>
	<li>Candidate: purified Cortrophin gel</li>
	<li>Indication: multiple indications</li>
	<li>Date: Oct. 29</li>
</ul>

Purified Cortrophin gel is a purified adrenocorticotropic hormone previously approved in the U.S. for multiple indications including multiple sclerosis, rheumatoid arthritis, and nephrotic syndrome.

The FDA originally approved Cortrophin Gel in 1954 for the treatment of several autoimmune conditions. The usage of the therapy was discontinued in the 1980s. ANI Pharma acquired it from Merck &amp; Co. Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) in early 2016 and worked on validating the therapy and modernizing its manufacturing and control processes to align with current FDA standards.

The original regulatory application submitted by ANI Pharma was rejected by the FDA in April 2020 due to concerns with the quality of information provided about the therapy&#39;s chemistry, manufacturing, and control processes. Following the company&#39;s resubmission, the FDA accepted it for review in late August.

<h3>Can Clearside Biomedical &amp; Bausch Succeed In Second Try For Macular Edema Drug?</h3>

<ul>
	<li>Company: Clearside Biomedical, Inc. ((NASDAQ: LSD) &amp; Bausch Health Companies Inc. (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BHC#OTC">BHC</a>)</li>
	<li>Type of Application: NDA</li>
	<li>Candidate: Xipere (triamcinolone acetonide)</li>
	<li>Indication: macular edema associated with uveitis.</li>
	<li>Date: Oct. 30</li>
</ul>

Xipere is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the suprachoroidal space that is being investigated for the treatment of macular edema associated with uveitis.

The initial NDA submitted by the duo was issued a complete response letter in Oct. 2019, and a resubmission of the application was done in early May. The FDA accepted the resubmitted application in early June and deemed it as a Class 2 resubmission.

<h3>Adcom Calendar</h3>

FDA&#39;s Antimicrobial Drugs Advisory Committee will discuss Takeda&#39;s NDA for maribavir oral tablets for the treatment of adults with post-transplant cytomegalovirus infection and/or disease, including infections resistant. The meeting is scheduled to be held Oct. 7, between 9 a.m. and 5 p.m.

The Oncologic Drugs Advisory Committee is scheduled to deliberate on Oncopeptides AB (OTC:<a class="ticker" href="https://www.benzinga.com/stock/ONPPF#OTC">ONPPF</a>)&#39;s NDA for Pepaxto (melphalan flufenamide) for injection, in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. The meeting will be held Oct. 28, between 10:30 a.m. and 3 pm.

<ul>
	<li>Oncopeptides AB&nbsp;(OTC:<a class="ticker" href="https://www.benzinga.com/stock/ONPPF#OTC">ONPPF</a>) has some good news and some bad news&nbsp;<a class="editor-rtfLink" href="https://www.prnewswire.com/news-releases/updated-results-from-phase-3-ocean-study-shows-melflufen-met-primary-endpoint-of-superior-pfs--overall-survival-data-lead-to-partial-clinical-hold-301327653.html" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">from the updated results from Phase 3 OCEAN study</a>&nbsp;of Pepaxto (melflufen) plus dexamethasone in patients with relapsed / refractory multiple myeloma who have received 2 &ndash; 4 prior lines of therapy.</li>
	<li>The good news is that while preparing the clinical study report and regulatory documents, Oncopeptides discovered that the independent review committee lacked access to all the information in the clinical database.</li>
	<li>The discovery led to the blinded reassessment of the full 495-patient database by the independent review committee.</li>
	<li>In the final analysis, melflufen met the primary endpoint of superior Progression-Free Survival (PFS) compared to&nbsp;Bristol-Myers Squibb Co&rsquo;s&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) Pomalyst (pomalidomide) among patients with drug-resistant multiple myeloma.</li>
	<li>Data from 29 patients had to be reassessed, and the p-value on the primary slid from 0.0640 to 0.0311.</li>
	<li>The bad news is that the overall survival (OS) hazard ratio (HR) was 1.104 in favor of Pomalyst.</li>
	<li>Oncopeptides believes its survival results are &ldquo;primarily explained by substantial HR differences between pre-specified subgroups in both directions.</li>
	<li>The FDA has slapped a partial clinical hold on all trials involving the drug.</li>
	<li>Price Action:&nbsp;The company shares tanked 22.5% to SEK74.8 on the Stockholm Stock Exchange in afternoon trading in reaction to clinical hold.</li>
</ul>

After Second Look Oncopeptides' Melflufen Wins Head-To-Head Myeloma Trial, But Difference In OS Triggers FDA Hold

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