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Atara Biotherapeutics (NASDAQ:ATRA) Stock, Option Chain

Atara Biotherapeutics

Atara Biotherapeutics Inc operates in the United States healthcare sector. It focuses on developing transformative therapies for patients with serious diseases, including solid tumors, hematologic cancers, and autoimmune diseases. It operates and manages business as one operating and reportable segment which is the business of developing therapeutics. The company's product candidates comprise Tab-cel, ATA188, and ATA3219 (CAR T Platform).

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FDA halts Atara&#39;s EBVALLO and ATA3219 trials over manufacturing issues. Atara eyes $60 million milestone from Pierre Fabre upon EBVALLO approval.

FDA Places Clinical Hold On Atara Biotherapeutics&#39; Two Cell Therapy Programs

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Atara Biotherapeutics, Inc. - Common Stock

Atara Biotherapeutics Inc

On Tuesday, the U.S. Food and Drug Administration (FDA) placed a clinical hold on Atara Biotherapeutics, Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATRA#NASDAQ">ATRA</a>) active Investigational <a target="_blank" href="https://www.benzinga.com/pressreleases/25/01/b43093925/atara-biotherapeutics-provides-update-on-clinical-programs-related-to-ebvallo-tabelecleucel-and-at" rel="noreferrer noopener">New Drug (IND) applications</a>.
These INDs include the EBVALLO&nbsp;(tabelecleucel) program for patients two years of age and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD), as well as ATA3219, a CAR-T therapy for non-Hodgkin&#8217;s lymphoma and systemic lupus erythematosus.
Specifically, identified subjects currently enrolled in the clinical studies who have the potential to derive clinical benefit may continue to receive treatment.
Screening and enrollment of new participants in both programs have been paused.
The clinical hold for EBVALLO is directly linked to inadequately addressed GMP compliance issues identified during the pre-license inspection of the third-party manufacturing facility referenced in the Complete Response Letter (CRL) for EBVALLO that was <a target="_blank" href="https://www.benzinga.com/pressreleases/25/01/b43026975/atara-biotherapeutics-provides-regulatory-and-business-update-on-ebvallotm-tabelecleucel" rel="noreferrer noopener">announced last week</a>.
While the ATA3219 drug product is manufactured at a separate, fully compliant GMP-certified facility, the compliance issues at the same third-party facility referenced in the CRL affect the starting materials used in its production.
These issues, which underlie both the CRL and the clinical hold, are specific to the referenced third-party manufacturing facility and do not affect Atara&#8217;s second third-party manufacturer, FUJIFILM Diosynth Biotechnologies (FDB) facility in Thousand Oaks, California.
The FDB facility remains a critical component of Atara&#8217;s long-term manufacturing strategy for both assets.
Last week, Atara engaged a financial advisor to support the assessment of opportunities to advance and realize value from Atara&#8217;s CAR-T assets.
Atara says it remains eligible to receive a $60 million milestone payment from Pierre Fabre upon FDA approval of the EBVALLO BLA, as well as significant double-digit tiered royalties as a percentage of net sales and milestones related to EBVALLO&#8217;s commercial sales.
The company added that if a strategic resolution is not reached to provide funding for its CAR-T development programs in the first quarter of 2025, Atara plans to suspend all CAR-T activities and significantly reduce company expenses and activities to only those that support the approval of EBVALLO, including through a near-term progressive transfer of all operational activities related to EBVALLO to Pierre Fabre.
Atara has entered into a non-binding term sheet with Redmile Group to provide up to $15 million in funding through an equity line of credit.
Price Action: ATRA stock is down 4.09% at $6.302 at last check Tuesday.
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Photo via Shutterstock.

FDA Places Clinical Hold On Atara Biotherapeutics' Two Cell Therapy Programs

U.S. FDA issues clinical hold on EBVALLO&#x2122; (tabelecleucel) and ATA3219 studies linked to EBVALLO Complete Response Letter (CRL)
<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.atarabio.com%2F&amp;esheet=54183700&amp;newsitemid=20250121045791&amp;lan=en-US&amp;anchor=Atara+Biotherapeutics%2C+Inc.&amp;index=1&amp;md5=c7a54b9aad73e62bc9c74498767d641c">Atara Biotherapeutics, Inc.</a> (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATRA#NASDAQ">ATRA</a>), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on Atara's active Investigational New Drug (IND) applications. These INDs include the EBVALLOTM (tabelecleucel) program as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), as well as ATA3219, an allogeneic CD19-targeted CAR-T therapy, for the treatment of non-Hodgkin's lymphoma and systemic lupus erythematosus. Specifically identified subjects currently enrolled in the clinical studies who have the potential to derive clinical benefit may continue to receive treatment in accordance with the ongoing study protocols. Screening and enrollment of new participants in both programs have been paused.
The clinical hold for EBVALLO is directly linked to inadequately addressed GMP compliance issues identified during the pre-license inspection of the third-party manufacturing facility referenced in the Complete Response Letter (CRL) for EBVALLO that was announced on January 16, 2025. While ATA3219 drug product is manufactured at a separate, fully compliant GMP-certified facility, the starting materials used in its production are affected by the compliance issues at the same third-party facility referenced in the CRL. These issues, which underlie both the CRL and the clinical hold, are specific to the referenced third-party manufacturing facility and do not affect Atara's second third-party manufacturer, FUJIFILM Diosynth Biotechnologies (FDB) facility in Thousand Oaks, California. The FDB facility remains a critical component of Atara's long-term manufacturing strategy for both assets.
Atara and FDA have discussed and agreed upon the actions necessary to release the clinical holds. The FDA has confirmed its commitment to working collaboratively and expeditiously with Atara to resolve the clinical holds.

FDA Places Clinical Hold On Atara Biotherapeutics' EBVALLO And ATA3219 Studies; Linked To Manufacturing Compliance Issues; Enrollment Paused; Existing Subjects May Continue Treatment; Co And FDA Discussed And Agreed Upon Actions For Resolution

Canaccord Genuity analyst John Newman maintains Atara Biotherapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATRA#NASDAQ">ATRA</a>) with a Buy and lowers the price target from $21 to $17.

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Analyst Ratings

Canaccord Genuity Maintains Buy on Atara Biotherapeutics, Lowers Price Target to $17

<h3>Gainers</h3>
<ul>
<li>Biomerica (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BMRA#NASDAQ">BMRA</a>) shares rose 222.8% to $1.13 during Thursday's pre-market session. The market value of their outstanding shares is at $19.0 million. As per the news, the Q2 earnings report came out 2 days ago. </li>
<li>Aditxt (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ADTX#NASDAQ">ADTX</a>) stock moved upwards by 53.51% to $0.2. The company's market cap stands at $2.8 million. </li>
<li>Surrozen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRZN#NASDAQ">SRZN</a>) shares increased by 20.84% to $14.32. The market value of their outstanding shares is at $46.5 million. </li>
<li>Traws Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TRAW#NASDAQ">TRAW</a>) shares increased by 13.78% to $7.8. The company's market cap stands at $23.5 million. </li>
<li>Aclarion (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACON#NASDAQ">ACON</a>) shares moved upwards by 12.0% to $0.05. </li>
<li>Enanta Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ENTA#NASDAQ">ENTA</a>) shares rose 10.05% to $5.3. The company's market cap stands at $112.4 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Atara Biotherapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATRA#NASDAQ">ATRA</a>) stock decreased by 50.5% to $6.52 during Thursday's pre-market session. The market value of their outstanding shares is at $37.5 million. </li>
<li>Silexion Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SLXN#NASDAQ">SLXN</a>) shares fell 21.8% to $1.22. The company's market cap stands at $1.9 million. </li>
<li>GlucoTrack (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GCTK#NASDAQ">GCTK</a>) stock decreased by 14.56% to $0.07. The market value of their outstanding shares is at $1.0 million. </li>
<li>ArriVent BioPharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AVBP#NASDAQ">AVBP</a>) stock fell 11.68% to $22.01. The company's market cap stands at $741.6 million. </li>
<li>Helius Medical Tech (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HSDT#NASDAQ">HSDT</a>) shares fell 10.95% to $0.76. The market value of their outstanding shares is at $2.8 million. </li>
<li>Tenax Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TENX#NASDAQ">TENX</a>) stock fell 10.5% to $5.8. The market value of their outstanding shares is at $19.7 million. 
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</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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12 Health Care Stocks Moving In Thursday's Pre-Market Session

U.S. stocks traded lower toward the end of trading, with the Nasdaq Composite falling over 150 points on Thursday.
The Dow traded down 0.27% to 43,106.65 while the NASDAQ fell 0.79% to 19,356.43. The S&amp;P 500 also fell, dropping, 0.28% to 5,933.22.
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Leading and Lagging Sectors Utilities shares surged by 2.3% on Thursday.
In trading on Thursday, consumer discretionary shares fell by 1.1%.
Top Headline
On Thursday, Morgan Stanley (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MS#NYSE">MS</a>) reported upbeat earnings for its fourth quarter.
The bank posted fourth-quarter adjusted EPS of $2.22, up from $0.85 a year ago and beating the consensus of $1.70. Net earnings more than doubled from $1.52 billion to $3.7 billion.
The U.S. bank reported fourth-quarter revenue of $16.22 billion, up 26% year over year, beating the consensus of $15.03 billion.
Equities Trading UP &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<ul>
<li>Biomerica, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BMRA#NASDAQ">BMRA</a>) shares shot up 102% to $0.6820 after the company announced its Fortel Prostate Specific Antigen Screening Test received approval from the United Arab Emirates Ministry of Health and Prevention.</li>
<li>Shares of DouYu International Holdings Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DOYU#NASDAQ">DOYU</a>)got a boost, surging 26% to $15.53 as the company appointed Simin Ren as Co-CEO and declared a special cash dividend.</li>
<li>Symbotic Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SYM#NASDAQ">SYM</a>) shares were also up, gaining 19% to $31.88 after the company disclosed a deal to acquire Walmart Inc.'s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/WMT#NYSE">WMT</a>) Advanced Systems and Robotics business.</li>
</ul>
Equities Trading DOWN
<ul>
<li>Leafly Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LFLY#NASDAQ">LFLY</a>) shares dropped 45% to $0.8001 after the company announced it received a Nasdaq desliting notice and will transition to the over-the-counter market.</li>
<li>Shares of Atara Biotherapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATRA#NASDAQ">ATRA</a>) were down 34% to $8.70 after the company issued regulatory and business update on EBVALLOTM (tabelecleucel).</li>
<li>Polestar Automotive Holding UK PLC (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PSNY#NASDAQ">PSNY</a>) was down, falling 11% to $1.09 after the company reported preliminary third-quarter revenue of $551 million, down 10% year over year, citing lower volume and competitive market conditions.</li>
</ul>
Commodities In commodity news, oil traded down 1.9% to $78.49 while gold traded up 1.4% at $2,755.10.
Silver traded up 1% to $31.860 on Thursday, while copper rose 1.1% to $4.4350.
Euro zone
European shares closed mostly higher today. The eurozone's STOXX 600 surged 0.98%, Germany's DAX 40 gained 0.39% and France's CAC 40 gained 2.14%. Spain's IBEX 35 Index fell 0.49%, while London's FTSE 100 gained 1.09%.
Asia Pacific Markets
Asian markets closed higher on Thursday, with Japan's Nikkei 225 gaining 0.33%, China's Shanghai Composite Index gaining 0.28%, Hong Kong's Hang Seng Index climbing 1.23% and India's BSE Sensex rising 0.42%.
Economics
<ul>
<li>U.S. retail sales rose 0.4% month-over-month in December versus a revised 0.8% increase in the previous month and down from market estimates of 0.6%.</li>
<li>U.S. initial jobless claims increased by 14,000 from the previous week to 217,000 in the week ending January 11, compared to market estimates of 210,000.</li>
<li>Import prices increased by 0.1% from the previous month in December, while export prices gained by 0.3% in December.</li>
<li>The Philadelphia Fed Manufacturing Index rose to 44.3 in January compared to a revised reading of -10.9 in the previous month.</li>
<li>The NAHB/Wells Fargo Housing Market Index rose to 47 in January compared to 46 in the prior two months.</li>
<li>U.S. business inventories increased by 0.1% month-over-month in November compared to a revised flat reading in the previous month.</li>
<li>U.S. natural-gas stocks fell 258 billion cubic feet during the week ending Jan. 1, the EIA said.</li>
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U.S. stocks traded mixed midway through trading, with the Dow Jones index gaining around 0.1% on Thursday.
The Dow traded up 0.08% to 43,256.69 while the NASDAQ fell 0.17% to 19,478.76. The S&amp;P 500 also rose, gaining, 0.15% to 5,958.69.
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Leading and Lagging Sectors Real estate shares surged by 0.7% on Thursday.
In trading on Thursday, consumer discretionary shares fell by 0.7%.
Top Headline
Bank of America Corp (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BAC#NYSE">BAC</a>) reported better-than-expected fourth-quarter results.
The bank posted quarterly net income of $6.7 billion (versus $3.1 billion a year ago) and EPS of 82 cents, beating the analyst consensus estimate of 77 cents.
Revenue, net of interest expense, increased 15.0% year over year to $25.35 billion, beating the analyst consensus estimate of $25.19 billion.
Equities Trading UP &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<ul>
<li>Biomerica, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BMRA#NASDAQ">BMRA</a>) shares shot up 159% to $0.8763 after the company announced its Fortel Prostate Specific Antigen Screening Test received approval from the United Arab Emirates Ministry of Health and Prevention.</li>
<li>Shares of DouYu International Holdings Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DOYU#NASDAQ">DOYU</a>)got a boost, surging 26% to $15.50 as the company appointed Simin Ren as Co-CEO and declared a special cash dividend.</li>
<li>Sezzle Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SEZL#NASDAQ">SEZL</a>) shares were also up, gaining 14% to $296.00 after the company announced it expects to exceed its previously provided 2024 revenue and income guidance.</li>
</ul>
Equities Trading DOWN
<ul>
<li>Leafly Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LFLY#NASDAQ">LFLY</a>) shares dropped 44% to $0.82 after the company announced it received a Nasdaq desliting notice and will transition to the over-the-counter market.</li>
<li>Shares of Atara Biotherapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATRA#NASDAQ">ATRA</a>) were down 45% to $7.16 after the company issued regulatory and business update on EBVALLOTM (tabelecleucel).</li>
<li>Polestar Automotive Holding UK PLC (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PSNY#NASDAQ">PSNY</a>) was down, falling 13% to $1.0592 after the company reported preliminary third-quarter revenue of $551 million, down 10% year over year, citing lower volume and competitive market conditions.</li>
</ul>
Commodities In commodity news, oil traded down 1% to $79.24 while gold traded up 1% at $2,743.60.
Silver traded up 0.5% to $31.690 on Thursday, while copper rose 1% to $4.4330.
Euro zone
European shares were mostly higher today. The eurozone's STOXX 600 surged 0.63%, Germany's DAX 40 gained 0.13% and France's CAC 40 gained 1.83%. Spain's IBEX 35 Index fell 0.54%, while London's FTSE 100 gained 0.82%.
Asia Pacific Markets
Asian markets closed higher on Thursday, with Japan's Nikkei 225 gaining 0.33%, China's Shanghai Composite Index gaining 0.28%, Hong Kong's Hang Seng Index climbing 1.23% and India's BSE Sensex rising 0.42%.
Economics
<ul>
<li>U.S. retail sales rose 0.4% month-over-month in December versus a revised 0.8% increase in the previous month and down from market estimates of 0.6%.</li>
<li>U.S. initial jobless claims increased by 14,000 from the previous week to 217,000 in the week ending January 11, compared to market estimates of 210,000.</li>
<li>Import prices increased by 0.1% from the previous month in December, while export prices gained by 0.3% in December.</li>
<li>The Philadelphia Fed Manufacturing Index rose to 44.3 in January compared to a revised reading of -10.9 in the previous month.</li>
<li>The NAHB/Wells Fargo Housing Market Index rose to 47 in January compared to 46 in the prior two months.</li>
<li>U.S. business inventories increased by 0.1% month-over-month in November compared to a revised flat reading in the previous month.</li>
</ul>
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U.S. stocks traded slightly lower this morning, with the Dow Jones index falling around 0.2% on Thursday.
Following the market opening Thursday, the Dow traded down 0.19% to 43,137.38 while the NASDAQ fell 0.11% to 19,489.02. The S&amp;P 500 also fell, dropping, 0.03% to 5,947.83.
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Leading and Lagging Sectors Utilities shares surged by 0.8% on Thursday.
In trading on Thursday, consumer discretionary shares fell by 0.6%.
Top Headline
U.S. retail sales rose 0.4% month-over-month in December versus a revised 0.8% increase in the previous month and down from market estimates of 0.6%.
Equities Trading UP &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<ul>
<li>Biomerica, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BMRA#NASDAQ">BMRA</a>) shares shot up 246% to $1.1700 after the company announced its Fortel Prostate Specific Antigen Screening Test received approval from the United Arab Emirates Ministry of Health and Prevention.</li>
<li>Shares of Wheeler Real Estate Investment Trust, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/WHLR#NASDAQ">WHLR</a>)got a boost, surging 50% to $3.5204.</li>
<li>DatChat, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DATS#NASDAQ">DATS</a>) shares were also up, gaining 45% to $6.18.</li>
</ul>
Equities Trading DOWN
<ul>
<li>Leafly Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LFLY#NASDAQ">LFLY</a>) shares dropped 48% to $0.7592 after the company announced it received a Nasdaq desliting notice and will transition to the over-the-counter market.</li>
<li>Shares of Atara Biotherapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATRA#NASDAQ">ATRA</a>) were down 45% to $7.22 after the company issued regulatory and business update on EBVALLOTM (tabelecleucel).</li>
<li>LuxUrban Hotels Inc. &nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LUXH#NASDAQ">LUXH</a>) was down, falling 44% to $0.3825. LuxUrban Hotels recently issued FY25 revenue guidance.</li>
</ul>
Commodities In commodity news, oil traded down 0.6% to $79.58 while gold traded up 1.1% at $2,748.40.
Silver traded up 0.8% to $31.785 on Thursday, while copper rose 0.6% to $4.4155.
Euro zone
European shares were mostly higher today. The eurozone's STOXX 600 surged 0.9%, Germany's DAX 40 gained 0.4% and France's CAC 40 gained 2.1%. Spain's IBEX 35 Index fell 0.1%, while London's FTSE 100 gained 1%.
Asia Pacific Markets
Asian markets closed higher on Thursday, with Japan's Nikkei 225 gaining 0.33%, China's Shanghai Composite Index gaining 0.28%, Hong Kong's Hang Seng Index climbing 1.23% and India's BSE Sensex rising 0.42%.
Economics
<ul>
<li>U.S. retail sales rose 0.4% month-over-month in December versus a revised 0.8% increase in the previous month and down from market estimates of 0.6%.</li>
<li>U.S. initial jobless claims increased by 14,000 from the previous week to 217,000 in the week ending January 11, compared to market estimates of 210,000.</li>
<li>Import prices increased by 0.1% from the previous month in December, while export prices gained by 0.3% in December.</li>
<li>The Philadelphia Fed Manufacturing Index rose to 44.3 in January compared to a revised reading of -10.9 in the previous month.</li>
</ul>
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Atara received FDA Complete Response Letter (CRL) solely related to inspection findings at third-party manufacturer
CRL did not identify deficiencies related to clinical efficacy or safety data in the Biologics License Application (BLA), and the FDA did not request any new clinical studies to support approval
Atara remains committed to working with the FDA, Pierre Fabre Laboratories, and the third-party manufacturer to bring EBVALLO to patients in the U.S.
Atara has engaged a well-known financial advisor to support exploration of all strategic options
Atara remains focused on preserving future EBVALLO financial value for the benefit of all stockholders
Atara has entered into a non-binding term sheet with Redmile Group to provide up to $15 million in funding, which Atara believes is sufficient to fund the ongoing activities required to achieve BLA approval
<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.atarabio.com%2F&amp;esheet=54181246&amp;newsitemid=20250116967931&amp;lan=en-US&amp;anchor=Atara+Biotherapeutics%2C+Inc.&amp;index=1&amp;md5=9226b8c5857f17efdf6e9037fd00fdcd">Atara Biotherapeutics, Inc.</a> (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATRA#NASDAQ">ATRA</a>), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the EBVALLOTM (tabelecleucel) Biologics License Application (BLA) as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), who have received at least one prior therapy including an anti-CD20 containing regimen.
The CRL was solely related to observations as part of a standard pre-license inspection of a third-party manufacturing facility for EBVALLO. The CRL did not identify any deficiencies related to the manufacturing process, the clinical efficacy, or clinical safety data in the BLA, and the FDA did not request any new clinical trials to support the approval of EBVALLO.

Atara Receives FDA CRL Citing Third-Party Manufacturer Inspection For EBVALLO; No Clinical Deficiencies Noted; $15M Funding Secured From Redmile Group To Support BLA Approval Efforts; Engages In Strategic Options Exploration With Financial Advisor; Focus On Preserving Future Value

Trading Halt: Halted at 8:25:00 a.m. ET - Trading Halt: Halt News Pending

<h3>Gainers</h3>
<ul>
<li>P3 Health Partners (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PIII#NASDAQ">PIII</a>) shares increased by 43.8% to $0.31 during Tuesday's pre-market session. The company's market cap stands at $50.3 million. </li>
<li>Immuron (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IMRN#NASDAQ">IMRN</a>) stock increased by 22.33% to $2.41. The market value of their outstanding shares is at $13.7 million. </li>
<li>Co-Diagnostics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CODX#NASDAQ">CODX</a>) shares rose 21.12% to $0.92. The market value of their outstanding shares is at $29.4 million. </li>
<li>Regenxbio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RGNX#NASDAQ">RGNX</a>) stock rose 17.26% to $8.15. The company's market cap stands at $403.7 million. </li>
<li>Atara Biotherapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATRA#NASDAQ">ATRA</a>) stock rose 15.44% to $18.69. The market value of their outstanding shares is at $107.6 million. </li>
<li>Abpro Hldgs (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABP#NASDAQ">ABP</a>) stock increased by 12.3% to $1.46. The market value of their outstanding shares is at $75.6 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Phio Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PHIO#NASDAQ">PHIO</a>) shares declined by 42.7% to $3.78 during Tuesday's pre-market session. The company's market cap stands at $6.5 million. </li>
<li>Avinger (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AVGR#NASDAQ">AVGR</a>) shares fell 21.56% to $0.63. The company's market cap stands at $2.0 million. </li>
<li>Agape ATP (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATPC#NASDAQ">ATPC</a>) shares fell 21.32% to $1.55. The company's market cap stands at $6.1 million. </li>
<li>Salarius Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SLRX#NASDAQ">SLRX</a>) stock decreased by 21.26% to $2.89. The market value of their outstanding shares is at $4.1 million. </li>
<li>Anitra (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/AZTR#AMEX">AZTR</a>) shares decreased by 14.8% to $0.49. The market value of their outstanding shares is at $3.7 million. </li>
<li>GT Biopharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GTBP#NASDAQ">GTBP</a>) shares decreased by 12.98% to $2.08. The market value of their outstanding shares is at $4.6 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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12 Health Care Stocks Moving In Tuesday's Pre-Market Session

Rodman &amp; Renshaw analyst Tony Butler initiates coverage on Atara Biotherapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATRA#NASDAQ">ATRA</a>) with a Buy rating and announces Price Target of $25.

Initiation

Rodman & Renshaw Initiates Coverage On Atara Biotherapeutics with Buy Rating, Announces Price Target of $25

WIIM

Atara Biotherapeutics shares are trading higher after the company reported better-than-expected Q3 sales results. Also, Canaccord Genuity maintained a Buy rating on the stock and raised its price target from $13 to $21.

Canaccord Genuity analyst John Newman maintains Atara Biotherapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATRA#NASDAQ">ATRA</a>) with a Buy and raises the price target from $13 to $21.

Canaccord Genuity Maintains Buy on Atara Biotherapeutics, Raises Price Target to $21

Atara Biotherapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATRA#NASDAQ">ATRA</a>) reported quarterly losses of $(2.93) per share which missed the analyst consensus estimate of $(2.50) by 17.2 percent. The company reported quarterly sales of $40.190 million which beat the analyst consensus estimate of $35.168 million by 14.28 percent. This is a 1.78K percent increase over sales of $2.138 million the same period last year.

Earnings Beats

Earnings Misses

Atara Biotherapeutics Q3 2024 GAAP EPS $(2.93) Misses $(2.50) Estimate, Sales $40.190M Beat $35.168M Estimate

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Avadel Pharmaceuticals plc - American Depositary Shares each representing one Ordinary Share

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The Beachbody Company, Inc. Class A Common Stock

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Earnings Scheduled For November 12, 2024

Atara Biotherapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATRA#NASDAQ">ATRA</a>) is gearing up to announce its quarterly earnings on Tuesday, 2024-11-12. Here's a quick overview of what investors should know before the release.
Analysts are estimating that Atara Biotherapeutics will report an earnings per share (EPS) of $-1.93.
Atara Biotherapeutics bulls will hope to hear the company announce they've not only beaten that estimate, but also to provide positive guidance, or forecasted growth, for the next quarter.
New investors should note that it is sometimes not an earnings beat or miss that most affects the price of a stock, but the guidance (or forecast).
<h3>Performance in Previous Earnings</h3>
The company's EPS missed by $1.54 in the last quarter, leading to a 3.22% increase in the share price on the following day.
Here's a look at Atara Biotherapeutics's past performance and the resulting price change:

<table>
<thead>
<tr>
<th>Quarter</th>
<th>Q2 2024</th>
<th>Q1 2024</th>
<th>Q4 2023</th>
<th>Q3 2023</th>
</tr>
</thead>
<tbody>
<tr>
<td>EPS Estimate</td>
<td>-1.56</td>
<td>-6.50</td>
<td>-12</td>
<td>-16.5</td>
</tr>
<tr>
<td>EPS Actual</td>
<td>-3.10</td>
<td>-5.75</td>
<td>-14</td>
<td>-16.5</td>
</tr>
<tr>
<td>Price Change %</td>
<td>3.0%</td>
<td>-3.0%</td>
<td>-1.0%</td>
<td>-6.0%</td>
</tr>
</tbody>
</table>

<img src="https://www.benzinga.com/files/images/story/2024/1731348105_0.png" alt="eps graph" />
<h3>Tracking Atara Biotherapeutics's Stock Performance</h3>
Shares of Atara Biotherapeutics were trading at $11.31 as of November 08. Over the last 52-week period, shares are up 41.23%. Given that these returns are generally positive, long-term shareholders should be satisfied going into this earnings release. 
<a href="https://www.benzinga.com/quote/ATRA/earnings">To track all earnings releases for Atara Biotherapeutics visit their earnings calendar on our site.</a>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Insights into Atara Biotherapeutics's Upcoming Earnings

Hyllengren's Base Salary Increased To $520,000 Annually; No Related Person Transactions Or Arrangements Involved In Promotion

Management

Atara Biotherapeutics Appoints Eric Hyllengren As Chief Operating Officer In Addition To His Role As Chief Financial Officer

U.S. stocks traded mixed midway through trading, with the Nasdaq Composite gaining around 0.2% on Wednesday.
The Dow traded down 0.08% to 40,906.17 while the NASDAQ rose 0.21% to 17,172.66. The S&amp;P 500 also fell, dropping, 0.03% to 5,527.51.
Check This Out:<a href="https://www.benzinga.com/trading-ideas/long-ideas/24/09/40706790/top-3-consumer-stocks-that-could-blast-off-this-quarter"> Top 3 Consumer Stocks That Could Blast Off This Quarter</a>
Leading and Lagging Sectors Utilities shares climbed by 0.6% on Wednesday.
In trading on Wednesday, energy shares fell by 0.9%.
Top Headline
Shares of Dollar Tree, Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DLTR#NASDAQ">DLTR</a>) dipped over 21% on Wednesday after the company reported worse-than-expected second-quarter 2024 earnings.
The discount variety stores chain reported an adjusted EPS of 67 cents, missing the consensus of $1.04, and down 26.4% year over year. The company reported sales of $7.38 billion, up marginally by 0.07%, missing the consensus of $7.5 billion.
Equities Trading UP &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<ul>
<li>Faraday Future Intelligent Electric Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FFIE#NASDAQ">FFIE</a>) shares shot up 43% to $4.8986.</li>
<li>Shares of Atara Biotherapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATRA#NASDAQ">ATRA</a>) got a boost, surging 32% to $9.00. The company announced a $36 million registered direct offering of 758,900 shares at $8.25 per share.</li>
<li>WiSA Technologies, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/WISA#NASDAQ">WISA</a>) shares were also up, gaining 69% to $2.30 after the company announced that it executed a definitive asset purchase agreement to purchase the Datavault intellectual property and information technology assets of privately held Data Vault Holdings for $210 million.</li>
</ul>
Equities Trading DOWN
<ul>
<li>Athira Pharma, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATHA#NASDAQ">ATHA</a>) shares dropped 78% to $0.6361 after the company released topline results from its Phase 2/3 LIFT-AD clinical trial of fosgonimeton for mild-to-moderate Alzheimer's disease (AD).</li>
<li>Shares of Oragenics, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/OGEN#NYSE">OGEN</a>) were down 45% to $0.59. Oragenics priced its $4.45 million public offering of 8,106,584 shares at $0.55 per share.</li>
<li>Psyence Biomedical Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PBM#NASDAQ">PBM</a>) was down, falling 33% to $0.2482. The company announced it entered into a worldwide, exclusive royalty-bearing IP licensing agreement with PsyLabs.</li>
</ul>
Commodities In commodity news, oil traded down 1% to $69.68 while gold traded up 0.2% at $2,527.20.
Silver traded up 0.9% to $28.595 on Wednesday, while copper fell 0.3% to $4.0805.
Euro zone
European shares were lower today. The eurozone's STOXX 600 fell 0.97%, Germany's DAX fell 0.83% and France's CAC 40 fell 0.98%. Spain's IBEX 35 Index fell 0.58%, while London's FTSE 100 fell 0.35%.
The S&amp;P Global UK services PMI climbed to 53.7 in August from 52.5 in the prior month. Producer prices in the Eurozone rose 0.8% month-over-month in July versus a revised 0.6% increase in June. The HCOB Eurozone composite PMI was revised lower to 51 in August versus a flash reading of 51.2.
Asia Pacific Markets
Asian markets closed lower on Wednesday, with Japan's Nikkei 225 falling 4.24%, Hong Kong's Hang Seng Index falling 1.10%, China's Shanghai Composite Index declining 0.67% and India's BSE Sensex falling 0.25%.
The HSBC India Composite PMI rose to 60.7 in August versus a flash reading of 60.5. Caixin China General Composite PMI came in unchanged at 51.2 in August.
Economics
The trade deficit in the U.S. increased to $78.8 billion in July, recording the biggest gap since June 2022, versus a gap of $73 billion in June.
Now Read This: 
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<li><a href="https://www.benzinga.com/news/24/09/40708182/wall-streets-most-accurate-analysts-weigh-in-on-3-energy-stocks-with-over-7-dividend-yields">Wall Street&#8217;s Most Accurate Analysts Weigh In On 3 Energy Stocks With Over 7% Dividend Yields</a></li>
</ul>

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Crude Oil Down 1%; Dollar Tree Shares Tumble After Downbeat Earnings

Atara Biotherapeutics Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATRA#NASDAQ">ATRA</a>) shares are trading higher by 30.7% to $8.87 Wednesday morning. The company announced a $36 million registered direct offering of 758,900 shares at <a href="https://www.benzinga.com/pressreleases/24/09/b40695909/atara-biotherapeutics-announces-36-million-registered-direct-offering">$8.25 per share.</a>
The offering, priced at a 15% premium to the company&#8217;s recent average stock price, involves the sale of 758,900 shares at $8.25 per share and 3,604,780 pre-funded warrants at $8.2499 per share. The pre-funded warrants are almost immediately exercisable.&nbsp;
The investors include Redmile Group, EcoR1 Capital, Adiumentum Capital Management and a large public biotech company. The offering is expected to close around September 5.
Additionally, Greg Ciongoli, founder of Adiumentum Capital, will join Atara&#8217;s Board of Directors. The funds will be used for working capital and general corporate purposes.
Read Also: <a href="https://www.benzinga.com/markets/equities/24/09/40696921/traders-bet-aggressively-on-rate-cuts-ahead-of-jobs-data-5-etfs-to-watch-this-week">Traders Bet Aggressively On Rate Cuts Ahead Of Jobs Data: 5 ETFs To Watch This Week</a>
<h2 class="wp-block-heading">How To Buy ATRA Stock</h2>
Besides going to a brokerage platform to purchase a share &#8211; or fractional share &#8211; of stock, you can also gain access to shares either by buying an exchange traded fund (ETF) that holds the stock itself, or by allocating yourself to a strategy in your 401(k) that would seek to acquire shares in a mutual fund or other instrument. 
For example, in Atara Biotherapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATRA#NASDAQ">ATRA</a>)'s case, it is in the Health Care sector. An ETF will likely hold shares in many liquid and large companies that help track that sector, allowing an investor to gain exposure to the trends within that segment.
According to data from&nbsp;<a href="https://benzinga.grsm.io/register174">Benzinga Pro</a>, ATRA has a 52-week high of $49.00 and a 52-week low of $4.96.

Atara Biotherapeutics (ATRA) Stock Is Up 20%: What's Going On?

Shares of GitLab Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GTLB#NASDAQ">GTLB</a>) rose sharply in today's pre-market trading after the company reported better-than-expected second-quarter financial results and issued <a href="https://www.benzinga.com/news/earnings/24/09/40696793/gitlab-stock-climbs-on-q2-results-strong-fy-25-guidance">FY25 guidance above estimates.</a>
GitLab reported quarterly earnings of 15 cents per share, which beat the analyst consensus estimate by 50%. Quarterly revenue came in at $182.6 million, which beat the analyst consensus estimate of $176.889 million by 3.23%.
GitLab shares jumped 16.8% to $52.21 in the pre-market trading.
Here are some other stocks moving in pre-market trading.
<h3 class="wp-block-heading">Gainers</h3>
<ul>
<li>WiSA Technologies, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/WISA#NASDAQ">WISA</a>) gained 63.2% to $2.22 in pre-market trading as the company said it has executed a definitive asset purchase agreement to purchase the Datavault&#xAE; intellectual property and information technology assets of privately held Data Vault Holdings Inc.</li>
<li>Conifer Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CNFR#NASDAQ">CNFR</a>) rose 39.1% to $1.60 in today's pre-market trading. Conifer Holdings shares jumped 74% on Tuesday after the company announced that it completed the sale of its insurance agency operations for a $45 million consideration. The company appointed Brian Roney As CEO.</li>
<li>LogicMark, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LGMK#NASDAQ">LGMK</a>) gained 29.4% to $0.2618 in pre-market trading after gaining over 12% on Monday.</li>
<li>Atara Biotherapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATRA#NASDAQ">ATRA</a>) gained 17.2% to $7.99 in pre-market trading. The company announced a $36 million registered direct offering of 758900 shares at $8.25 per share.</li>
<li>Tantech Holdings Ltd (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TANH#NASDAQ">TANH</a>) gained 16% to $0.1613 in the pre-market trading session.</li>
<li>BTCS Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BTCS#NASDAQ">BTCS</a>) gained 10% to $1.10 in pre-market trading after dipping around 15% on Tuesday.</li>
<li>Genelux Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GNLX#NASDAQ">GNLX</a>) rose 9.1% to $2.27 in pre-market trading after declining around 4% on Tuesday.</li>
<li>Clover Health Investments, Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CLOV#NASDAQ">CLOV</a>) gained 8.4% to $2.71 in pre-market trading after subsidiary Iowa Clinic signed a multi-year agreement with Counterpart Health to deploy AI technology across hundreds of Midwest providers.</li>
<li>Astera Labs, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALAB#NASDAQ">ALAB</a>) gained 4% to $40.66 in pre-market trading after dipping 9% on Tuesday.</li>
</ul>
<h3 class="wp-block-heading">Losers</h3>
<ul>
<li>Athira Pharma, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATHA#NASDAQ">ATHA</a>) fell 72.7% to $0.7739 in pre-market trading after the company announced its Phase 2/3 LIFT-AD clinical trial for Fosgonimeton in mild-to-moderate Alzheimer&#8217;s disease did not meet its primary or key secondary endpoints.</li>
<li>Oragenics, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/OGEN#NYSE">OGEN</a>) shares fell 32.2% to $0.7254 in pre-market trading after dipping more than 15% on Tuesday. Oragenics, last month, announced the filing completion for its ONP-002 drug in anticipation of its Phase IIa clinical trail in concussed patients.</li>
<li>Focus Universal Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FCUV#NASDAQ">FCUV</a>) shares fell 16.4% to $0.2530 in pre-market trading after gaining more than 12% on Tuesday.</li>
<li>Shuttle Pharmaceuticals Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SHPH#NASDAQ">SHPH</a>) shares declined 16.2% to $1.76 in pre-market trading. The company was granted #12077515 for selective histone deacetylase inhibitors.</li>
<li>Zscaler, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ZS#NASDAQ">ZS</a>) fell 15.2% to $163.70 in pre-market trading following fourth-quarter earnings.</li>
<li>Asana, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ASAN#NYSE">ASAN</a>) shares declined 14.6% to $11.35 in pre-market trading. Asana reported upbeat results for its second quarter but issued weak guidance for the third quarter.</li>
<li>PagerDuty, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PD#NYSE">PD</a>) fell 14.4% to $15.66 in today's pre-market trading. PagerDuty reported better-than-expected earnings for its second quarter, while sales missed estimates.</li>
<li>Elevai Labs Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ELAB#NASDAQ">ELAB</a>) shares fell 11.3% to $0.2839 in pre-market trading. Elevai Labs shares gained around 20% on Tuesday after its subsidiary, Elevai Skincare, announced data results that demonstrated the potential of its proprietary Elevai Exosomes in hair restoration.</li>
<li>Motorsport Games Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MSGM#NASDAQ">MSGM</a>) shares dipped 11.3% to $1.16 in pre-market trading after gaining 10% on Tuesday.</li>
<li>Sify Technologies Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SIFY#NASDAQ">SIFY</a>) declined 9.6% to $0.5971 in pre-market trading after jumping around 100% on Tuesday.</li>
</ul>
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</ul>

Pre-Market Outlook

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TANH

Why GitLab Shares Are Trading Higher By Around 17%; Here Are 20 Stocks Moving Premarket

Atara Biotherapeutics (ATRA) announced it received a complete response letter from the FDA for the Ebvallo biologics license application as monothe...

Atara announces Ebvallo CRL did not find clinical efficacy deficiencies

Atara had previously engaged a financial advisor to support the assessment of opportunities to advance and realize value from Atara's CAR-T assets....

Atara Biotherapeutics expands review of strategic alternatives for CAR-T assets

Atara down 46% as FDA declines to approve organ, bone marrow transplant therapy

Analyst John Newman of Canaccord Genuity maintained a Buy rating on Atara Biotherapeutics (ATRA – Research Report), reducing the price target to $1...

Buy Rating for Atara Biotherapeutics Driven by Manufacturing Resolution and Strategic Initiatives

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