On Tuesday, the U.S. Food and Drug Administration (FDA) placed a clinical hold on Atara Biotherapeutics, Inc.’s ATRA active Investigational New Drug (IND) applications.These INDs include the EBVALLO (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’s lymphoma and systemic lupus erythematosus.Specifically, identified subjects currently enrolled in the cli ...

Levi & Korsinsky Reminds Atara Biotherapeutics, Inc. Investors of the Ongoing Investigation into Potential Violations of Securities Laws – ATRA ...

FDA CRL Impact on Atara Biotherapeutics - Shares of Atara Biotherapeutics (ATRA) plunged 40.5% after the FDA issued a complete response letter (CRL) against the company's biologics license application (BLA) for tabelecleucel (tab-cel) [1] - The CRL was linked to observations from a routine pre-license inspection of a third-party manufacturing facility, with no issues raised regarding manufacturing process, clinical efficacy, or safety data [3] - The FDA did not request additional clinical studies to support Ebvallo's approval [3] Ebvallo's Market and Clinical Data - Tab-cel, marketed as Ebvallo in the EU, is a novel T-cell immunotherapy for EBV+ PTLD, a rare hematologic malignancy with high mortality rates [2] - The BLA submission was based on the pivotal phase III ALLELE study, which showed a statistically significant 50% objective response rate in EBV+ PTLD patients [4] Financial and Operational Implications - The CRL has delayed Ebvallo's U.S. market entry, resulting in lost revenue potential [7] - Atara is eligible for a $60 million milestone payment from Pierre Fabre upon FDA approval, which has also been delayed, impacting operational funding [8] - The company reported preliminary cash, cash equivalents, and short-term investments of approximately $43 million as of Dec 31, 2024 [9] Strategic Alternatives and Funding - Atara is exploring strategic alternatives, including acquisition, merger, reverse merger, or sale of assets, to advance its CAR-T assets [11] - The company has signed a non-binding term sheet with Redmile Group for up to $15 million in equity funding to support Ebvallo BLA approval efforts [10] - If additional funding is not secured by Q1 2025, Atara plans to halt all CAR-T activities and focus solely on Ebvallo's approval [10] Industry Comparison - In the past three months, Atara shares have lost 16.8%, compared to the industry's 12.2% decline [2] - Castle Biosciences (CSTL), CytomX Therapeutics (CTMX), and BioMarin Pharmaceutical (BMRN) are better-ranked stocks in the sector, each sporting a Zacks Rank 1 (Strong Buy) [12] - Castle Biosciences' shares have plunged 23.2% in the past three months, while CytomX Therapeutics and BioMarin Pharmaceutical have lost 28.2% and 12.6%, respectively [13][14][15]

Atara Biotherapeutics (ATRA) is a nimble allogeneic T cell immunotherapy company with several near-term catalysts. This Zacks Rank #2 (Buy) company boasts a pipeline of differentiated therapies across a range of oncology and autoimmune indications from its proven EBV T cell platform.FDA Decision on ATRA's Tab-cel Expected Next WeekThe company’s biologics license application (BLA) seeking approval for its lead product candidate, tabelecleucel (tab-cel), in the United States is under priority review with the ...

Atara Biotherapeutics (ATRA) came out with a quarterly loss of $2.93 per share versus the Zacks Consensus Estimate of a loss of $3.77. This compares to loss of $16.50 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 22.28%. A quarter ago, it was expected that this drug developer would post a loss of $1.25 per share when it actually produced a loss of $3.10, delivering a surprise of -148%.Over the last four quarters, the company ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-36548 ATARA BIOTHERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 46-0920988 (State or Other Jurisdicti ...

Exhibit 99.1 Atara Biotherapeutics Announces Third Quarter 2024 Financial Results and Operational Progress Tab-cel ® U.S. BLA On-Track With PDUFA Target Action Date of January 15, 2025 First Patient Dosed for ATA3219 Non-Hodgkin's Lymphoma Study; Initial Clinical Data Expected Q1 2025 ATA3219 Lupus Nephritis and Extrarenal Systemic Lupus Erythematosus Study Initiation Expected by End of Year; Initial Clinical Data Expected Mid-2025 Cash Runway Into 2027 Enables Key Pipeline Readouts THOUSAND OAKS, Calif.—No ...

Atara Biotherapeutics (ATRA) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.The ...

13 August 2024 | 9:20AM EDT Atara Biotherapeutics Inc. (ATRA): 20 EPS: CEO transition; First CD19 oncology data now in 1025, with autoimmune to follow In tandem with 2Q EPS, ATRA announced a CEO transition in which Cokey Nguyen (ATRA's Chief Scientific and Technical Officer) will succeed Pascal Touchon effective September 9. Further updates included delaying the timing for first Ph1 ATA3219 (allogeneic CD19 CAR T) data in relapsed/refractory B-cell non-Hodgkin's lymphoma to 1Q25 vs. 4Q24 prior on slower pat ...

Atara Biotherapeutics (ATRA) came out with a quarterly loss of $3.10 per share versus the Zacks Consensus Estimate of a loss of $1.25. This compares to loss of $17 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -148%. A quarter ago, it was expected that this drug developer would post a loss of $9.25 per share when it actually produced a loss of $5.75, delivering a surprise of 37.84%.Over the last four quarters, the company ha ...