Atara's Ebvallo and pipeline candidate put on clinical hold in US after partner's failed plant inspection
After receiving a complete response letter last week, the other shoe has dropped for Atara Biotherapeutics and its pipeline of T-cell immunotherapies. | Atara announced that the FDA has placed a clinical hold on the company’s investigational new drug applications for the Europe-approved Ebvallo and the allogeneic CD19-targeted CAR-T candidate ATA3219.
Atara Biotherapeutics reports clinical hold placed on Ebvallo programs, ATA3219
Atara Biotherapeutics (ATRA) announced that the FDA has placed a clinical hold on Atara’s active investigational new drug, or IND,
Stifel cuts Atara Biotherapeutics target to $5, holds rating
Stifel analysts adjusted their outlook on Atara Biotherapeutics (NASDAQ:ATRA) stock, reducing the price target to $5 from the previous $10, while maintaining a Hold rating on the shares. The decision follows an announcement from Atara that the FDA has placed clinical holds on two of its therapies,
Atara Biotherapeutics Shares Plunge 38% Following FDA Response to EBVALLO Application
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FDA Places Clinical Hold On Atara Biotherapeutics' Two Cell Therapy Programs
On Tuesday, the U.S. Food and Drug Administration (FDA) placed a clinical hold on Atara Biotherapeutics, Inc.’s (NASDAQ: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),
Atara extends losses after FDA clinical hold
Shares of Atara Biotherapeutics (NASDAQ:ATRA) continued to trade lower in the premarket on Tuesday after the U.S. Food and Drug Administration (FDA) slapped the cell therapy developer with a clinical hold,
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Atara’s T cell programmes hit with clinical hold after third-party site woes
The FDA placed a clinical hold on two Atara assets, following an inspection at a third-party site that also led to a CRL for ...
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Atara, Pierre Fabre hit a hurdle with Ebvallo in the US courtesy of manufacturing plant's shortfalls
As partners Atara Biotherapeutics and Pierre Fabre Laboratories work to grow the reach of their novel T-cell immunotherapy ...
Atara Biotherapeutics Provides Update on Clinical Programs Related to EBVALLO™ (tabelecleucel) and ATA3219
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr ...
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FDA Presses Pause on Atara’s Programs, Play on Amylyx’s ALS Assets
The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a ...
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Atara Biotherapeutics: Another Dip Buying Opportunity Following CRL For CMC Issues
Atara has just announced a CRL by FDA for EBVALLO. EBVALLO is already approved in Europe since December 2022 and the cause of the CRL seems minor and easily addressable. The CRL has a major impact ...
Atara announces Ebvallo CRL did not find clinical efficacy deficiencies
Atara Biotherapeutics (ATRA) announced it received a complete response letter from the FDA for the Ebvallo biologics license application as ...
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Manufacturing Issues Result in FDA Rejection of Atara’s Cell Therapy
Atara Therapeutics’ Ebvallo, already marketed in Europe for a transplant-related blood cancer, will not hit the U.S. market ...
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ATRA Stock Down After FDA Issues CRL for Rare Blood Cancer Candidate
Shares of Atara Biotherapeutics ATRA plunged 40.5% on Thursday after the FDA issued a complete response letter (CRL) against ...