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,
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),
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 just yet, forcing the company to “significantly reduce expenses.”
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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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 ...
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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 Biotherapeutics Provides Regulatory and Business Update on EBVALLOTM (tabelecleucel)
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr ...
Atara Biotherapeutics price target lowered to $5 from $10 at Stifel
Stifel lowered the firm’s price target on Atara Biotherapeutics (ATRA) to $5 from $10 and keeps a Hold rating on the shares after the FDA has ...
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Atara Biotherapeutics Receives FDA Complete Response Letter for Ebvallo
The FDA didn't approve the therapy in EBV-positive post-transplant lymphoproliferative disease due to findings at a third-party manufacturing facility.