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 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 virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases,
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),
Atara extends losses after FDA clinical hold
Atara Biotherapeutics (ATRA) stock slips as company faces an FDA clinical hold after rejection of lead candidate Ebvallo. Read more here.
Atara Biotherapeutics Faces Strategic Uncertainty Amid FDA Hold and CRL Issues
H.C. Wainwright analyst Robert Burns has reiterated their neutral stance on ATRA stock, giving a Hold rating yesterday.Invest with Confidence:
Atara Biotherapeutics: Another Dip Buying Opportunity Following CRL For CMC Issues
Atara Biotherapeutics has just announced a CRL by FDA for EBVALLO. Click here to read more about ATRA stock and why it is ...
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 ...
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 ...
BioSpace1d
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 ...
Atara Biotherapeutics Shares Plunge 38% Following FDA Response to EBVALLO Application
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FiercePharma7d
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 ...
precisionmedicineonline2d
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.
Atara Biotherapeutics, Inc. Being Investigated on Behalf of Atara Biotherapeutics, Inc. Investors. Contact Levi & Korsinsky For Details
NEW YORK, NY / ACCESS Newswire / January 22, 2025 / Levi & Korsinsky notifies investors that it has commenced an investigation of Atara ...