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Atara In Disarray As Shares Sink On Ebvallo CRL

 
• By Kevin Grogan

The Pierre Fabre-partnered allogeneic T-cell immunotherapy is already available in Europe but hopes of a US approval have been hit by a complete response letter citing problems at a third-party manufacturing facility.

Delay
• Source: Shutterstock

Atara Biotherapeutics' hopes of getting Ebvallo approved soon in the US have been dashed after the Food and Drug Administration rejected the off-the-shelf cell therapy due to manufacturing issues, sending the US biotech’s shares through the floor and threatening its survival.

Ebvallo (tabelecleucel), which was approved by the European Medicines Agency in December 2022 for the treatment of relapsed or refractory Epstein‑Barr virus-positive post‑transplant lymphoproliferative disease, has been hit with a complete response letter (CRL) from the agency which is “solely related to inspection findings at a third-party manufacturing facility

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