FDA accepts Adaptimmune’s BLA for afami-cel for synovial sarcoma

1 February 2024

Adaptimmune Therapeutics (Nasdaq: ADAP) saw its shares leap almost 10% by close of trading Wednesday and a further 5.2% to $1.01 in after-hours trading as it announced a regulator development for its cell therapy.

The company revealed that the US Food and Drug Administration (FDA) has accepted for priority review its Biologics License Application (BLA) for afami-cel, an investigational engineered T-cell therapy for advanced synovial sarcoma. Adaptimmune said it anticipates an approval for afami-cel in the third quarter of of 2024.

The application for Afami-cel has a Prescription Drug User Fee Act (PDUFA) target action date of August 4, 2024

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