Overview
- In a new Complete Response Letter, the FDA said it cannot approve the application in its current form, reversing earlier acceptance of ALLELE as adequate for accelerated approval.
- The agency concluded the trial’s design, conduct and analysis confound interpretation of efficacy outcomes.
- FDA reviewers confirmed previously flagged GMP deficiencies were resolved and reported no new safety concerns.
- Atara disputed the reversal and reported a sharp share-price drop of roughly 50% to 55% on the news.
- After transferring the BLA to Pierre Fabre in November 2025, the sponsor plans to seek a Type A meeting, which it expects to be granted within 45 days.