FDA issues CRL for Atara's EBVALLO BLA, reversing prior stance on trial adequacy

Atara Biotherapeutics, Inc.

FDA CRL received Jan 9, 2026; confirms GMP issues resolved but claims ALLELE trial inadequate for accelerated approval.
Atara and partner Pierre Fabre plan to request Type A meeting within 45 days to seek path forward.
Cash, cash equivalents and short-term investments as of Dec 31, 2025: approximately $8.5M.
Atara implemented ~90% headcount reduction and reduced ARC lease liability by ~65% in 2025.
Amendment to PFM agreement: approval milestone reduced to $31M, with potential $15M commercial milestone.

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