Atara receives FDA Complete Response Letter for EBVALLO BLA due to third-party manufacturing issues

Atara Biotherapeutics, Inc.

FDA CRL solely related to third-party manufacturer inspection findings; no clinical efficacy/safety issues, no new trials requested.
Atara expects resubmission within 6 months after GMP compliance resolved; potential approval within 6 months of resubmission.
Preliminary cash and investments ~$43M as of Dec 31, 2024; non-binding term sheet with Redmile for up to $15M equity line.
Atara exploring strategic alternatives; may suspend CAR-T activities if no funding by Q1 2025; committed to preserving EBVALLO value.
Atara remains eligible for $60M milestone from Pierre Fabre upon FDA approval and double-digit royalties.

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