FDA Places Clinical Hold On Atara Biotherapeutics' Two Cell Therapy Programs

Core Insights - The U.S. FDA has placed a clinical hold on Atara Biotherapeutics' ATRA active IND applications, affecting the EBVALLO program and ATA3219 therapy [1][3] - Current subjects in clinical studies may continue treatment, but new participant enrollment is paused [2] - The clinical hold is linked to GMP compliance issues at a third-party manufacturing facility, impacting both EBVALLO and ATA3219 [3][4] Group 1: Clinical Hold Details - The hold on EBVALLO is due to GMP compliance issues identified during a pre-license inspection [3] - ATA3219 is manufactured at a compliant facility, but the compliance issues affect its starting materials [3][4] - The issues are specific to one third-party facility and do not impact Atara's other manufacturer, FUJIFILM Diosynth Biotechnologies [4] Group 2: Financial and Strategic Implications - Atara is eligible for a $60 million milestone payment from Pierre Fabre upon FDA approval of EBVALLO BLA [5] - The company plans to suspend CAR-T activities and reduce expenses if funding is not secured by Q1 2025 [6] - Atara has a non-binding term sheet with Redmile Group for up to $15 million in funding [7] Group 3: Market Reaction - Following the news, ATRA stock decreased by 4.09%, trading at $6.302 [7]