Allogene Therapeutics plans to open around 100 ALPHA3 trial sites by year-end after FDA grants key designations for its cell therapy candidate.
Allogene Therapeutics announced the FDA granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations to its lead candidate, cema-cel. The designations aim to accelerate development and review of the therapy, which targets certain cancers.
The company also outlined plans to expand its ALPHA3 trial to approximately 100 clinical sites by the end of 2026. Progress was noted across multiple programs, including ALLO-316 and ALLO-329, during the Q2 2026 earnings call.
CEO Zachary Roberts highlighted the quarter as the start of a new phase for Allogene, emphasizing advancements in its pipeline as key to demonstrating therapeutic potential.