Clinical TrialAug 12, 2026, 04:06 PM
Allogene Cema-Cel Gets RMAT/Fast Track; ALPHA3 Interim Positive
AI Summary
Allogene Therapeutics announced that its lead candidate, cema-cel, received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA following a positive interim futility analysis for the pivotal Phase 2 ALPHA3 trial in LBCL. The trial showed 58.3% MRD negativity in the cema-cel arm compared to 16.7% in the observation arm, with accelerated site activation and enrollment expected to complete by year-end 2027. The company also reported a Q2 2026 net loss of $42.7 million and a strong cash position of $423.6 million, extending its cash runway into 2029.
Key Highlights
- Cema-cel granted RMAT and Fast Track designations by FDA.
- ALPHA3 interim futility analysis showed 58.3% MRD negativity in cema-cel arm vs 16.7% in observation arm.
- ALPHA3 site activation accelerated, now expecting ~100 sites by year-end 2026.
- ALPHA3 enrollment expected to complete by year-end 2027; next update mid-2027.
- ALLO-329 Phase 1 RESOLUTION trial enrollment continues briskly; data update Q4 2026.
- Q2 2026 net loss was $42.7 million, or $0.13 per share.
- Ended Q2 2026 with $423.6 million in cash, cash equivalents, and investments.
- Cash runway projected into 2029.
Price Impact
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