REGAL Phase 3 reaches 80th event, triggering final analysis
SELLAS announced the pivotal Phase 3 REGAL trial of galinpepimut-S (GPS) in AML reached the pre-specified 80th death event, triggering database lock, unblinding, and final statistical analysis. Topline primary endpoint (overall survival) results are expected this quarter, making the stock a binary event-driven play with sharp near-term volatility. Shares fell ~15% on the news as no survival benefit was disclosed.
SELLAS Press Release (GlobeNewswire)