REGAL Trial Hits 80th Event, Unlocking Final Phase 3 AML Analysis
SLS has more than doubled off its 52-week low of $1.39.
Summary
SELLAS hit the pre-specified 80th death event in the pivotal Phase 3 REGAL trial of galinpepimut-S in second-remission AML, which triggers database lock, unblinding and the final overall-survival analysis. Topline primary endpoint results are now due this quarter — the binary readout the entire thesis rests on. This follows the October 1 report that the company was approaching the 80-event trigger, and the August 8-K/10-Q showing $138.3 million in cash, so funding is not the near-term constraint. Positive data would support GPS as a first-in-class WT1 immunotherapy in a setting with few options; a miss leaves little behind it. Watch for the topline release before year-end.
At the time of this announcement, SLS was trading at $12.75 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $2.5B. The 52-week trading range was $1.39 to $15.88. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.