Sellas Nears Pivotal Phase 3 Readout for Galinpepimut-S in AML as Regal Trial Approaches Final Analysis
核心洞察
Sellas Life Sciences' Phase 3 Regal trial of Galinpepimut-S (GPS) in acute myeloid leukemia (搜索) has recorded 78 of the 80 events required to trigger final analysis, placing the company near a pivotal readout.
The trial will be deemed successful if GPS achieves median overall survival of 12.6 months versus eight months for the control arm, potentially supporting a biologics license application to the FDA.
CEO Angelos Stergiou called the delay in reaching the final event "a profoundly positive signal," suggesting patients may be living longer than projected.
Sellas Life Sciences is approaching one of the most consequential clinical readouts in its history, as its Phase 3 Regal trial of Galinpepimut-S (GPS) in acute myeloid leukemia (搜索) (AML) has recorded 78 of the 80 events required to trigger the final analysis. The company plans to announce when the 80th event occurs before proceeding with the customary database lock, blinded review, statistical analysis, and unblinding.
CEO Angelos Stergiou recently characterized the delay in reaching the final event as "a profoundly positive signal," indicating that patients may be living longer than originally projected. The study will be considered successful if GPS produces a median overall survival of 12.6 months, compared with eight months for the control arm. A positive outcome could support a biologics license application to the Food and Drug Administration.
Sellas has entered a clinical quiet period as it prepares for the final analysis, underscoring the significance of the upcoming data disclosure.
Beyond the Regal trial, Sellas is separately advancing SLS009, a distinct investigational agent. The company has enrolled 28 of a planned 80 patients in a Phase 2 trial involving newly diagnosed AML, with initial results expected in the fourth quarter of 2026.
The clinical milestones have drawn notable institutional attention. Virginia Retirement System (搜索), which manages $124 billion in net assets and serves more than 860,000 active and retired members, reported holding 17,400 shares of SLS as of June 30, according to Fiscal AI data. The pension fund's SLS position was valued at $256,824 at the end of the second quarter.
Other institutions have also increased their exposure to Sellas. California State Teachers' Retirement System raised its stake more than 20-fold to 202,374 shares, while Susquehanna added 1.65 million shares to reach 2.05 million. Jones Financial increased its position to 2.3 million shares, and Wellington Management lifted its holding by 73% to 597,309 shares. Sellas had 176 reported institutional holders.
On Stocktwits, retail sentiment for SLS was described as "extremely bullish" amid "high" message volume, while SLS stock has surged 510% over the past year.