SELLAS Life Sciences Group (SLS) surges 14.94% on pivotal Phase 3 REGAL trial update

SELLAS Life Sciences Group (SLS) surged 14.9425% in pre-market trading on January 6, 2026, following a pivotal update on its Phase 3 REGAL trial for galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML). The trial reached 72 of the 80 total survival events required for final analysis by December 26, 2025, with the Independent Data Monitoring Committee recommending no modifications to the study. This milestone has intensified investor focus on the upcoming overall survival readout, a critical catalyst for the company’s pipeline narrative.

The progress in the REGAL trial, coupled with SELLAS’s decision to maintain blinding of efficacy data and host an AML-focused R&D Day, underscores the binary nature of the upcoming results.

While the final readout could reshape perceptions of GPS’s potential and funding options, risks such as ongoing cash burn and the possibility of further equity raises remain central concerns. The stock’s recent volatility reflects heightened expectations around the trial’s outcome and its implications for the company’s long-term viability.

Investor sentiment remains divided, with fair value estimates spanning a wide range, highlighting the speculative nature of the investment. As SELLAS navigates this inflection point, stakeholders will closely monitor how the data aligns with its ambitious pipeline goals and whether it can justify its valuation amid ongoing financial challenges.

As anticipation for the overall survival data continues to build, market watchers are analyzing SELLAS’s financial sustainability and its ability to maintain investor confidence through transparent communication. The stock’s sharp pre-market movement is a clear indicator of the emotional and speculative trading taking place around the Phase 3 results. Investors are also closely watching how the company will manage its capital structure and whether it will seek additional financing before the final data becomes public.