Sellas Life Sciences is developing an investigational immunotherapy called galinpepimut-S (GPS) for patients with acute myeloid leukemia (AML) who are in a second remission. The company is conducting a Phase 3, event-driven study called REGAL to evaluate whether GPS can prolong survival compared with standard treatment in this population. The accessible portion of the source reports a prediction that the REGAL study will ultimately show a negative outcome — specifically, that GPS will not prolong survival versus the control.
The reporting emphasizes that this is a prediction based on observed trial dynamics rather than on newly released efficacy data. The REGAL study’s design is described as event-driven, meaning its final analysis is triggered when a prespecified number of events (typically deaths for an overall survival endpoint) have occurred.
The article highlights a near one-year delay in the conclusion of the REGAL study as a central reason for skepticism about GPS’s efficacy. In the author’s view, the extended delay in achieving the event threshold for the study’s readout increases the likelihood that the investigational therapy will not demonstrate a survival benefit.
The accessible text frames the delay as an operational signal that has materially altered expectations about the trial’s prospects. However, the source does not detail whether the delay stems from slower-than-expected event accrual, changes in enrollment, protocol amendments, external factors affecting follow-up, or other operational or statistical causes.
From a clinical perspective, the prediction signals caution: if REGAL ultimately fails to show a survival benefit, GPS would not become a new standard of care for AML patients in second remission. For patients and treating clinicians, a negative Phase 3 readout would mean continued reliance on existing therapies and standards.
For investors and stakeholders in Sellas Life Sciences, the article implies potential downside risk for the company’s valuation and for expectations tied to GPS. The author’s characterization of Sellas as a “blowup waiting to happen” reflects an analyst-style assessment that a negative REGAL outcome could be consequential for the company’s business prospects.
The accessible portion of the source omits many details that would be important for independent appraisal of the REGAL study and the prediction of failure. Specifically, the article portion available publicly did not report:
Because these details were not reported in the accessible excerpt, readers cannot verify the operational basis for the prediction from this source alone. Additional information would need to be sought from clinicaltrials.gov entries, company filings and press releases, or direct communications from Sellas and trial investigators.
The commentary and prediction appear in Adam Feuerstein’s Adam’s Biotech Scorecard and were published Sept. 17, 2026, in STAT. The piece in the source is subscriber-gated (STAT+), and the publicly available portion focuses on the author’s forecast that the Phase 3 REGAL trial of GPS will not succeed in prolonging survival. The accessible text frames the prediction around the nearly year-long delay in the event-driven study, but does not present hard trial data or detailed supporting evidence in the excerpt.
Readers seeking to corroborate the article’s conclusions should consult primary sources such as the REGAL trial registry record, Sellas’ corporate disclosures, or independent clinical updates. The source’s publicly available material does not supply the granular trial metrics that would be required to confirm the reported operational concerns or to independently assess the likelihood of a negative efficacy outcome.