Sellas’ Phase 3 REGAL AML Immunotherapy Study Delayed, Forecast to Miss Survival Endpoint

Sellas Life Sciences Group’s experimental immunotherapy galinpepimut‑S (GPS) is being tested in a Phase 3 REGAL trial for patients with acute myeloid leukemia in a second remission. The study has been delayed by almost a year, prompting questions about the drug’s efficacy.

Adam Feuerstein, a biotech columnist, predicts the trial will not demonstrate a survival advantage over standard therapy and expects a negative outcome when the data are finally read out.

If the delay precedes a failed readout, the result could represent a significant setback for Sellas and may weigh on investor confidence in the company’s pipeline.