---
title: "Sellas Phase 3 REGAL trial for galinpepimut-S faces delays and likely negative outcome in AML"
id: "stat-news-1-stat-a-sellas-immunotherapy-study-long-delayed-will-end-in-failure"
canonical_url: "https://medichelpline.com/clinical-feed/stat-news-1-stat-a-sellas-immunotherapy-study-long-delayed-will-end-in-failure"
content_type: "clinical_feed_article"
specialty: "Oncology"
source_name: "STAT News"
source_url: "https://www.statnews.com/2026/09/17/sellas-immunotherapy-study-acute-myeloid-leukemia/?utm_campaign=rss"
published_at: "2026-09-17T10:30:00.000Z"
evidence_level: "Verified Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Sellas Phase 3 REGAL trial for galinpepimut-S faces delays and likely negative outcome in AML
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/stat-news-1-stat-a-sellas-immunotherapy-study-long-delayed-will-end-in-failure
- **Specialty:** [Oncology](https://medichelpline.com/clinical-feed/oncology.md)
- **Primary Source:** STAT News
- **Source URL:** [Original Journal Publication](https://www.statnews.com/2026/09/17/sellas-immunotherapy-study-acute-myeloid-leukemia/?utm_campaign=rss)
- **Published At:** 2026-09-17T10:30:00.000Z
- **Evidence Rating:** Verified Feed
## Executive GIST (TL;DR)
- Sellas Life Sciences’ investigational immunotherapy **galinpepimut-S (GPS)** is being evaluated in the Phase 3 REGAL study for patients with **acute myeloid leukemia (AML)** in second remission. The article’s author predicts the trial will fail to show a survival benefit versus standard treatment. - The REGAL study is event-driven and has experienced a delay of nearly one year in reaching its conclusion. That delay is cited as a major reason for skepticism about the drug’s efficacy. - The prediction of a negative outcome is based on the timing and magnitude of the study’s delay rather than on newly released efficacy data; the article does not provide trial results or internal data supporting the forecast. - The coverage is subscriber-restricted (STAT+); portions of the original reporting are behind a paywall. The publicly available text emphasizes concerns about Sellas’ prospects but does not include detailed trial metrics, enrollment figures, or independent data analyses. - The story is authored by Adam Feuerstein and was published Sept. 17, 2026, in STAT’s Adam’s Biotech Scorecard. It frames Sellas as vulnerable to a clinical and commercial setback if REGAL reads out negatively. - Key specifics such as the exact reason(s) for the nearly one-year delay, the current event threshold driving the trial’s readout, interim analyses, statistical assumptions, survival hazard ratios, and enrollment status were not reported in the accessible portion of the source. - The article situates the REGAL study concern within broader biotech reporting on drug development risk, but it does not present alternative expert opinions, regulatory communications, or Sellas’ formal responses in the accessible excerpt. - Clinicians and investors should note that the publicly available account is an analyst-style prediction based on observed operational signals (trial delay) rather than disclosed trial outcomes; additional verification from trial registries, company statements, or independent data would be required to confirm the study’s status and results.
## Clinical Analysis & Structured Key Points
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Test your knowledge with our new weekday mini crossword [ Start solving ](https://www.statnews.com/stat-mini-crossword/) [STAT Plus](https://www.statnews.com/stat-plus/)Opinion[Adam’s Biotech Scorecard](https://www.statnews.com/category/adams-biotech-scorecard/) # A Sellas immunotherapy study, long delayed, will end in failure ## The prediction is based on delays that have raised significant doubts about the drug’s efficacy * [Manage alerts for this article](https://www.statnews.com/my-account/edit/#emails) * [Save this story for later](https://www.statnews.com/my-account/saved/) * [Share this article](https://www.statnews.com/2026/09/17/sellas-immunotherapy-study-acute-myeloid-leukemia/?utm_campaign=rss) ![Adam's take main illustration](https://www.statnews.com/wp-content/uploads/2022/06/AdamsTake_Illustration_MollyFerguson_061322-645x645.jpg) Molly Ferguson/STAT ![](https://www.statnews.com/wp-content/uploads/2021/02/adam-f-avatar-small2-80x80.png) By [Adam Feuerstein](https://www.statnews.com/staff/adam-feuerstein/) Sept. 17, 2026 Senior Writer, Biotech ![](https://www.statnews.com/wp-content/uploads/2021/02/adam-f-avatar-small2-80x80.png) [Adam Feuerstein](https://www.statnews.com/staff/adam-feuerstein/) 1. [](https://x.com/adamfeuerstein "X") adam.feuerstein@statnews.com Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast [The Readout Loud](https://www.statnews.com/category/readout-loud/) and author of the newsletter [Adam’s Biotech Scorecard.](https://www.statnews.com/signup/scorecard/) You can reach Adam on Signal at stataf.54. _This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up[here](https://www.statnews.com/signup/scorecard/) to get it delivered to their inbox._ Sellas Life Sciences Group is a blowup waiting to happen. My prediction: Sellas’ experimental immunotherapy will fail to prolong survival compared to standard treatment for patients with acute myeloid leukemia in a second remission. Advertisement I’m confident in my prediction the company’s Phase 3 REGAL study will have a negative outcome; I just don’t know when it will happen. The conclusion of the event-driven study has already been delayed by nearly a year — raising significant doubts about the efficacy of the Sellas treatment, called galinpepimut-S, or GPS. [![STAT+](https://www.statnews.com/wp-content/themes/stat/images/stat-plus-logo.svg)](https://www.statnews.com/stat-plus/) To read the rest of this story subscribe to STAT+. 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