Syros Pharmaceuticals Stock Plummets as Phase 3 Trial Falls Short of Primary Goal
Syros Pharmaceuticals (NASDAQ: SYRS) stock plunged 92% in post-market trading on Tuesday following the announcement that its Phase 3 SELECT-MDS-1 trial of tamibarotene, combined with azacitidine for newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) patients with RARA gene overexpression, failed to meet its primary endpoint. Tamibarotene is an oral, selective retinoic acid receptor alpha (RARα) agonist.
The trial’s complete response (CR) rate in the tamibarotene/azacitidine arm was 23.8%, compared to 18.8% in the placebo/azacitidine control arm, failing to achieve statistical significance. Syros stated that tamibarotene was generally well-tolerated, showing a safety profile consistent with earlier studies.
Conley Chee, CEO of Syros commented, “We are deeply disappointed by this outcome, particularly for the HR-MDS patients who are seeking a new treatment option for this challenging disease. We plan to stop the study, review the clinical data more thoroughly, and evaluate the next steps. We want to express our sincere appreciation for the patients, caregivers and healthcare professionals who took part in the SELECT-MDS-1 trial and to all the employees of Syros for their exceptional work on the tamibarotene program.”
The trial’s failure triggered a default event under Syros’ secured loan facility with Oxford Finance LLC. Syros will discontinue the trial, thoroughly review the data, and evaluate next steps.
