Syros Pharmaceuticals Inc (SYRS) News & EventsSYRSNews & EventsSyros Pharmaceuticals Inc

Syros Pharmaceuticals sells Tamibarotene assets to Rege Nephro

Rege Nephro has announced that it has successfully acquired Tamibarotene-related clinical and non-clinical assets from Syros Pharmaceuticals, through a mutual agreement. The acquisition was completed on February 26. This acquisition, encompassing their clinical and non-clinical data including human safety study for new drug application, contracts with a contract manufacturing organization, and Tamibarotene active pharmaceutical ingredient and drug products, is expected to enhance Rege Nephro's capabilities and streamline operations for its clinical trial operations in the United States.

Syros Pharmaceuticals voluntarily delists from Nasdaq, deregisters common stock

Syros Pharmaceuticals announced that its Board of Directors has approved and the company intends to proceed with the voluntary delisting of its common stock from the Nasdaq Stock Market and the deregistration of its common stock in order to terminate and suspend the company's reporting obligations under the Securities and Exchange Act of 1934, as amended. The company notified Nasdaq of its intention to voluntarily delist its shares of common stock from the Nasdaq Global Select Market. The company intends to file a Form 25 with the SEC to effect the delisting and deregistration of its common stock on or about March 10, and the delisting is expected to become effective on or about March 20.

Syros Pharmaceuticals says SELECT-MDS-1 trial did not meet primary endpoint

Syros Pharmaceuticals announced that the SELECT-MDS-1 Phase 3 trial evaluating tamibarotene in combination with azacitidine in newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) patients with RARA gene overexpression did not meet its primary endpoint of complete response (CR) rate. Tamibarotene is Syros' proprietary oral, selective, retinoic acid receptor alpha (RARalpha) agonist. In the first 190 enrolled patients, the CR rate by intent-to-treat (ITT) in the tamibarotene/azacitidine treatment arm was 23.8% (n=126; 95% CI: 16.7%-32.2%) compared to a CR rate of 18.8% (n=64; 95% CI: 10.1%-30.5%) in the placebo/azacitidine control arm and was not statistically significant (p-value = 0.2084). In the safety analysis of all enrolled patients (n=245), tamibarotene in combination with azacitidine (n=160) appeared to be generally well-tolerated, with an adverse event profile that was similar to that seen in earlier Syros-sponsored studies. Syros also reported that, as previously disclosed in its filings with the SEC, the failure of the SELECT-MDS-1 trial to achieve its primary endpoint constitutes an event of default under its secured loan facility with Oxford Finance LLC. "We are deeply disappointed by this outcome, particularly for the HR-MDS patients who are seeking a new treatment option for this challenging disease," said Conley Chee, Chief Executive Officer of Syros. "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."