Syros Stock Plunges as Lead Cancer Study Fails to Meet Primary Goal

Core Viewpoint - Syros Pharmaceuticals' shares dropped 86.9% following the failure of its late-stage study of tamibarotene for treating higher-risk myelodysplastic syndrome (HR-MDS), which did not meet the primary endpoint of complete response (CR) rate [1][2]. Group 1: Study Results - The phase III SELECT-MDS-1 study evaluated tamibarotene in combination with azacitidine in newly diagnosed HR-MDS patients, showing a CR rate of 23.8% in the treatment arm compared to 18.8% in the placebo arm, failing to demonstrate statistical significance [2]. - Despite the disappointing CR rates, the combination treatment was reported to be well-tolerated among the enrolled HR-MDS patients, with treatment-related adverse events similar to previous studies [3]. Group 2: Company Impact - Following the study's failure, Syros has decided to halt the HR-MDS study and will conduct a thorough review of the clinical data to determine next steps, marking a significant setback for the company as it now lacks a pipeline candidate [3]. - This incident follows another setback in August 2024, when Syros discontinued enrollment in a mid-stage acute myeloid leukemia (AML) study of tamibarotene due to poor interim results [4]. Group 3: Financial Performance - Year to date, Syros shares have plummeted 95.4%, contrasting sharply with the industry’s decline of 3.8% [3]. - The failure of the SELECT-MDS-1 study to meet its primary endpoint has been classified as an event of default under Syros' secured loan facility with Oxford Finance [3].