Syros (SYRS) Stock Rises More Than 35% in 3 Months: Here's Why

Core Insights - The FDA granted Fast Track designation to tamibarotene for treating acute myeloid leukemia (AML) in April 2024 [1] - Initial data from the SELECT-AML-1 study indicated a 100% complete response (CR) rate for patients treated with tamibarotene, Venclexta, and azacitidine, compared to a 70% CR rate for those receiving Venclexta and azacitidine alone [2][5] - Syros Pharmaceuticals is developing tamibarotene as a frontline treatment for AML and higher-risk myelodysplastic syndrome (HR-MDS) [3] Company Performance - Syros Pharmaceuticals' stock has increased by 38.1% over the past three months, outperforming the industry average increase of 10.8% [4] - The company is preparing a new drug application for tamibarotene in HR-MDS, aiming to establish it as the new frontline standard of care for patients with RARA overexpression [7] - Syros currently holds a Zacks Rank of 3 (Hold) [15] Clinical Trials and Data - The SELECT-AML-1 study is evaluating tamibarotene in combination with Venclexta and azacitidine in newly diagnosed AML patients with RARA gene overexpression, with pivotal data expected in the third quarter of 2024 [5][6] - The phase III SELECT-MDS-1 study is assessing tamibarotene with azacitidine in newly diagnosed HR-MDS patients, with key complete response data anticipated by mid-fourth quarter of 2024 [13][14] Regulatory Designations - The FDA has previously granted Fast Track designation to tamibarotene in combination with azacitidine for treating adults with HR-MDS and RARA overexpression [11] - The combination of tamibarotene, azacitidine, and Venclexta has received Fast Track designation for treating newly diagnosed AML in adults over 75 or those with comorbidities that prevent intensive chemotherapy [10]