CAMBRIDGE, Mass. - Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of treatments for hematologic cancers, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its drug candidate tamibarotene for the treatment of acute myeloid leukemia (AML).
This regulatory milestone is specifically for the use of tamibarotene in combination with azacitidine and venetoclax in newly diagnosed AML patients who are either over 75 years old or have comorbidities that prevent them from undergoing intensive induction chemotherapy.
The Fast Track Designation is intended to accelerate the development and review of drugs that treat serious conditions and fill an unmet medical need. It allows for more frequent communication with the FDA and may lead to priority review and accelerated approval based on clinical data.
David A. Roth, M.D., Chief Medical Officer of Syros Pharmaceuticals, indicated that the designation underscores the urgent need for effective treatments for AML patients, particularly those who are unfit for intensive treatment regimens. He expressed optimism about the potential of tamibarotene, especially following promising interim results from the SELECT-AML-1 clinical trial.
In this study, patients treated with tamibarotene in combination with venetoclax and azacitidine achieved a 100% complete response rate, compared with a 70% rate in those receiving only venetoclax and azacitidine.
Tamibarotene, an oral selective retinoic acid receptor alpha agonist, is being tested in the ongoing SELECT-AML-1 Phase 2 trial. The initial data from December 2023 showed that all response-evaluable patients treated with the triplet regimen achieved a complete response by the end of the first treatment cycle, without added toxicity or new safety concerns.
Additional data from the SELECT-AML-1 trial is expected to be released later this year. Syros is also conducting a SELECT-MDS-1 Phase 3 trial to evaluate tamibarotene in combination with azacitidine in patients with higher-risk myelodysplastic syndrome (MDS) who exhibit RARA gene overexpression. The company completed enrollment for the primary efficacy analysis in the first quarter of 2024 and anticipates reporting pivotal complete response data by mid-fourth quarter of 2024.
This news is based on a press release statement from Syros Pharmaceuticals.
InvestingPro Insights
As Syros Pharmaceuticals (NASDAQ:SYRS) garners attention with the FDA's Fast Track Designation for its AML treatment, investors are closely monitoring the company's financial health and stock performance. According to InvestingPro, Syros holds more cash than debt on its balance sheet, which could provide some financial flexibility as the company advances its clinical trials. However, the company is quickly burning through cash, which is a point of concern for long-term sustainability.
From a market perspective, Syros' stock price has shown significant volatility, a characteristic that might appeal to certain investors but could also signal caution for those seeking stability. The company's market capitalization currently stands at 119.04 million USD, reflecting the market's valuation of the company's potential. Despite some challenges, such as weak gross profit margins and a notable sales decline anticipated in the current year, Syros' liquid assets exceed its short-term obligations, providing a cushion for near-term operational needs.
For a more comprehensive analysis, interested parties can explore additional InvestingPro Tips on Syros Pharmaceuticals, which include insights into the stock's valuation, profitability expectations, and price movements. With the use of coupon code PRONEWS24, readers can get an additional 10% off a yearly or biyearly Pro and Pro+ subscription to access these insights. There are 15 more InvestingPro Tips available that delve deeper into the financial and stock performance metrics of Syros, which could prove invaluable for making informed investment decisions.
Investors can also find the company's key financial metrics, such as a Price / Book ratio of 7.14 and a notable revenue growth of 151.19% in the most recent quarter, which could be indicative of the company's growth trajectory. However, the negative gross profit margin and operating income margin highlight the financial challenges Syros faces. The company's next earnings date is set for May 2, 2024, which will be a critical time for investors to assess the company's progress and future prospects.
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