Syndax Pharma’s stock prices jump 4% after FDA grants Breakthrough Therapy Designation for revumenib

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Syndax Pharmaceuticals ($NASDAQ:SNDX) is a biopharmaceutical company that focuses on developing targeted small molecule drugs for the treatment of cancer. The company’s stock prices jumped 4% after the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for revumenib to treat arelapsed or refractory acute leukemia. This designation is given to drugs that show considerable promise in treating serious or life-threatening diseases.

Revumenib is currently in clinical trials and Syndax is hopeful that the drug will soon be approved for use in the United States. If approved, revumenib would be the first targeted therapy for acute leukemia and would provide a much needed treatment option for patients with this disease.

Stock Price

On Monday, shares of Syndax Pharmaceuticals Inc. (NASDAQ: SNDX) jumped 4% after the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for its lead candidate, revumenib. This is a significant achievement for the company and its shareholders, as the FDA’s decision could potentially expedite the review and approval process for revumenib. At the time of writing, most news outlets are reporting on the FDA’s decision in a positive light. This is likely to continue to boost Syndax’s stock price in the short-term.

Looking ahead, Syndax is expected to release additional data from its ongoing clinical trials for revumenib in the coming months. This will be crucial in determining whether or not the drug is ultimately approved by the FDA. Live Quote…

About the Company

VI Analysis

The company’s fundamentals reflect its long term potential. However, the company faces several risks that could impact its ability to achieve its goals. In particular, the company has a high debt-to-equity ratio, which could make it difficult to obtain funding for new projects. Additionally, the company has a history of losses, which could impact its ability to generate positive cash flow in the future. Finally, the company faces significant competition, which could limit its ability to grow market share. More…

VI Peers

The biopharmaceutical industry is highly competitive, with companies vying for market share in the development and commercialization of innovative therapies. The company’s main competitors are Fate Therapeutics Inc, Arvinas Inc, and Mirati Therapeutics Inc. All three companies are engaged in the development of cancer therapies, with each company having its own proprietary technology and product pipeline.

– Fate Therapeutics Inc ($NASDAQ:FATE)

Fate Therapeutics is a biopharmaceutical company that develops immunotherapies for cancer and other diseases. The company’s immunotherapies are based on its proprietary platform of induced pluripotent stem cells (iPSCs). Fate Therapeutics’ iPSC platform allows the company to generate fully differentiated, functional immune cells from a patient’s own cells. These immune cells can then be used to treat the patient’s disease. The company’s lead product candidates are FT516, an iPSC-derived natural killer cell therapy, and FT767, an iPSC-derived T cell therapy. Fate Therapeutics is also developing FT819, an iPSC-derived myeloid cell therapy.

– Arvinas Inc ($NASDAQ:ARVN)

Arvinas Inc is a pharmaceutical company that focuses on the development of treatments for cancer and other diseases. The company has a market cap of 2.35B as of 2022 and a Return on Equity of -20.23%. Arvinas was founded in 2013 and is headquartered in New Haven, Connecticut.

– Mirati Therapeutics Inc ($NASDAQ:MRTX)

Mirati Therapeutics Inc is a biopharmaceutical company that focuses on the development of novel small molecule therapeutics to treat cancer. The company’s market cap as of 2022 is 3.7B and its ROE is -33.77%. The company’s main products are targeted cancer therapies, which are designed to selectively target and kill cancer cells while sparing normal cells.

Summary

If you’re looking for a biotech stock with potential upside, Syndax Pharmaceuticals (NASDAQ:SNDX) is worth considering. The stock has been on a tear lately, and there’s good reason to believe that the company’s flagship product, revumenib, could be a success. The FDA recently granted Breakthrough Therapy Designation to revumenib for the treatment of patients with locally advanced or metastatic HER2-positive breast cancer who have received prior trastuzumab and pertuzumab-containing therapy.

This is a major development, as it could speed up the drug’s path to market. The stock is certainly not without risk, but the potential rewards appear to outweigh the risks at this point.