WALTHAM, Mass. - Syndax Pharmaceuticals Inc. (NASDAQ: NASDAQ:SNDX), a biopharmaceutical company focused on developing cancer therapies, disclosed that the U.S. Food and Drug Administration (FDA) has extended the review period for its New Drug Application (NDA) for revumenib. This drug is intended for the treatment of adults and pediatric patients with relapsed or refractory KMT2Ar acute leukemia.
The FDA has set a new Prescription Drug User Fee Act (PDUFA) action date of December 26, 2024, providing additional time to review supplemental information submitted by Syndax. The company provided this information in response to FDA requests, which led to a standard three-month extension from the original PDUFA date of September 26, 2024.
Syndax's CEO, Michael A. Metzger, expressed confidence in the data supporting revumenib's approval, citing the AUGMENT-101 trial results and additional information provided to the FDA. He emphasized the drug's potential benefit for patients with KMT2A-rearranged acute leukemia, a condition with a significant unmet medical need.
Revumenib has received Priority Review and is undergoing the FDA's Real-Time Oncology Review (RTOR) program. The drug has also been granted Breakthrough Therapy, Fast Track, and Orphan Drug designations by the FDA for its use in acute leukemias.
The RTOR program aims to expedite the review process for oncology drugs, ensuring early access to safe and effective treatments, while enhancing review quality and facilitating communication between the FDA and the drug sponsor.
Syndax Pharmaceuticals has been the focus of several analyst evaluations and strategic developments. The company received a Buy rating from Jefferies with a price target of $37.00, while Stifel raised its price target to $42.00, maintaining a Buy rating.
These ratings come as Syndax anticipates two significant PDUFA dates for its therapies revumenib and axatilimab. Revumenib, a treatment for acute myeloid leukemia, has shown promising results in trials and is anticipated to be first-to-market for a substantial portion of AML cases. Axatilimab, aimed at treating chronic graft versus host disease, is also nearing its PDUFA date.
Syndax's transition to a commercial stage is underscored by its strong cash position of $522 million, expected to last through 2026. The company has also welcomed new board member Aleksandra Rizo, M.D., Ph.D., an expert in hematology drugs.
InvestingPro Insights
Amidst the anticipation for Syndax Pharmaceuticals' revumenib FDA approval timeline, investors and stakeholders are closely watching the company's financial health and market performance. Syndax, with a market capitalization of approximately $2.08 billion, is navigating the biopharmaceutical sector with significant milestones in sight.
According to InvestingPro data, Syndax has been trading near its 52-week high with a price percentage of 96.65%. This is a bullish indicator for many investors, reflecting a strong market confidence in the company's prospects. The company's recent price momentum is also notable, with a 19.29% return over the last month, underlining its robust short-term performance. This could correlate with investor optimism around the potential market impact of revumenib.
Two key InvestingPro Tips for Syndax Pharmaceuticals highlight the company's financial position and analyst sentiment. Firstly, Syndax holds more cash than debt on its balance sheet, which is a reassuring sign of financial stability and may provide the company with the flexibility to navigate the regulatory process without immediate financial pressure. Secondly, 8 analysts have revised their earnings upwards for the upcoming period, suggesting a positive outlook on the company's revenue potential, possibly buoyed by the market opportunities for revumenib.
Despite these positive indicators, it is also important to note that Syndax is not currently profitable, with a negative P/E ratio of -7.59, and analysts do not anticipate profitability this year. This underscores the high-risk, high-reward nature of investing in biopharmaceutical companies, where the success of clinical trials and regulatory approvals can significantly impact financial outcomes.
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