WALTHAM, Mass. - Syndax Pharmaceuticals (NASDAQ:SNDX), a clinical-stage biopharmaceutical company, announced today that its New Drug Application (NDA) for revumenib has been granted Priority Review by the U.S. Food and Drug Administration (FDA). Revumenib is aimed at treating adult and pediatric patients with relapsed or refractory KMT2A-rearranged acute leukemia.
The FDA's decision to expedite the review process comes with a Prescription Drug User Fee Act (PDUFA) target action date set for September 26, 2024. The application is being assessed under the FDA's Real-Time Oncology Review (RTOR) program, which is designed to streamline the review process for promising oncology drugs.
According to Syndax, the NDA submission for revumenib was supported by positive results from the AUGMENT-101 trial, which met its primary endpoint. The trial reported a complete remission rate of 23% among patients with KMT2A-rearranged acute leukemia. Additionally, 70% of patients who achieved complete remission and were tested for minimal residual disease were found to be MRD negative.
Revumenib is a small molecule inhibitor targeting the menin-KMT2A interaction, which is implicated in certain acute leukemias. The drug has also received Orphan Drug Designation, Fast Track designation, and Breakthrough Therapy Designation from the FDA for the treatment of acute leukemia with KMT2A rearrangement.
Syndax's CEO, Michael A. Metzger, expressed that the Priority Review marks a significant milestone for the company as it prepares to launch its product commercially. The company is focused on commercial preparations to ensure a smooth transition to a commercial-stage oncology company.
The RTOR program allows for early and iterative communication between the drug sponsor and the FDA, potentially leading to earlier drug approvals. This program is part of the FDA's efforts to get effective treatments to patients as soon as possible.
The article is based on a press release statement by Syndax Pharmaceuticals. The company is developing a pipeline of cancer therapies, including revumenib and axatilimab, a monoclonal antibody. For more information, Syndax can be followed on X (formerly Twitter) and LinkedIn.
InvestingPro Insights
Syndax Pharmaceuticals, while advancing its clinical pipeline with a focus on revumenib, shows a complex financial landscape. According to InvestingPro data, the company holds a market capitalization of $1.83 billion.
Despite its ambitious clinical developments, the company's P/E ratio stands at -7.22, reflecting its current lack of profitability. This is further highlighted by an adjusted P/E ratio for the last twelve months as of Q4 2023 at -8.72, indicating an increased valuation against earnings compared to the standard P/E ratio.
InvestingPro Tips for Syndax suggest caution, with four analysts having revised their earnings downwards for the upcoming period, which could be indicative of challenges ahead. Moreover, the company does not pay dividends to shareholders, which may impact investor returns, especially for those seeking income from their investments. Still, it is worth noting that Syndax has experienced a large price uptick over the last six months, with a 42.39% return, showcasing significant market optimism.
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