Syndax stock rises after FDA grants Priority Review for cancer drug expansion

Published 24/06/2025, 21:30
© Reuters.

Investing.com -- Syndax Pharmaceuticals Inc (NASDAQ:SNDX) stock gained 2.5% after the FDA granted Priority Review for its supplemental New Drug Application (sNDA) for Revuforj, potentially expanding the drug’s use to treat relapsed or refractory mutant NPM1 acute myeloid leukemia.

The FDA assigned a PDUFA target action date of October 25, 2025, for the application, which is being reviewed under the FDA’s Real-Time Oncology Review program. This program allows for more efficient review and closer engagement between Syndax and regulators throughout the submission process.

Revuforj, an oral menin inhibitor, received initial FDA approval in 2024 for treating relapsed or refractory acute leukemia with a KMT2A translocation in adult and pediatric patients one year and older. If approved, this expansion would include patients with NPM1 mutations, which represent the most common genetic alteration in acute myeloid leukemia.

"We are pleased that the FDA has granted Priority Review to our sNDA in R/R mNPM1 AML, a filing which builds on the initial approval of Revuforj for R/R acute leukemia with a KMT2A translocation in 2024," said Michael A. Metzger, Chief Executive Officer of Syndax.

The sNDA submission is supported by positive pivotal data from the AUGMENT-101 trial. Results from this study were published in the journal Blood in May 2025 and presented at the European Hematology Association Annual Congress Meeting in June 2025.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers
© 2007-2025 - Fusion Media Limited. All Rights Reserved.