We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
Syndax Pharmaceuticals Inc | NASDAQ:SNDX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.11 | -0.50% | 21.86 | 21.44 | 22.28 | 22.33 | 21.50 | 22.11 | 1,276,876 | 21:11:22 |
By Colin Kellaher
Syndax Pharmaceuticals Inc. on Monday said the U.S. Food and Drug Administration granted breakthrough-therapy designation to its revumenib drug candidate for the treatment of certain leukemia patients.
The Waltham, Mass., clinical-stage biopharmaceutical company said the designation covers revumenib for adults and children with relapsed or refractory acute leukemia harboring a KMT2A rearrangement, or KMT2Ar.
The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.
Syndax said revumenib has the potential to be the first FDA-approved drug to address KMT2Ar leukemia, which is believed to occur in up to 10% of all acute leukemias, including in roughly 80% of infant acute leukemias.
Syndax said it is on track to file for FDA approval of revumenib by the end of next year, with the potential for an expedited approval with a broad indication.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 05, 2022 07:57 ET (12:57 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
1 Year Syndax Pharmaceuticals Chart |
1 Month Syndax Pharmaceuticals Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions