Syndax Announces FDA Priority Review of NDA for Revumenib for the Treatment of Relapsed/Refractory KMT2Ar Acute Leukemia [Yahoo! Finance]
Syndax Pharmaceuticals, Inc. (SNDX)
Last syndax pharmaceuticals, inc. earnings: 3/3 04:05 pm
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Source: Yahoo! Finance
WALTHAM, Mass. March 26, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its New Drug Application (NDA) for revumenib, the Company's first-in-class menin inhibitor, for the treatment of adult and pediatric relapsed or refractory (R/R) KMT2A-rearranged (KMT2Ar) acute leukemia. The NDA filing is being reviewed under the FDA's Real-Time Oncology Review Program (RTOR) and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 26, 2024 . RTOR allows for a more efficient review and close engagement between the sponsor and the FDA throughout the submission process, which historically has led to earlier approvals. "The receipt of Priority Review for the revumenib NDA filing is a significant milestone as we transition to a leading commercial-stage onco
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SNDX
News
- Syndax Pharmaceuticals, Inc. (NASDAQ: SNDX) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $41.00 price target on the stock.MarketBeat
- Syndax Announces Participation at the Stifel 2024 Virtual Targeted Oncology Forum [Yahoo! Finance]Yahoo! Finance
- Syndax Announces Participation at the Stifel 2024 Virtual Targeted Oncology ForumPR Newswire
- Syndax Presents Positive Pediatric Data from Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia at ASPHO Plenary Session [Yahoo! Finance]Yahoo! Finance
- Syndax Presents Positive Pediatric Data from Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia at ASPHO Plenary SessionPR Newswire
SNDX
Earnings
- 2/27/24 - Miss
SNDX
Sec Filings
- 4/2/24 - Form ARS
- 4/2/24 - Form DEFA14A
- 4/2/24 - Form DEF
- SNDX's page on the SEC website