Syndax (SNDX) Gets FDA Priority Tag for Leukemia Drug NDA [Yahoo! Finance]
Syndax Pharmaceuticals, Inc. (SNDX)
Last syndax pharmaceuticals, inc. earnings: 3/3 04:05 pm
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Source: Yahoo! Finance
The NDA seeks approval of revumenib, a first-in-class menin inhibitor, for the treatment of patients with relapsed/refractory acute leukemia harboring a KMT2A rearrangement. The FDA's targeted action date is Sep 26, 2024. The NDA filing is being reviewed under the FDA's Real-Time Oncology Review Program (RTOR).The RTOR program facilitates efficient engagement between sponsors and the FDA, historically leading to expedited approvals. The NDA was based on data from the AUGMENT-101 study.At the protocol-defined interim analysis, the study met its primary endpoint with a notable complete remission (CR) or a CR with partial hematological recovery (CRh) rate of 23% among the 57 efficacy evaluable patients in the pooled KMT2Ar acute leukemia population. Moreover, the data revealed a significant correlation between treatment response and minimal residual disease (MRD) status, with 70% of patients achieving CR/CRh also demonstrating MRD negativity. Furthermore, the study demonstrated an
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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