Syndax Reports Third Quarter 2024 Financial Results and Provides Business Update
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Syndax Pharmaceuticals reported its Q3 2024 financial results and provided a business update. Key highlights include new clinical data for revumenib and Niktimvo to be presented at the ASH Annual Meeting, expected topline data for mNPM1 AML from AUGMENT-101 in Q4 2024, and a potential sNDA filing in 1H 2025. Revumenib's NDA for R/R KMT2Ar acute leukemia is under review with a PDUFA date of December 26, 2024. Niktimvo has been approved by the FDA for chronic GVHD treatment, and a $350 million royalty funding agreement is expected to support the company through profitability.

November 05, 2024 | 9:15 pm
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POSITIVE IMPACT
Syndax Pharmaceuticals announced Q3 2024 results with significant updates on its products. Revumenib and Niktimvo will have new data presented at the ASH Annual Meeting. Niktimvo received FDA approval for chronic GVHD, and a $350 million royalty funding agreement is expected to support the company through profitability. Revumenib's NDA is under review with a PDUFA date set for December 26, 2024.
The FDA approval of Niktimvo and the $350 million royalty funding are positive developments for Syndax, likely boosting investor confidence. The upcoming PDUFA date for Revumenib adds potential for further positive impact.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100