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Sep 30, 2023
Syndax Q3 2023 Earnings Report
Syndax reported third quarter 2023 financial results and provided a clinical and business update.
Key Takeaways
Syndax Pharmaceuticals reported its financial results for the quarter ended September 30, 2023. The company continues to advance its pipeline, with NDA submission initiated for revumenib in R/R KMT2Ar acute leukemia and plans to submit a BLA filing for axatilimab by year-end 2023.
NDA submission initiated for revumenib in R/R KMT2Ar acute leukemia under RTOR.
Final Phase 1 mNPM1 data from AUGMENT-101 demonstrates a 36% CR/CRh rate.
Revumenib and axatilimab U.S. registrational filings are on track for year-end 2023 completion and potential 2024 approvals.
Axatilimab to be featured in plenary session at 65th ASH Annual Meeting.
Forward Guidance
Syndax provided financial guidance for the full year of 2023.
Positive Outlook
- Research and development expenses are expected to be $160 to $165 million.
- Total operating expenses are expected to be $225 to $230 million.
- Guidance reflects a reduction from prior expectations.
- Company expects to complete the NDA submission for revumenib by year-end 2023.
- Company and Incyte expect to submit a Biologics License Application (BLA) filing for axatilimab by year-end 2023.
Historical Earnings Impact
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