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Mar 31, 2024
Syndax Q1 2024 Earnings Report
Syndax reported first quarter 2024 financial results and provided a business update.
Key Takeaways
Syndax Pharmaceuticals reported its financial results for the quarter ended March 31, 2024. The company highlighted the potential near-term approvals of revumenib and axatilimab, as well as pivotal data expected from the AUGMENT-101 trial in the fourth quarter. The company had cash, cash equivalents, and short and long-term investments of $522.0 million as of March 31, 2024.
NDA filing for revumenib in R/R KMT2Ar acute leukemia granted Priority Review under RTOR with a PDUFA action date set for September 26, 2024.
BLA filing for axatilimab in chronic GVHD granted Priority Review with a PDUFA action date set for August 28, 2024.
Enrollment completed in AUGMENT-101 mNPM1 cohort; topline data expected in 4Q24 to potentially support sNDA filing in 1H25.
Company to host conference call today at 8:00 a.m. ET.
Forward Guidance
For the second quarter of 2024, the Company expects research and development expenses to be $50 to $55 million and total operating expenses to be $80 to $85 million. For the full year of 2024, the Company continues to expect research and development expenses to be $240 to $260 million and total operating expenses to be $355 to $375 million, which includes an estimated $43 million in non-cash stock compensation expense. The Company believes that it has sufficient cash runway to fund its research, clinical development and commercial operations through 2026.
Historical Earnings Impact
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