Revumenib Updates
- NDA Submission: Syndax submitted a New Drug Application (NDA) for revumenib, targeting adult and pediatric relapsed or refractory (R/R) KMT2A-rearranged (KMT2Ar) acute leukemia, under the FDA's RTOR program.
- AUGMENT-101 Trial: Enrollment in the AUGMENT-101 pivotal trial for R/R mutant nucleophosmin (mNPM1) acute myeloid leukemia (AML) is expected to complete by late Q1 or early Q2 2024, with topline data anticipated in Q4 2024.
- Clinical Trials Expansion: Syndax is expanding trials to validate the recommended Phase 2 dose for revumenib, with additional data expected in the second half of 2024.
Axatilimab Updates
- BLA Submission: A Biologics License Application (BLA) for axatilimab in chronic graft-versus-host disease (cGVHD) was submitted to the FDA.
- Co-Commercialization Agreement: Syndax exercised its option to co-commercialize axatilimab in the U.S. with Incyte.
- Phase 2 Trial for IPF: A Phase 2 trial assessing axatilimab's efficacy in idiopathic pulmonary fibrosis (IPF) is now open for enrollment.
Corporate and Financial Updates
- Follow-On Offering: Syndax completed a $230 million follow-on offering in December 2023, extending its cash runway through 2026.
Syndax Pharmaceuticals continues to advance its innovative pipeline of cancer therapies, with revumenib and axatilimab at the forefront of its development efforts. The company's strategic milestones and financial stability underscore its commitment to delivering meaningful clinical benefits to patients with cancer and fibrotic diseases.
