SNDX - Syndax Pharmaceuticals: Upcoming Q3 PDUFAs Ignite Hope

2024-03-28 07:54:58 ET

Summary

• Syndax Pharmaceuticals has two lead molecules in line for FDA review: revumenib for the treatment of acute leukemia and axatilimab for chronic graft-versus-host disease.
• Syndax is a speculative buy for those willing to take a risk on the FDA approval process.
• The approval and launch of revumenib in 2024 and the axatilimab deal with Incyte are important milestones to watch.

This is my first take on Syndax Pharmaceuticals ( SNDX ) a development stage pharma with two lead molecules in line for FDA review:

1. 01/02/2024 — revumenib in treatment of adult and pediatric relapsed or refractory (R/R) KMT2A-rearranged (KMT2Ar) acute leukemia, NDA submitted under FDA's Real-time Oncology Review program [RTOR], accepted for filing with an 09/26/2024 PDUFA;
2. 02/27/2024 — Incyte ( INCY ) announced an 08/28/2024 PDUFA on its axatilimab BLA, being developed with Syndax for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy.

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