Two Syndax drugs may receive FDA approvals later this year in graft v host & leukemia | $SNDX

Apr 22, 2024

∙ Paid

SUMMARY

Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) ran into a surprising headwind last October after it announced topline phase II data for revumenib to treat acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL). While the data revealed revumenib met the primary endpoint impressively, investors were unenthused and sent the stock downward by 7%. The trial’s results hinted of safety concerns and doubts arose about how well revumenib would compete with Kura Oncology Inc.’s (NASDAQ:KURA) ziftomenib.

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The company rebounded and, as promised in October 2023, Syndax submitted an NDA for revumenib to treat relapsed/refractory KMT2A-rearranged (KMT2Ar) AML patients tested in the phase II trial. The phase II data for revumenib in biomarker-specific KMT2Ar AML patients was superior to the data reported in the ALL cohort. The FDA subsequently accepted the NDA to treat KMT2Ar patients. Syndax estimates the KMT2Ar patient population at 2,600 US patients. Syndax also submitted an NDA last year for a second drug, axatilimab (AGAVE-201), to treat chronic graft versus host disease (cGvHD). The FDA accepted the revumenib and axatilimab NDAs in early 2024.

Key catalysts

PDUFA decision for axatilimab (AGAVE-201) to treat chronic graft versus host disease (cGvHD)
PDUFA decision for revumenib to treat adult and pediatric KMT2Ar leukemia