Syndax Pharmaceuticals (NASDAQ:SNDX) Inc (Syndax Pharmaceuticals (NASDAQ:SNDX)) stock was on the back foot on Monday, after reporting results from a leukaemia drug trial that met its primary endpoint.
"We are thrilled to report positive results for revumenib in KMT2Ar acute leukaemia that demonstrate the utility of its practice-changing clinical profile and highlight revumenib's potential as a first- and best-in-class agent," chief executive Michael Metzger said.
"Breakthrough Therapy Designation has enabled us to work closely with the FDA to submit an NDA by year-end.
“Enrollment in the mNPM1 cohort of AUGMENT-101 is also progressing well, and we are rapidly advancing that program to an anticipated filing following KMT2Ar.
“Syndax is funded into the second half of 2025, including through multiple key milestones and both product launches in 2024, which will put us on a clear path to realize the full blockbuster potential of revumenib and axatilimab."
In New York, Syndax shares were down 8.5% changing hands at $13.28.
The trial comprised 94 acute leukemia patients, revumenib was well tolerated and consistent, the company noted.