Syndax hit by menin delay

Syndax Pharmaceuticals might still become the first company to get a menin inhibitor approved, but the path to market for its contender, revumenib, is looking less smooth than it was. Today the group disclosed a three-month delay to the project’s PDUFA date, pushing an FDA approval decision back to late December. There wasn’t much to go on: Syndax said the agency needed more time to review supplemental information provided on the FDA’s request; without knowing the nature of these requests, it’s hard to say whether this will hurt revumenib’s chances of a nod in relapsed/refractory KMT2A rearranged acute leukaemia. Syndax did say that no additional trials or manufacturing information have been requested by the FDA, but its shares still opened down 14% this morning. Some backers had likely hoped for approval ahead of the original 26 September PDUFA date, given revumenib is being assessed under the FDA’s real-time oncology review programme. One concern could be toxicity, with menin inhibitors associated with with QTc prolongation, differentiation syndrome and neutropenia. Meanwhile, a menin inhibitor battle in relapsed/refractory NPM1-mutant AML is shaping up, with Syndax set to report pivotal data here just ahead of its main menin rival, Kura Oncology.

Menin inhibitors race for approval

Note: *Kura stopped monotherapy development in KMT2Ar AML in Feb 2023. Source: OncologyPipeline, clinicaltrials.gov & company releases.