PharmAla says ALA-002 patient dosing is unlikely in 2026 as finished GMP drug product remains in development

PharmAla CEO Nick Kadysh said ALA-002 is unlikely to be dosed in patients during 2026 because its finished GMP drug product is still being developed. The active drug substance was completed in July, but Corealis Pharma only began formulation work in November, with release expected between December and February. ALA-002 is a patented non-racemic MDMA-derived candidate that PharmAla initially plans to develop as a 50 mg capsule. Release of a batch would not immediately enable dosing: clinical sites, regulatory authorization and ethics approval would still be required, and no ALA-002 trial was registered in the databases searched on November 6. Under PharmAla's U.S. license with Jupiter Neurosciences, development deadlines are tied to finished-dose inventory, although no supply agreement, U.S. trial plan or timetable has been disclosed. A conditional calculation places a potential IND deadline around June to August 2027 if the stated release window holds.