Lykos Therapeutics said it had a “productive” meeting with the FDA to discuss a path forward for its recently rejected PTSD treatment, in the first public statement from the company since a tumultuous period following the drug’s rejection.
The company said the meeting between interim CEO Michael Mullette, Chief Medical Officer David Hough and the FDA “resulted in a path forward, including an additional Phase 3 trial, and a potential independent third-party review of prior Phase 3 clinical data.”
The company said that it will work with the agency on finalizing a plan for its drug, midomafetamine, better known as the psychedelic MDMA. The FDA rejected the drug in August, setting off a chain of events including severe layoffs and executive changes.
The brief readout of the meeting suggests Lykos isn’t likely to fight the FDA’s rejection of the drug. In September, Endpoints News reported that Lykos had planned to focus on fundraising to support an additional trial of the drug.
It’s not clear what result could come from an independent review of the company’s prior trials. Those studies faced questions about their conduct from an advisory board that voted overwhelmingly against supporting the company’s application.