One of the biggest stories of last year was Lykos Therapeutics’ failure to get its MDMA candidate over the finish line for post-traumatic stress disorder (PTSD). But the biotech has reminded us this week that it hasn’t given up hope yet.
When the FDA turned down Lykos’ application for approval for its MDMA capsule along with psychological intervention, also known as MDMA-assisted therapy, in August 2024, the regulator explained that it could not approve the treatment based on the data submitted to date. Instead, the agency requested that Lykos run another phase 3 trial to further weigh the efficacy and safety of MDMA-assisted therapy for PTSD.
Initially, Lykos argued that conducting a further late-stage study “would take several years” and pledged to meet with the FDA to ask the agency to reconsider its decision. But, by October, the biotech had come around to the decision.
In a post-market statement on Jan. 16, Lykos gave a fresh update following what it described as a “productive” meeting with the FDA on Wednesday.
“We continue to chart a path forward for an independent third-party review of prior phase 3 clinical data and an additional phase 3 trial,” the company said.
The meeting with the FDA was designed to get feedback on the independent review plan Lykos has proposed. The plan “continues to proceed on track,” Lykos explained.
The brief update didn’t offer any details of the timeline for the MDMA therapy’s second shot at approval. The company shed around 75% of its staff last year in the wake of the FDA’s rejection.