The Latest Breaking News from Lykos

Drugmaker Lykos Therapeutics announced on Aug. 9, 2024, that the Food and Drug Administration declined to approve the company’s application for the use of MDMA-assisted therapy in the treatment of post-traumatic stress disorder. It is the first such decision issued on a psychedelic drug application.

The FDA, which approved the protocols for the studies it now questions, is asking for an additional Phase 3 clinical trial, which would take years and millions of dollars.

Down 84% from all-time highs, Compass Pathways is a beaten-down biotech stock that trades at a massive discount to consensus price target estimates in 2024.

Military veterans have spent years lobbying for the use of psychedelic drugs to treat PTSD, but a sharply critical review of the club drug MDMA has put the therapy's approval in doubt

MindMed is a high-flying pre-revenue company that has more than doubled investor returns in the last 12 months.

FDA advisers this week will scrutinize what could become the first approved psychedelic drug.

Clinical trials of MDMA have been promising, but concerns have emerged about the quality of the research. A June hearing scheduled by the Food and Drug Administration is likely to address them.