Biography/Memoir

After FDA setback, psychedelic drugmakers distance themselves from a pioneer

A resoundingly negative vote by an advisory committee to the Food and Drug Administration on Tuesday [6/5/24] – though not binding – has diminished the chances of the sponsor, Lykos Therapeutics, from winning full approval for MDMA to treat post-traumatic stress disorder, industry observers said. But biotech executives, investors and researchers said in interviews that their enthusiasm for psychedelics to treat mental health disorders remains undimmed. They are betting that a by-the-books clinical trial design run by a more conventional drugmaker will ultimately succeed.

Kabir Nath, chief executive of Compass Pathways, said the vote was an opportunity to “pivot away from some of the, shall we say, psychedelic baggage,” referring to misconduct allegations. Compass is developing a synthetic form of psilocybin, a chemical found in hallucinogenic mushrooms, for severe depression. After Lykos, Compass Pathways is the next closest psychedelic developer to seeking FDA approval. Unlike Lykos, the company is not pairing its drug with psychotherapy. Investors saw the advisory panel vote as potentially negative for the whole category of drugs, however. Compass saw its stock drop by 15 percent the day after the vote, before rebounding to close down 2.6 percent. Shares of Mind Medicine, which is testing a form of LSD, and Atai Life Sciences, which is investing in psilocybin and DMT, fell 10 percent and 8.4 percent, respectively.

Original Article (Washington Post):
After FDA setback, psychedelic drugmakers distance themselves from a pioneer
Artwork Fair Use: Public Domain

Biography/Memoir

Patented…

Biography/Memoir

…launch of…