Psychedelics
Phase II results for Cybin’s psilocin therapy showed remission rates of 71%, but just eight patients made it to the 12-month milestone.
In another delay for the psychedelic treatment space, Compass Pathways announced adjusted timelines for two Phase III trials of its psilocybin to address treatment-resistant depression.
In a short statement Friday, Lykos Therapeutics expressed optimism about a recent meeting with the regulator to discuss next steps for the embattled program, following the FDA’s rejection in August 2024.
Massachusetts residents voted Tuesday against the Natural Psychedelic Substances Act, which would have seen some psychedelics, including psilocybin and dimethyltryptamine, legalized in the state.
After the FDA declined to approve Lykos Therapeutics’ MDMA-assisted therapy for post-traumatic stress disorder, companies are pivoting away from or delaying similar therapeutics targeting the psychiatric disease.
Amy Emerson is stepping down on the heels of the FDA last month rejecting Lykos Therapeutics’ MDMA-based therapy for post-traumatic stress disorder and the company laying off three-quarters of its staff.
Last week, the Biden administration revealed the first drug prices negotiated under the Inflation Reduction Act; Lykos, Grail and others make substantial staffing cuts, and Pfizer/BioNTech see mixed results for their COVID/flu vaccine.
Psychedelic drug developers are undeterred by the FDA’s Complete Response Letter for the company’s MDMA therapy for PTSD, and experts expect Lykos will ultimately obtain approval.
Lykos will lay off approximately three-quarters of its staff amidst a reorganization aimed at helping the company complete a regulatory resubmission for its MDMA-assisted therapy.
Lykos Therapeutics will ask the FDA to reconsider its rejection of the company’s MDMA-assisted PTSD therapy, Pfizer scores positive Phase III results for its RSV vaccine, a roundup of Q2 earnings season and more.
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