Psychedelics
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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.
On the heels of last week’s FDA rejection of Lykos’ MDMA-assisted PTSD therapy, Atai announced Tuesday positive preliminary results for its DMT-based treatment for depression from a Phase Ib study.
A day after the regulator denied approval of Lykos’ MDMA-assisted PTSD therapy, a medical journal pulled three studies related to the use of the psychedelic in the indication.
Clinical trial concerns and a negative advisory committee vote ultimately sunk the treatment.
With U.S. election season now in full swing, BioSpace looks at pharmaceutical-associated campaign contributions. Plus, Q2 earnings, Adaptimmune’s big approval, an anticipated FDA decision on an MDMA-assisted treatment and more.
The FDA has four big events in the coming two weeks, including an advisory panel meeting for an ultra-rare disease.
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