Psychedelics

The high court sides with HHS on HIV PrEP drugs; Health Secretary RFK Jr.’s newly appointed CDC vaccine advisors discuss thimerosal in flu vaccines, skip vote on Moderna’s mRNA-based RSV vaccine; FDA removes CAR T guardrails; AbbVie snaps up Capstan for $1.2B to end first half; and psychedelics take off again with data from Compass and Beckley.

BPL-003 showed “robust” efficacy data in treatment-resistant depression, according to analysts from Jefferies, who noted that the asset could hit peak market sales of $1 billion. The results clear the way for the asset’s late-stage development and for the completion of a proposed merger with atai Life Sciences.

Mike Davis previously worked as clinical team leader at the FDA’s Division of Psychiatry before serving as chief medical officer for Usona Institute, a research organization advancing psychedelic science.

Although the company withheld detailed findings from the study of treatment-resistant depression, analysts at Stifel called COMP360’s efficacy “more than good enough” for registrational purposes.

In an interview on Friday, FDA Commissioner Marty Makary threw his weight behind psychedelic therapies, noting that patients taking these substances experience significant benefits for various neuropsychiatric conditions.

After the rejection of Lykos Therapeutics’ MDMA-based PTSD treatment tempered excitement for psychedelic therapeutics, a recent approval and positive data are generating new momentum, which experts expect to continue throughout 2025 and 2026.

In a Phase IIb trial, GH001 elicited significant drops in treatment-resistant depression. The news comes less than two weeks after J&J secured FDA monotherapy approval for its esketamine nasal spray Spravato in the same indication.

The results, which come on the heels of the FDA’s approval of J&J’s esketamine nasal spray Spravato as a monotherapy for treatment-resistant depression, could serve to further bolster a space hit hard by the rejection of Lykos’ MDMA-based PTSD therapy in August 2024.

Lykos Therapeutics is currently working out ways to fund an additional Phase III study for its MDMA-assisted PTSD therapy following an FDA setback last year.

Phase II results for Cybin’s psilocin therapy showed remission rates of 71%, but just eight patients made it to the 12-month milestone.