Psychedelics

FDA extends its review of Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy as an unhappy shareholder advocates for change; Merck and Moderna tout positive data for their mRNA-based cancer vaccine; Trump nominates White House aide Heidi Overton as FDA commissioner; and the oral obesity market heats up with rivals Eli Lilly and Novo Nordisk going head-to-head.

Companies that manufacture MDMA and psilocybin for patients in other countries are looking to use their experience to access the potential U.S. market.

It’s smooth sailing for Definium Therapeutics as the psychedelic biotech charts another win for its LSD candidate, this time in anxiety. The psychedelic previously notched a late-stage victory in depression.

Definium Therapeutics’ closely watched anxiety readout could further validate its single-dose LSD candidate, while Compass Pathways advances a psilocybin program through a rolling FDA filing.

While there are several FDA-approved psychiatric medicines on the market, many patients still struggle to achieve lasting symptom relief. Psychedelics could help fill this gap.

In this episode of Denatured, you’ll hear from Hans Eriksson, chief medical officer at FundaMental Pharma and Steve Levine, chief patient officer at Compass Pathways. We explore why treatment-resistant depression remains so difficult to address, and how new approaches—from rapid-acting antidepressants to psychedelic therapy—may reshape the treatment paradigm.

Eli Lilly’s $3.8 billion play for AtaiBeckley has fueled speculation that Big Pharma is ready to embrace psychedelics. But while the acquisition does validate the drug class, analysts say it is unlikely to trigger a broad wave of Big Pharma deals.

Second quarter earnings continue to roll with Novartis and Roche reporting this week; Eli Lilly’s AtaiBeckley buy for up to $3.8 billion offers clear “validation” for the fledgling psychedelics space; more drama unfolds at FDA as the agency goes back and forth on its policy of publishing complete response letters in real-time; and IPO fever continues.

Eli Lilly’s proposed acquisition of AtaiBeckley is “the clearest strategic validation to date” of psychedelics as an emerging pharmaceutical category, according to H.C. Wainwright. The analyst cautioned, however, that the transaction should not be seen as “supporting a uniform re-rating of every psychedelic developer.”

With the AtaiBeckley acquisition, Eli Lilly is jumping into psychedelics, a drug class that Jefferies analysts say could herald the “biggest change” for the field of psychiatry.