Pharma is quickly warming to psychedelics

AbbVie’s $1.2 billion move to buy Gilgamesh’s psychedelic candidate is the first time a traditional drugmaker has snapped up an investigational psychedelic — a milestone that analysts say could trigger a wave of follow-on deals, STAT’s Olivia Goldhill writes.

“There’s a huge amount of interest coming in suddenly from pharma,” said Josh Hardman, founder of the media and consulting firm Psychedelic Alpha. “We’ve seen a huge uptick in the last six months of larger pharma companies joining the mailing list, taking out paid subscriptions.”

With Janssen’s esketamine nasal spray Spravato racking up $780 million in 2024 sales, pharma is eyeing Compass Pathways, Beckley Psytech, and others advancing Phase 2 and 3 studies. Likely suitors include Otsuka, Johnson & Johnson, and Lundbeck, while even cautious giants like Novartis and Roche are circling. The message: Psychedelics are shifting from fringe science to mainstream pharma opportunity.

painkillers

FDA pushing non-opioid path for chronic pain

The Food and Drug Administration yesterday issued draft guidance to accelerate development of prescription non-opioid treatments for chronic pain, aiming to reduce reliance on opioids still prescribed to one in five U.S. adults with the condition. The document lays out expectations for Phase 3 trial design, safety, and labeling, and ties directly to the SUPPORT Act of 2018.

It follows the agency’s approval this year of Journavx, made by Vertex Pharmaceuticals, the first-in-class non-opioid for acute pain. It also underscores a broader federal push under HHS Secretary Robert F. Kennedy Jr. to expand alternatives as the opioid epidemic persists. Public comment will remain open for 60 days.

“America’s opioid crisis is not over. We must stay vigilant to address this longstanding problem in new ways. Physicians need more alternatives to opioid medications for patients suffering from chronic pain,” FDA Commissioner Marty Makary said in a statement. “FDA can help by providing clear guidance like this, which makes regulatory pathways more predictable for innovators and drug developers, enabling effective, lower-risk therapies to quickly reach the millions of Americans living with chronic pain.”

lung cancer

Some questions about Soon-Shiong's Anktiva claims

Billionaire physician Patrick Soon-Shiong is proclaiming the success of ImmunityBio’s Anktiva, but new Phase 2 data in lung cancer fall short of supporting his bold survival claims, STAT’s Adam Feuerstein writes.

Anktiva is already approved for bladder cancer, but its commercial uptake is weak, and Johnson & Johnson just won approval for a rival drug. While Anktiva could prove beneficial if ongoing Phase 3 trials succeed, Adam writes that Soon-Shiong’s sweeping claims oversell the existing data.

Gene Therapy

Child dies after receiving experimental gene therapy

The first child to receive an experimental gene therapy for a rare neurological disorder died a few days after dosing, the company sponsoring that trial said Wednesday.

The company, Capsida Biotherapeutics, is one of a group of companies and labs engineering new viruses potentially capable of safely ferrying genes deep into the brain. Its first effort was designed to treat STXBP1 encephalopathy, a condition that can cause seizures, developmental delays, and other symptoms.

The STXBP1 Foundation said in a note to community members that the company and investigators were still working to understand what happened.

“Our deepest love and condolences are with the family, and we ask everyone to honor their privacy during this profoundly difficult time.” they wrote. “We know that waiting for answers is incredibly hard and that everyone wants to find out what happened.”

europe

Merck retreats from London hub amid U.K. drug row

Merck is abandoning a $1.3 billion London research center and vacating its space at the Francis Crick Institute — cutting 125 jobs — in part because of what it sees as Britain’s unwillingness to pay higher prices for innovative drugs. The move underscores pharma’s frustration with U.K. policies, STAT’s Andrew Joseph writes, as rebate rates on new medicines have surged and companies warn they may skip launches entirely.

Specifically, Merck said in a statement that this move “reflects the challenges of the U.K. not making meaningful progress towards addressing the lack of investment in the life science industry and the overall undervaluation of innovative medicines and vaccines by successive U.K. Governments.”

The pullback follows AstraZeneca’s scrapped vaccine investment near Liverpool and adds to fears that the U.K.’s ambitions to be a life sciences hub are colliding with its cost-containment strategy.