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Good morning, the FDA’s recent rejection of an MDMA therapy hasn’t seemed to deter some other companies from moving ahead with psychedelics studies. We discuss that, and also some big policy developments that are coming this week.
Atai advances oral psychedelic in depression
From STAT’s Meghana Keshavan: The FDA may have recently rejected MDMA-assisted psychotherapy, but other players in the psychedelics space are moving ahead with candidates. Atai Life Sciences this morning reported early data from its Phase 1b trial testing an oral form of the psychedelic DMT for treatment-resistant depression.
The drug, VLS-01, is meant to induce a quick psychedelic experience, so that patients only stay at the clinic for about two hours. Patients described the experience as “psychologically meaningful” and with “increased levels of self-reflection,” Atai said. The trial was not designed to study efficacy; Atai will look at that in a Phase 2 trial planned to start later this year.
Beyond DMT, Atai CEO Srinivas Rao said in an interview that the company is developing a version of MDMA that has a different pharmacological profile than the MDMA that is commonly available today.
“MDMA is very externally focused, linked to sociability and affiliative behaviors — and that’s why it’s a drug of abuse,” Rao said. “Our MDMA is a much more inward-facing thing — so we don’t have the same issues.”
First negotiated Medicare prices could come this week
Watch pharma stocks on Thursday, when the Biden administration is expected to announce, before markets open, the prices of the first 10 drugs selected for Medicare bargaining under the Inflation Reduction Act, according to reporting by Politico.
Pharma companies have continued to rail against the IRA, arguing that Medicare is not “negotiating” prices, but rather setting them. But they’ve also said that the prices that have been arrived at in this first round, which will go into effect in 2026, will be manageable for them.
Vasant Narasimhan, CEO of Novartis, whose heart failure drug Entresto was selected, said on a recent earnings call that “in the short-term this might be manageable on our first set of drugs. In the long run, this policy is really not good for innovation, good for patients in the United States,” according to a transcript produced by AlphaSense.
Jennifer Taubert, head of J&J’s pharmaceuticals business, said on an earnings call that the final prices have been included in guidance that the company previously disclosed and that the guidance still looks “very consistent today.” J&J has three drugs selected — its blood thinner Xarelto, its anti-inflammatory drug Stelara, and its blood cancer treatment Imbruvica.
We’ll see who actually got the better end of the negotiations when the numbers are announced. For the list of the first 10 drugs selected, go here. And for more on how to assess the final prices, check out this story from a couple of weeks ago by my colleague John Wilkerson.
Pfizer taps Nvidia alum to lead AI work
Pfizer has recruited a former Tesla and Nvidia engineer to be the company’s chief AI and analytics officer, according to a LinkedIn post by Lidia Fonseca, Pfizer’s chief digital and technology officer.
The new AI head, Berta Rodriguez-Hervas, was most recently a vice president at automaker Stellantis focused on autonomous vehicles.
The hire points to an effort by Pfizer to identify new growth drivers as it faces declining sales of its Covid-19 products. Amid these pressures, the company’s long-time chief scientific officer, Mikael Dolsten, recently announced that he will soon be stepping down.
Increasingly more drugmakers have been employing AI in drug discovery, partnering with large tech companies including Microsoft, Nvidia, and Alphabet. But while it seems like AI may help speed up the discovery process, the technology is still far from producing major breakthroughs and cures.
For more on the challenges of using AI in drug discovery, check out this story my colleague Casey Ross did earlier this year.
It’s hard to compete with Botox
Revance Therapeutics, maker of an anti-wrinkle treatment that rivals Botox, said yesterday that it’s agreed to be bought by skincare company Crown Therapeutics for $924 million. This represents an 89% premium to Revance’s closing price last Friday.
The deal follows a rough launch for Revance’s treatment, called Daxxify. The company initially priced Daxxify higher than Botox, as it has longer-lasting effects, but Revance struggled to draw customers and eventually cut the price. The stock has struggled, falling about 60% this year before yesterday when the deal was announced.
More reads
- Big drugmakers are clinching smaller deals, Wall Street Journal
- Pressure from anti-China legislation begins to ripple through biopharma, Endpoints
- Why U.S. health care cybersecurity laws are better at protecting a corpse’s privacy than patients’ lives, STAT