JP Morgan, mifepristone, Cabaletta Bio news

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Good morning. We’ve reached the end of the week! Let’s keep it short and go straight to the news of the day.

The must-know this morning

• Cabaletta Bio presented early data on an experimental CD-19 targeting CAR-T therapy for autoimmune diseases at a European rheumatology meeting.

The industry welcomes the Supreme Court’s ruling on the abortion pill

Biopharmaceutical leaders yesterday cheered the Supreme Court’s ruling that anti-abortion doctors did not have standing to challenge the FDA’s regulation of the abortion pill mifepristone.

The industry had warned that a decision in favor of the plaintiffs could have destabilized the drug approval process. Last year, after a federal judge in Texas suspended the FDA’s approval of mifepristone, hundreds of biopharmaceutical executives and leaders signed an agreement open letter blasting the decision, saying it created uncertainty for the entire industry, which depends on the agency’s autonomy and authority to bring new drugs to market.

We contacted some of these people following yesterday’s Supreme Court ruling:

John Maraganore, former biotechnology executive and investor, said: “This is a huge victory for the FDA and its authorities, for science and the importance of evidence over religious beliefs, and for women and their rights. Thank God!”

Daphne Zohar, CEO of Seaport Therapeutics, said: “The decision ensures that patients and drug developers can rely on the FDA’s rigorous approval process as the scientific and trusted standard for drug approvals.”

Read more about how other industry leaders responded.

And of course, FDA Commissioner Robert Califf was happy with the decision. It seems he heard about it when he got a call during a live-streamed FDA meeting (which we’ll discuss below): “Okay! How are you! We have good news,” he exclaimed.

FDA receives sharp criticism from the advisory committee

From STAT’s Meghana Keshavan: It was all a bit meta – yesterday the FDA convened an advisory committee to shake up advisory committees. While these expert meetings have played a crucial role in helping regulators decide whether a drug or device deserves approval for more than 50 years, observers say there is room for improvement. FDA Commissioner Robert Califf kicked off the hours-long public debate on how to make these committees better.

Advocates spoke passionately about how patients’ voices should be better heard and better represented during these panels. And there have long been concerns that conflicts of interest among committee members are rampant.

Read more.

Setback in Duchenne therapy, an approval for Alzheimer’s drugs and buying weed for journalism

This week on “The Readout LOUD,” we talk about Pfizer’s Duchenne gene therapy setback, the likely approval of Lilly’s Alzheimer’s treatment, and Bob Langer’s latest startup.

We also reach out to STAT’s commercial determinants of health reporter, who, instead of constantly working at his desk, often drives around town buying things like weed, vapes, and raw milk — all in the name of good journalism.

Listen.

JP Morgan has officially moved into early-stage biotech investing

From STAT’s Allison DeAngelis: JP Morgan Life Sciences Private Capital, a small team within the investment banking giant, closed its first fundraising, raising more than $500 million to invest in life science startups. announced yesterday.

JP Morgan had launched its life sciences private capital team in late 2022, hiring Regeneron and Alexion Pharmaceuticals co-founder Stephen Squinto to lead the group. What does the team want to invest in? Obesity therapies, of course, along with treatments for cardiometabolic diseases, immune-related conditions and more.

Notably, the group will start and incubate new biotech companies, a model that venture capital firms generally struggle to execute, Squinto told STAT in 2022. “It’s very easy to write a check and get a business launched. It’s harder to navigate the early stages of building a business,” he previously said. “I honestly don’t think there are many companies that do that so well.”

Read more

• As the MDMA debate spreads beyond biotech, Lykos CEO takes a look at efficacy, safety concerns, Fierce biotechnology
• Versant debuts biotech working on ‘anger management for the immune system,’ Biopharma dive
• Telehealth startup Done’s top leadership arrested on fraud charges, STAT
• Global healthcare leader criticizes ‘incompetence’ of US response to bird flu outbreak in cows, STAT