On Vinay Prasad's brief, chaotic tenure at the FDA

Vinay Prasad's short and turbulent tenure at the FDA is ending the way much of it unfolded — in controversy.

In a new column, STAT's Matthew Herper says that Prasad, whose upcoming departure from the agency was announced late Friday, was right that the FDA needed to demand stronger evidence before approving certain drugs, particularly in rare diseases. But his approach often caused chaos.

Prasad frequently escalated disputes that could have been resolved through normal regulatory channels, Matt says, and as STAT has reported, he overruled staff and alienated colleagues. His confrontational style, public fights with companies like Moderna, and controversial claims about vaccine safety also undermined his credibility.

Read more on Matt's five lessons from the short-lived Prasad era.

FDA

Wall Street is also rendering a verdict on Prasad's departure

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From my colleague Adam Feuerstein: Gene therapy and rare disease drug stocks are trading higher in the early Monday session. UniQure, which may now have a path open for the filing of its Huntington's disease treatment, rose 35%. RegenxBio, which saw its gene therapy for MPS II rejected by Prasad's FDA center, was up 10%. Capricor Therapeutics rose 12%; Atara Biotherapeutics was up 22%.

"We see the departure of Dr. Vinay Prasad from CBER as the most significant news out of FDA this year, potentially driving an impactful shift in the agency's regulatory culture from the last year of chaos. We see an improved regulatory outlook for names with complex therapies working in challenging, rare indications and expect a boost to a number of stocks in our coverage as a result," said Baird biotech analyst Brian Skorney, in a note to investors Monday.

FDA Commissioner Marty Makary is in Miami this week speaking to health care investors attending a slew of broker conferences, noted Mizuho health care strategist Jared Holz. That should make for some interesting, perhaps awkward, conversations.

It took about 15 seconds for former FDA official Rick Pazdur's name to rise to the top of the list of potential Prasad replacements. Whether that's wishful thinking or a real possibility remains to be seen, but Pazdur is also in Miami. He spoke to an overflow room of investors on Sunday night at the Leerink Partners health care conference, sounding very much like a guy whose long, distinguished FDA career was interrupted, but not finished.

"Will [Prasad's replacement] be someone with actual regulatory experience or a regulatory track record?" writes Stifel biotech analyst Paul Matteis, in a note this morning. "Our gut is that the Trump administration — with the midterms coming and the FDA on the radar of Congress — won't want someone controversial, especially on vaccines. More to come, but one would think this all leads to FDA being more industry friendly."

biotech

A strong Phase 3 trial for Xenon's epilepsy drug

An experimental seizure drug called azetukalner made by Xenon Pharmaceuticals met the main goal of a Phase 3 trial in patients with focal onset seizures. It cut monthly seizure frequency by 53% compared with 10% for placebo over 12 weeks — results that seem to be stronger than results from the company's earlier Phase 2 study, STAT's Adam Feuerstein writes.

Xenon plans to file for approval with the FDA in the third quarter.

The therapy works through a Kv7 potassium channel mechanism not used by existing treatments. Beyond epilepsy, Xenon is also testing azetukalner in major depressive disorder and bipolar depression, which are far larger markets.

regulation

FDA's sidelining of advisory panels draws criticism

The FDA is increasingly avoiding its traditional advisory committee meetings — the public forums where regulators, outside experts, companies, and patients debate controversial drug decisions. Instead, it's communicating through anonymous briefings and private channels, STAT's Lizzy Lawrence reports.

The shift has alarmed many in drug development and patient communities, who say the meetings provided transparency and a rare chance to see the scientific disagreements behind regulatory decisions. The process also allows agency leaders, drug developers, patients, and physicians to speak their minds in public.

Advisory committees have dropped sharply, from 38 in 2024 to just 14 last year. The shift comes as the agency contends with constant leadership turnover and staffing cuts.

Cancer

A setback for Roche's breast cancer drug

From my colleague Andrew Joseph: Roche's high hopes for its breast cancer drug giredestrant — executives have said it could be the company's best-selling product ever — took a hit this morning, as the company reported that a combination of the treatment and another medicine failed to outperform the current standard approach in a first-line setting.

Roche shares were down about 5% in Switzerland.

The Swiss pharma giant has already submitted giredestrant to the FDA based on data from a positive Phase 3 study in later-line settings, and said it will file additional data with regulators in the coming weeks based on another positive study testing giredestrant in an adjuvant setting. But the outcomes of the persevERA trial toplined Monday could limit the pill's label.

The study tested giredestrant together with Pfizer's Ibrance versus an available combination as a first-line approach in patients with ER-positive, HER2-negative advanced or metastatic breast cancer. Roche said there was a numerical improvement in progression-free survival with its drug, but the results were not statistically significant.

Roche noted that it has another trial testing giredestrant in a first-line setting in a different group of breast cancer patients called the pionERA study, with data expected next year.

"While persevERA didn't meet its primary objective, we are confident in the potential of giredestrant to become a new standard-of-care endocrine therapy in early and advanced ER-positive breast cancer," Levi Garraway, Roche's chief medical officer, said in a statement.

glp-1 drugs

Generic semaglutide could cost just $3 a month

Generic versions of the blockbuster obesity and diabetes drugs Wegovy and Ozempic could theoretically be produced for as little as about $3 per person per month once patents expire in several countries this year, according to a new analysis.

With patents expiring soon in countries including India and China — where dozens of generic manufacturers operate — the authors argue that low-cost production could dramatically expand access in lower-income countries, where obesity and diabetes are widespread but treatments remain unaffordable, STAT's Ed Silverman writes.

"Semaglutide is not just a cosmetic treatment — obesity and diabetes are chronic diseases that increase the risk of stroke, heart disease, kidney failure, and cancer," said Samuel Cross, a co-author and physician at Imperial College London. "If generic production reduces prices to sustainable levels, millions more people could access treatment."