November 11, 2025

The need-to-know this morning

Soleno Therapeutics is repurchasing $100 million of its own stock to demonstrate confidence in the early commercial launch of Vykat XR, its treatment for Prader-Willi Syndrome, the company said.
enGgene Holdings said its localized gene therapy induced a complete response in 62% of patients with a type of bladder cancer, measured at six months. The company plans to report 12-month data in the second half of next year, and if positive, seek regulatory approvals.

biotech

Chinese government's support for biotech fuels huge rally

Chinese biotech stocks have been surging. While the most closely tracked U.S. index of biotech stocks is up more than 20% this year, the Hang Seng Biotech Index, which tracks the 30 largest biotech firms in Hong Kong, has climbed more than 80%.

Dozens of biotech firms are now reviving IPO plans in Hong Kong and Shanghai.

Fueling this rally is not only investor enthusiasm, but also immense support from Beijing and provincial governments. Last year, the State Council, effectively the country's cabinet, outlined the first national policy framework to connect every stage of drug development to accelerate domestic innovation.

At the local level, the city of Wuxi, for example, earmarked some $1.3 billion to support biopharma manufacturing, deal-making, and clinical services last year.

Read more from STAT contributor Liyan Qi.

pharma

Will Pfizer's $10 billion bet on Metsera pay off?

Pfizer has claimed victory in its bidding war against Novo Nordisk to acquire Metsera for up to $10 billion. But in doing so, the company has also taken on significant risks.

Much is riding on whether, as Pfizer hopes, Metsera's drug candidates will demonstrate strong efficacy when dosed monthly, and also whether monthly dosing would give the treatments a big enough advantage to stand out in the increasingly competitive obesity market.

"If the whole thing fails, then we overpaid. If the whole thing succeeds, then it's a fucking good deal," Pfizer CEO Albert Bourla said in an interview with CNBC yesterday.

deals

What Pfizer's deal tells us about biotech M&A

Pfizer and Novo's bidding war also offers some lessons on dealmaking for the industry at large, my colleague Matt Herper wrote.

Among other things, he noted, it showed that the FTC under the Trump administration is closely watching big deals. Metsera's board determined the regulatory risks of going with Novo's offer were too high after it received a call from the FTC. It's not clear if the agency was responding to concerns expressed by Pfizer, or for some other reason, but the agency is nevertheless clearly willing to step in.

Read on for the other takeaways.

regulation

FDA to remove black box warning on menopause therapies without ad comm meeting

The FDA yesterday said it's reversing a 2003 decision that put a black box warning on hormone therapy products for menopausal women, saying that the treatments offer heart, brain, and bone health benefits.

While many doctors have long advocated for the FDA to remove the warning, some clinicians were concerned that the agency didn't follow the traditional process to make this decision. The FDA convened an expert panel to discuss hormone therapies, but it was a short and relatively informal conversation, not a traditional advisory committee with subject matter experts to review new safety data.

When asked at a press conference why the agency didn't host an ad comm Makary said it was because "ad comms are bureaucratic, long, often conflicted, and very expensive."

Read more from STAT's Theresa Gaffney and Chelsea Cirruzzo.

Under Makary, the FDA has been convening fewer ad comms than under previous leadership. Makary seems to be shifting instead toward discussing regulatory ideas through podcasts or informal roundtables, Politico wrote earlier this year.

More around STAT