March 7, 2024

The need-to-know this morning

Novo Nordisk's experimental oral GLP-1 drug, amycretin, delivered promising early results, leading to a 13.1% loss of body weight in a 12-week study without notable new side effects. That compares to a 14.7% weight reduction for Eli Lilly's oral GLP-1, orforglipron, in a Phase 2 study that lasted 36 weeks and a 5% reduction in weight in a 12-week study for Structure Therapeutics' entrant. Current GLP-1s, which are the most in-demand class of medicines to emerge in years, are injections. Creating oral drugs could dramatically expand an already large market.

Biotech

The next test of FDA flexibility

It belongs to Applied Therapeutics, whose lead drug, for the rare disease galactosemia, is up for an FDA decision based on a study that didn't meet its primary endpoint but, according to the company, showed enough promise to merit approval.

As STAT's Adam Feuerstein writes, Wall Street has warmed up to Applied's case. Its shares traded below $1 in 2022, and it had a market cap of less than $200 million until earlier this year. Then, Applied's stock price more than tripled in recent weeks after numerous biotech hedge funds disclosed stakes in the company.

Their bet is in part based on FDA kremlinology. Applied's drug falls under the agency's Office of Rare Drugs, which was run by a regulator with a reputation for conservatism. Last year, she got replaced by another FDA official who, at least according to investors, is likely to be more receptive to Applied's application.

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Washington

Biden wants to expand pricing negotiation

President Biden wants to significantly expand a new program that allows Medicare to negotiate certain drug prices, and he's going to use tonight's State of the Union address to make his case.

As STAT's Rachel Cohrs reports, the current program will eventually allow Medicare to negotiate the prices of up to 20 drugs per year, and Biden wants to push that number to 50, bringing more medicines into the negotiation process sooner.

This won't be welcome news for the pharmaceutical industry, which has already challenged the initial policy in a series of so-far-unsuccessful lawsuits. But actually amending the law would require Biden persuading Congress, which is deeply unlikely with the House in Republican control.

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Markets

Biotech IPOs are back on the rise

The latest filing comes from Boundless Bio, seeking to become the seventh biotech company to successfully go public in 2024 amid a resurgence of IPOs in the sector.

Boundless, headquartered in San Diego, is developing drugs aimed at the rings of DNA found in tumors but absent from healthy cells. Roughly 15% of cancers have that so-called extrachromosomal DNA, and Boundless' lead drug is designed to block the biological process that produces it.

The company didn't disclose how much it intends to raise or its expected valuation. Boundless' lead drug is in Phase 1, with data expected in the second half of this year, and the company has a pipeline of early-stage treatments targeting extrachromosomal DNA.

Policy

Banning WuXi is more complicated than it might sound

A bill moving through Congress is meant to effectively ban certain Chinese life sciences companies from doing business in the U.S., thereby preserving the competitive advantage of American drug manufacturers. But actually going through with it risks seriously hobbling the companies it's purported to help.

Among the Chinese firms in Congress' crosshairs is WuXi AppTec, a contractor that gets more than half of its revenue from U.S. companies. As Bloomberg reports, that includes Eli Lilly, which relies on WuXi to manufacture the active ingredient in its GLP-1 treatments for diabetes and obesity. If contracting with WuXi became functionally illegal, Lilly and many of its peers would have to restructure their supply chains, risking drug shortages that could leave patients wanting.

But that hasn't interrupted the bill's progress. The Biosecure Act passed a Senate panel yesterday, STAT's John Wilkerson reports, and a similar measure is under consideration in the House.

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