November 5, 2025

The need-to-know this morning

Biohaven Pharmaceuticals said its drug for spinocerebellar ataxia (SCA), a rare and debilitating neurodegenerative disease, was rejected by the FDA. The protracted review of the drug, called troriluzole, was controversial because Biohaven relied on historical data to demonstrate proof of efficacy. The FDA, in its letter to Biohaven, cited biases and confounding factors in those historical data as reasons for not approving the drug.
After 12 years leading Utah-based "techbio" company Recursion, CEO Chris Gibson is stepping down. Recursion's R&D head and Chief Commercial Officer Najat Khan will become CEO effective Jan. 1.
Amgen reported third-quarter earnings last night.

pharma

Novo CEO defends takeover bid for Metsera

As Novo Nordisk fights a bidding war against Pfizer to acquire the obesity biotech Metsera, its new CEO dismissed claims that its offer would run into regulatory issues and said that Metsera would complement its pipeline.

"If we did not feel that we would be able to close the deal, we would not have probably entered the transaction," Mike Doustdar, who took over as CEO in August, told reporters on a call tied to the company's third quarter earnings report.

Novo has been lagging behind Eli Lilly in the obesity market it created. This morning, the Danish company lowered the top range of its sales growth forecast for the year from 14% to 11%, due to lowered growth expectations for its GLP-1 drugs.

exclusive

Arena BioWorks abruptly shuts down

Arena BioWorks, the buzzy research institute that launched nearly two years ago with $500 million to support a decade of scientific R&D, is shutting down, the institute confirmed to STAT.

Arena will no longer conduct scientific research but its scientific discoveries to date will be handed over to its scientists for further development.

The founding investors opted to shut down the institute due to concerns about financing and the poor investment market, co-founder Stuart Schreiber said.

Read more from STAT's Allison DeAngelis and Jason Mast.

politics

Novo, Lilly near deal with Trump on GLP-1 drugs

The Trump administration is nearing a deal with Eli Lilly and Novo Nordisk to lower the prices of their GLP-1s and allow them to be covered by Medicare for weight loss, people familiar with the talks told STAT.

Currently, Medicare covers GLP-1s for indications such diabetes, cardiovascular risk prevention, and sleep apnea, but is legally barred from covering them for weight loss. If coverage is expanded, it could have major implications for public health.

But the true impacts of the possible deals remain unknown. Similar drug pricing agreements with other pharma companies were met with skepticism by policy experts.

biotech

Centessa reports early positive data of sleep drug

Centessa Pharmaceuticals this morning reported early data from a Phase 2 trial showing that its investigational drug for sleep disorders helped patients stay awake more.

The treatment, called ORX750, is part of a promising new class of sleep drugs called orexin receptor agonists. These medicines have been highly effective in patients with narcolepsy type 1, who have a deficiency of the orexin neuropeptide, but companies also see potential for testing them in narcolepsy type 2 and idiopathic hypersomnia, more common conditions in which patients don't have a significant orexin deficiency.

Centessa's trial enrolled patients with all three sleep disorders, and after two weeks of treatment, patients experienced statistically significant increases in the amount of time they could stay awake on a test compared with those on placebo.

The Phase 2 study is ongoing — there's another part of the trial that will look at efficacy after four weeks.

The biotech is competing against Alkermes and Takeda, which both have orexin candidates that are further along in development.

pharma

Pfizer's view on the Metsera bidding war

From STAT's Matthew Herper: Pfizer beat earnings expectations yesterday, but the biggest topic for investors was the company's bidding war with Novo Nordisk over the purchase of the obesity focused biotech Metsera. STAT had a chance to talk to Pfizer's chief financial officer, David Denton, about the deal.

Asked why Pfizer was seeking to acquire Metsera, Denton said: "It is not one asset, it is multiple assets in a platform.... We've obviously done a lot of work and understanding what's out in the marketplace and have clearly chosen that this asset we felt is superior for us."

Pfizer, he said, can develop the assets rapidly and market them in more places than any other firms.

The company has called Novo's offer "illusory," a "catch and kill" deal, and illegal because it involves a large payment being made to Metsera and paid to shareholders before the deal goes through regulatory review.

"If the first step of this occurs without any trade commission oversight, the harm's been done," said Denton.

financing

Another startup licenses from Jiangsu Hengrui

A new company, Braveheart Bio, has raised $185 million to develop a heart treatment from Chinese drugmaker Jiangsu Hengrui.

With funding from investors — including Andreessen Horowitz, Forbion, OrbiMed, Enavate Sciences, and Frazier Life Sciences — Braveheart will run a global late-stage trial of the treatment, a small molecule for hypertrophic cardiomyopathy.

Western VCs and pharmaceutical companies have repeatedly turned to Jiangsu Hengrui to license drugs. In July, GSK paid $500 million upfront for a single COPD drug from Hengrui.

Read more from STAT's Allison DeAngelis.

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