Editor’s Briefing: November 10, 2026

In Short. Bayer won U.S. approval for the first stroke-prevention pill that blocks the clotting protein factor XIa. Merck’s experimental drug for fatty-liver inflammation cleared the disease in most patients who took it in a mid-stage trial.

Bayer’s asundexian becomes the first approved factor XIa blocker

ABOUT ONE in ten people who survive a stroke has another within a year, according to Bayer, and repeat strokes are often more damaging than the first. On Monday the Food and Drug Administration approved Bayer’s asundexian, sold as Sunharbo, for adults after a mild-to-moderate stroke caused by a clot that did not come from the heart, or after a brief, high-risk interruption of blood flow to the brain known as a transient ischemic attack (FDA release). It is taken once a day alongside antiplatelet drugs that keep platelets from clumping, and it blocks factor XIa, a clotting protein. In the OCEANIC-STROKE trial, 6.2% of 6,162 patients on asundexian had an ischemic stroke, against 8.4% of 6,165 on placebo (Bayer release). Major bleeding was similar overall, at 1.6 and 1.5 events per 100 patient-years, but was more common with the drug in patients older than 75 and in the first 90 days. The drug is not approved for stroke prevention in patients with atrial fibrillation.

Merck’s efinopegdutide clears fatty-liver inflammation in a Phase 2b trial

In metabolic dysfunction-associated steatohepatitis, or MASH, fat builds up in the liver and causes inflammation and scarring that can progress to cirrhosis and liver failure. On Monday Merck presented 52-week results for efinopegdutide, a weekly injection that acts on two hormone receptors, GLP-1 and glucagon, at The Liver Meeting in Denver, with simultaneous publication in The Lancet (Merck release). The trial gave 381 adults with moderate or advanced scarring one of three doses, placebo or open-label semaglutide. Liver biopsies showed MASH resolved without worse scarring in 63% of 77 patients on the 7 mg dose and 13% of 79 on placebo. Scarring improved by at least one stage, without the inflammation getting worse, in 52% of the 7 mg group and 21% of the placebo group. Nausea affected 39% of the 7 mg group, and 11% of 79 patients on the 10 mg dose stopped treatment because of side effects. Merck licenses the drug from Hanmi Pharmaceutical.

The Pentagon removes WuXi AppTec from its Chinese military company list

WuXi AppTec is a Chinese company that does contract research, development and manufacturing for drug developers. Under Section 1260H of a 2021 defense law, the Department of Defense publishes a list of “Chinese military companies”, and in June it named WuXi AppTec, which sued and in August won a preliminary injunction against the designation. A notice in Tuesday’s Federal Register, filed on Monday, says the department’s deputy secretary decided to delist the company “in compliance with the order issued by the U.S. District Court of Columbia on August 7, 2026” (Federal Register notice). The removal is “without prejudice to relisting the company on additional or supplementary grounds.” In a Hong Kong exchange filing on Tuesday, WuXi AppTec said the decision “relieves the Company from further adverse consequences of the 1260H designation” (WuXi AppTec announcement).

An appeals court hears Acadia’s Nuplazid patent case

Nuplazid (pimavanserin) is Acadia’s drug for the hallucinations and delusions that can affect people with Parkinson’s disease, approved by the FDA in 2016. In May 2025 a federal court in Delaware ruled for Acadia on a patent covering the drug’s 34 mg capsule, and that ruling was appealed. Acadia said a three-judge panel of the U.S. Court of Appeals for the Federal Circuit heard oral arguments in the case and that it expects a decision in the first half of 2027 (Acadia release). If the Delaware ruling stands, Acadia expects the capsule patent to protect Nuplazid until February 2038. If it does not, Acadia expects protection to end in October 2030, based on an earlier patent on the molecule itself and an added period of exclusivity granted for testing in children. Acadia also expects a price negotiated under the Inflation Reduction Act to apply to Nuplazid from 2029.

Aldeyra withdraws an agreed trial design for an eye lymphoma drug

Primary vitreoretinal lymphoma is a rare cancer of immune cells that affects the retina and the gel inside the eye. Aldeyra is developing ADX-2191 for the disease and had agreed the design of a trial with the FDA’s ophthalmology division through a written review of the protocol, called a special protocol assessment. In a filing on Monday, Aldeyra said it has asked that division to recommend moving review of the drug to the agency’s Division of Hematologic Malignancies 2, because lymphoma reviews are typically conducted there (Aldeyra 8-K). In connection with the request, Aldeyra withdrew the trial protocol that the ophthalmology division had agreed to. The company does not expect to start that trial while the request is pending, and it said the regulatory path for ADX-2191 in this disease is now uncertain.