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Today, a brief rundown of news involving Teva Pharmaceutical and BioMarin Pharmaceutical, as well as updates from GSK, the Food and Drug Administration and BioNTech that you may have missed.Teva Pharmaceutical said an experimental antibody drug its developing succeeded in a mid-stage trial in celiac disease. When compared to a placebo over the course of eight weeks, Tevas drug,TEV 408, demonstrated a statistically significant and clinically meaningful ability to prevent gluten-induced intestinal damage, according to Teva. Coupled with data from an early-stage trialin the inflammatory skin condition vitiligo, the results suggest TEV 408 has pipeline-in-a-product potential, Teva said. Analyses from an ongoing Phase 2a study are underway. Teva will present additional results at a future scientific meeting. Delilah AlvaradoBioMarin Pharmaceutical has settled a patent dispute with rival Ascendis Pharma over a drug Ascendis recently brought to market for achondroplasia, the most common form of dwarfism. BioMarin had alleged that Ascendis infringed on a patent in developing that treatment, known as Yuviwel and approved by U.S. regulators in March. The settlement announced Monday hands BioMarin a 20% royalty on net U.S. sales of Yuviwel and an 18% royalty on net sales in Europe, Brazil and South Korea until 2030. While investors expected a deal, the economic terms for BioMarin are better than anticipated, and a hedge against patients switching off the companys drug Voxzogo, wrote Stifel analyst Paul Matteis. Ben FidlerA federal judge has delayed a closely watched lawsuittwo attorneys general in Texas and Florida filed against the Food and Drug Administration over the abortion pill mifepristone.The FDA approved mifepristone in 2000 and testing, as well as years of use,have proventhe drugsafe and effectivefor terminating pregnancy. But the states have argued that the agency didnt adequately evaluate mifepristone, and aim to convince the courts to curb access. Mondays ruling, from a judge in Texas, granted a Department of Justice request to pause the suit until either Dec. 1 or when the FDA finishes an ongoing safety review of the drug, whichever comes first. Delilah Alvarado GSK said Tuesdayit will move an experimental mRNA vaccine for seasonal influenza into late-stage testing following positive results in a Phase 2 study. According to GSK, the shot spurred stronger immune responses, against all strains, than standard- and high-dose flu vaccines in that mid-stage trial. The upcoming study beginning in September will be the first Phase 3 trial of an mRNA vaccine targeting two key surface antigens hemagglutinin and neuraminidase that help the flu virus spread. GSK acquired that vaccine in a deal with CureVactwo years ago. Delilah AlvaradoBioNTech on Friday announced plans to terminate a Phase 2 study testing an experimental mRNA vaccine called autogene cevumeranagainst colorectal cancer. BioNTech previously said that the trial was likely to fail, but still continued the study as trial investigators concluded there hadnt been enough follow-up time to properly evaluate the treatments efficacy. Since then, though, those trial monitors detected a numerical imbalance in survival between the treatment and placebo groups and recommended ending the trial. BioNTech and Roche are co-developing the vaccine under a longstanding alliance. Ben Fidler '

In a deal that will end intellectual property claims in five countries, including one before the International Trade Commission, Ascendis has agreed to pay a sizeable royalty to California-based BioMarin. The deal centers on Yuviwel, Acendis’ once-weekly injection for children with achondroplasia, a leading cause of dwarfism. A C-type natriuretic peptide (CNP) analog prodrug using transient conjugation drug delivery, Yuviwel received FDA accelerated approval in February and is in direct competition with BioMarin’s Voxzogo, a daily injection for achondroplasia approved in 2021. BioMarin alleged that Yuviwel violates its patent on CNP variants, thereby launching intellectual property disputes in the U.S., Brazil, Germany, South Korea and Denmark. Today the two pharmas sidestepped significant legal overhang by settling the dispute with a licensing deal that analysts are calling mutually beneficial. Per the terms, BioMarin now collects royalties on the more convenient competitor product. Ascendis will pay 20% of Yuviwel net sales in the U.S. dating back to the first commercial sales through to May 2030. Pending approval, Ascendis will also pay 18% of net sales in the European Union, Brazil and South Korea through May 2030. For BioMarin, consensus estimates cited by Jefferies have projected the royalty stream to be worth $280 million in U.S. revenue and $440 million in non-U.S. revenue by 2030. “This outcome incentivizes companies like BioMarin to keep investing in the kind of long-term innovation that is critical to bringing breakthrough treatments to the people who need them,” BioMarin CEO Alexander Hardy said in an Aug. 31 statement. In exchange, BioMarin will dismiss pending lawsuits and grant Ascendis a wide license to Yuviwel-related patents for both current and potential indications, allowing Ascendis to continue developing the CNP franchise without restriction. “The agreement allows BioMarin to participate economically in Yuviwel's commercial success, with royalties that should partly offset future Voxzogo sales erosion as patients switch to Ascendis' weekly therapy,” William Blair analysts said in a report. Ascendis reported 8 million euros ($9.3 million) in second-quarter revenue for Yuviwel after the drug’s April launch. In July, BioMarin said 90% of its U.S. patient base was still on Voxzogo, but that share is expected to shift to Yuviwel over time, William Blair noted. Meanwhile, Citi analysts called the agreement “net favorable” for the Yuviwel franchise. The royalties will cost Ascendis, but the deal removes the shroud of legal disputes and, perhaps more importantly, clears the way for future development in other skeletal dysplasia indications and in combination therapies currently under investigation at Ascendis, the Citi team argued. The settlement also specifically covers hypochondroplasia, a milder genetic bone disorder that causes shortened stature. BioMarin announced positive phase 3 results for Voxzogo in the indication in May 2026, and plans to file for supplemental approval by the end of the year. Ascendis has plans to start a similar phase 3 in hypochondroplasia, and any future approval would carry the same royalties through the 2030 window. “Importantly, the settlement has no bearing on the forward development of the TransCon CNP + hGH combo regimen (anticipated launch in 2030), which we continue to believe has best-in-class potential in [achondroplasia / hypochondroplasia],” Citi analysts wrote. In a late-summer readout of Ascendis’ phase 2 Coach trial, the combination therapy demonstrated durable and unprecedented growth in children with achondroplasia, matching the annualized growth velocity of the 97th percentile among children of average stature. The trial will complete around year-end 2026.