Today, a brief rundown of news involving Eisai, Sarepta Therapeutics and Sandoz, as well as updates from Mural Oncology, Cyprumed and Spruce Bio that you may have missed.
After a long regulatory saga, Eisai and Biogen have secured European market authorization for their Alzheimer’s drug Leqembi. Regulators at the European Medicines Agency initially rejected Leqembi last summer, only to reverse course after the companies appealed. But the European Commission, which finalizes product clearances, asked the EMA to review new safety data, delaying Leqembi’s evaluation further. The EC later referred Leqembi to an appeals committee before making Tuesday’s decision. Under the authorization, Leqembi is available for use in adults with mild dementia or cognitive impairment due to Alzheimer’s, and who have only one or no copies of a certain gene called APOE4. People with two copies of APOE4 are thought to be more likely to experience a side effect known as ARIA following Leqembi treatment. — Ned Pagliarulo
The Food and Drug Administration has cleared Sarepta Therapeutics to begin dosing U.S. patients in a study testing a gene therapy it’s developing for a form of limb-girdle muscular dystrophy. Sarepta has several such programs in testing for different types of limb-girdle, led by a treatment for the 2E/R4 form that could produce Phase 3 results in the first half of this year. The latest program, SRP-9005, is for type 2C/R5, a severe form of limb-girdle that strikes in early childhood. — Ben Fidler
Generic drug manufacturer Sandoz has once again sued Amgen over intellectual property protecting Amgen’s blockbuster drug Enbrel from biosimilar competition. The federal lawsuit, filed in the Eastern District of Virginia, is on antitrust grounds, alleging Amgen engaged in anticompetitive practices when in 2004 it exclusively licensed a set of patents that originated with Roche. These patents currently bar biosimilar entry until 2029. The Food and Drug Administration granted approval to a Sandoz biosimilar called Erelzi in 2016, but it can’t yet launch in the U.S. Sandoz is asking the court to award it lost profits from 2021 until the suit’s filing, which can be tripled under antitrust law, and block Amgen’s exclusive use of the patents. Sandoz’ former owner, Novartis, sought to have Amgen’s Enbrel patents invalidated, but lost in federal court. — Jonathan Gardner
Mural Oncology is exploring strategic alternatives after its experimental cancer treatment nemvaleukin alfa failed a second clinical study, the company said Tuesday. Data showed the drug did not reach its primary endpoint in a melanoma trial, less than one month after Mural halted another study in platinum-resistant ovarian cancer. As part of its plan, Mural will cut its staff by 90%. The biotech originally began as a spinout of Irish drugmaker Alkermes in 2023, focusing on immuno-oncology. — Gwendolyn Wu
Merck & Co. has signed a non-exclusive license with Austrian drug delivery company Cyprumed for use of its oral peptide formulation technology. Under the terms of the deal, Cyprumed could receive up to $493 million in upfront payments and fees due on achievement of specific developmental and commercial goals. Merck will pay additional fees if it exercises its option for an exclusive license, and will be responsible for the research, development, manufacturing and commercialization of any drug that emerges from the collaboration. Cyprumed didn’t disclose what areas of medicine the two companies will collaborate in. — Jonathan Gardner
California-based Spruce Biosciences is changing course, announcing Tuesday it will to pursue development of a new enzyme replacement treatment for Sanfilippo syndrome, an inherited neurodegenerative disease. The biotech acquired a drug candidate called tralesinidase alfa, which was originally developed by BioMarin Pharmaceutical and then Allievex, before the latter ceased operations. Spruce plans to submit an application for accelerated approval to the FDA in 2026. The company’s new strategy comes four months after it discontinued development of its only drug, for a form of hyperplasia.— Gwendolyn Wu
