After a tough few weeks for Sarepta Therapeutics Inc., the EMA dealt another blow on July 25, announcing it will not be approving the Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec). The rejection is on the grounds that the main placebo-controlled study, in children aged 4-7 years who were still able to walk, had failed to show Elevidys had an effect on movement abilities after 12 months. Re-examination of the file led to a happier outcome for another drug that has attracted considerable controversy, Eli Lilly and Co. Inc.’s Kisunla (donanemab) for treating the early stages of Alzheimer’s disease. The monoclonal antibody was rejected by the EMA in March 2025 on the grounds that the benefits in slowing disease progression did not outweigh the risks of edema and hemorrhage in the brain. In its change of mind, the CHMP makes no mention of its previous view, and says Kisunla should be approved for people who are ApoE4 heterozygotes, or non-carriers of the gene.

Memo's potravitug reduces BK viral load in kidney transplant

Memo Therapeutics AG is laying plans to advance its BK polyomavirus neutralizing monoclonal antibody potravitug into phase III development after reporting positive phase II results in treating infections in immunocompromised kidney transplant patients. The primary endpoint of undetectable BK polyomavirus in blood was not reached, but the treated group had a significantly higher reduction in viral load and resolution of nephropathy sparked by the virus at week 20. Memo says the improvement, which was confirmed by comparing kidney biopsies at day 141 with those taken at baseline, indicates there was a resolution of the underlying disease, while there was no change in the placebo group.

Brandon Capital closes sixth life sciences fund at AU$439M

Brandon Capital Partners Pty Ltd., Australia’s largest life sciences venture capital firm, announced the final close of its sixth fund at AU$439 million (US$288 million), the VC’s largest fund to date. As previously reported by BioWorld, the first close of Brandon Capital’s sixth fund was in June 2024 with AU$270 million. Brandon Capital co-founder and Managing Partner Chris Nave told BioWorld that traditional venture capital funds run for about 10 years, but Brandon has expanded its funding to 15 years. “Often technologies are early in Australia, so it takes a lot longer to get them to the stage of generating a return, and so our funds have been 15-year funds … to give us more time to build the assets,” Nave said.

Device, drug makers weigh in on Janssen’s FCA case

Janssen Pharmaceutical’s loss in a False Claims Act (FCA) case for the company’s HIV treatments resulted in judgments of roughly $1.6 billion, which the company appealed to the Court of Appeals for the Third Circuit. The case drew the attention of multiple parties including two life science trade associations, which contend not only are the damages inappropriate, but also the qui tam provisions of the False Claims Act are on shaky legal grounds.

Two cancer drugs combined modify Alzheimer’s disease in mice

Current treatments for Alzheimer’s disease have limited effects. While they can slow cognitive decline or alleviate symptoms, they do not reverse this complex neurodegenerative condition caused by multiple factors. Researchers from the Gladstone Institutes and the University of California, San Francisco have screened FDA-approved drugs in search of agents that could potentially modify the disease. They identified two cancer therapies which, when combined, have a protective effect on neurons and glial cells, reversing some of the disease’s most damaging symptoms, such as the loss of nerve cells and memory.

Biopharmas busy with numerous clinical successes last month

In June 2025, BioWorld tracked 254 clinical trial updates across phases I to III, up from 223 in May, 151 in April and 197 in March. Of the June updates, 24 trials reported positive phase III results, while only one was reported as a failure. Compass Pathways plc reported positive top-line results from its phase III Comp005 trial evaluating COMP-360, a synthetic psilocybin therapy, for treatment-resistant depression. The study showed a statistically significant and clinically meaningful reduction in depression severity at six weeks compared to placebo. The company called it the first phase III efficacy data for a classic psychedelic.

Also in the news

3Sbio, Abivax, Aldeyra, Alzecure, Astra, Atara, Bavarian Nordic, Biomea Fusion, Candel, Citryll, Galapagos, Gate Bioscience, Genentech, GSK, Eli Lilly, Kling, Leo, Matchpoint, Novartis, Palisade, Pfizer, Roche, Rocket, Sanofi, Sprout, TCG Labs Soleil, Tharimmune, Windtree, Verastem, Verve