Capricor Therapeutics Inc. said it has received a complete response letter from the U.S. FDA on the BLA for deramiocel to treat cardiomyopathy in Duchenne muscular dystrophy patients. The BLA has a priority review and had an Aug. 31 PDUFA date. According to Capricor, the agency said the BLA does not meet the statutory requirement for substantial evidence of effectiveness, that more clinical data were needed, and that there were outstanding CMC items. Deramiocel is composed of allogeneic cardiosphere-derived cells. The company’s stock (NASDAQ:CAPR) was taking a solid hit at midday, with shares going for $7.77, a 32% drop on the day so far.

Chugai and Gero partner to tackle age-related diseases

Roche AG subsidiary Chugai Pharmaceutical Co. Ltd. and Singapore’s Gero Pte. Ltd. plan to tackle age-related diseases by collaborating to identify drug targets through Gero’s AI-driven human data-first platform. If successful, Tokyo-based Chugai will use the new drug targets to create novel antibody drug candidates using its antibody engineering technologies. Chugai gains exclusive worldwide rights to the antibodies for the identified targets, and will pay up to $250 million in up-front payments, plus royalties on sales if products are launched. Although some have estimated the deal to be worth about $1 billion, Gero co-founder and CEO Peter Fedichev told BioWorld that “there is no upper limit with all the probabilities.”

NIH capping science journal fees for open access published research

The National Institutes of Health has opened another front in its cost cutting drive, saying it will cap the fees science journals charge for publishing papers authored by researchers it funds. A “growing prevalence of unreasonably high article processing charges” has “placed undue financial pressure on researchers and funders,” said NIH director Jay Bhattacharya, announcing the plan. In response, NIH is to “crack down on excessive publisher fees for publicly funded research” as part of an ongoing commitment to “scientific transparency and responsible stewardship of taxpayer dollars,” he said. NIH’s swipe at article processing charges comes at a time when tensions are mounting in the world of science publishing, with questions about the independence of peer review, research integrity and the reproducibility of research.

Biopharma deals hit $35B in June, highest month of 2025 so far

Biopharma dealmaking in June 2025 reached $35.07 billion, the highest monthly total of the year so far and one of the strongest single-month performances in recent years. The first-half 2025 deal value reached $138.31 billion, outpacing the first half of 2024 and exceeding full-year totals from several pre-2020 years. Biopharma deal volume reached 102 transactions in June, the highest monthly total since January but below the levels seen in stronger years.

Circode applies circRNA to heart disease drug R&D, in vivo CAR T

Shanghai Circode Biomed Co. Ltd. is set to begin clinical trials of HM-2002, a circular RNA (circRNA)-based drug for ischemic heart disease (IHD), having gained IND clearance in China Jan. 10 and the U.S. on May 30, Circode CEO Chenxiang Tang recently told BioWorld. The injectable vascular endothelial growth factor-targeting candidate is the first circRNA-based drug to be used in patients worldwide, with three IHD patients undergoing coronary artery bypass graft surgery dosed in an investigator-initiated trial at Shanghai Ruijin Hospital since September 2024. HM-2002 is one of six assets in the Shanghai-based company’s three-pronged portfolio, alongside two in vivo CAR T-cell therapy candidates and two influenza vaccine candidates.

At Glia 2025, searching for memories in the matrix

At first blush, the brain’s extracellular matrix (ECM) seems like the opposite of synaptic plasticity. Plasticity is the ability to change; the ECM is stable, to the point that it is often described as a scaffold – something to lend stability. “ECM proteins have some of the longest lifetimes of any protein in the brain,” Anna Molofsky told her audience at the XVII Meeting on Glial Cells in Health and Disease, which is being held in Marseille this week. Molofsky is an associate professor of neuroscience and psychiatry at the University of California at San Francisco. In her plenary talk, she took her audience through a tour de force of the ways in which plasticity depends on stability – and how the ECM is shaped by microglia to enable plasticity. Ultimately, the systems she described are critical to information processing and storage, arguably the brain’s most important job. When plasticity goes awry, it also plays a role in many neurological disorders.

Also in the news

Alvotech, Arcus, Ascentage, Astellas, Astrazeneca, Beigene, Beone, Biocytogen, Brenig, Calidi, Eolas, Hemostemix, Inventiva, Jazz, Klotho, Merck, Mereo, Moderna, Nasus, Osivax, PDS, Pfizer, Renasant, Rhythm, Secarna, Soleno, Taiho, Tonix, Transcend, Transgene, Ultragenyx, Vect-Horus, Xaira