Predictably, weekly vs. daily subcutaneous injections made a big difference in the achondroplasia space, where shares of Copenhagen, Denmark-based Ascendis Pharma A/S (NASDAQ:ASND) closed Sept. 16 at $139.57, up $20.35, or 17%, on favorable, pivotal top-line data with Transcon CNP (navepegritide), as competitor Biomarin Pharmaceutical Inc.’s stock (NASDAQ:BMRN) ended the day at $69.86, down $15.04, or 17.7%.
Genentech’s newly approved multiple sclerosis (MS) injection takes about 10 minutes to administer, dramatically reducing the four to six hours required by its intravenous predecessor. The U.S. FDA approved the humanized monoclonal antibody Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for relapsing MS and primary progressive MS on Sept. 13.
Eli Lilly and Co.’s Ebglyss (lebrikizumab) becomes the latest U.S. entrant in the increasingly competitive atopic dermatitis space, following FDA approval of the IL-13-targeting antibody, which will now go up against other biologics such as established blockbuster Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), as well as more recently approved Adbry (tralokinumab, Leo Pharma Inc.).
Biocom California’s most recent edition of its Let's Talk About series covered the future of women’s health. The panel of executives from companies and investors in women’s health were frustrated about the state of funding for the space. “Only about 1% of health care R&D dollars go [specifically] to women’s health outside of oncology,” Jenn Kiang, director of corporate affairs and development at Daré Bioscience Inc. told the audience. But the opportunity is huge, she said.
Immvira Group Co.’s oncolytic herpes simplex virus product, MVR-T3011, showed early efficacy via intravesical administration in patients with high-risk BCG-failure non-muscle invasive bladder cancer.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cidara, Emergent Biosolutions, Nona, Omrx Oncology, OS Therapies, Umoja.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Atea, Curevac, Hotspot Therapeutics, Immuneering, Moberg, Neurocrine, Vico, Zambon.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcturus, Bavarian Nordic, CSL Vifor, Halozyme, Nanoscope, Roche.