Enanta Pharmaceuticals Inc. hit the mark that Wall Street hoped for, and details rolled out in top-line results from the first-in-pediatrics phase II study evaluating once-daily, oral zelicapavir in hospitalized and non-hospitalized children aged 28 days to 36 months with respiratory syncytial virus (RSV).
Wall Street promptly began trying to weigh the compound’s marketplace odds after Merck & Co. Inc. detailed positive data from the phase IIb/III trial known as MK-1654-004 with clesrovimab, an investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season. The results, plus interim findings from the ongoing phase III experiment dubbed MK-1654-007 were offered during IDWeek 2024 in Los Angeles.
Suzhou Longbotai Pharmaceutical Co. Ltd. has disclosed benzimidazole derivatives reported to be useful for the treatment of respiratory syncytial virus (RSV) infections.
Immorna Biotherapeutics Inc. has received a grant from the Bill & Melinda Gates Foundation to support the clinical development of JCXH-108, a monovalent respiratory syncytial virus (RSV) vaccine based on Immorna’s proprietary mRNA and ready-to-use (RTU)-lipid nanoparticle (LNP) technologies.
Many respiratory syncytial virus (RSV) disease vaccines are for older adults but Merck & Co. Inc.’s monoclonal antibody, MK-1654 (clesrovimab), which just produced positive top-line phase IIb/III data, aims at a far smaller and younger market. Data for protecting healthy preterm and full-term infants from RSV disease show the double-blind, randomized, placebo-controlled clinical trial hit all its primary efficacy and safety endpoints, including the incidence of RSV-associated medically attended lower respiratory infection for 150 days compared to placebo.
CSPC Pharmaceutical Group Ltd. has received clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China with SYS-6016, the company’s mRNA respiratory syncytial virus (RSV) vaccine.
Moderna Inc. gained U.S. FDA approval on May 31, nearly three weeks past its original PDUFA date, for its respiratory syncytial virus (RSV) vaccine Mresvia (mRNA-1345), which had both breakthrough therapy and fast track designations in the U.S.