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).
As mpox has now been found in the EU, the race for an effective vaccine has accelerated, with a study failure but increased vaccine production from Europe. The U.S. NIH just released top-line results from a preliminary analysis of a placebo-controlled study of Siga Technologies Inc.’s antiviral, tecovirimat, showing it missed the primary endpoint of statistically significant improvement within 28 days post-randomization in time to lesion resolution for patients in the Democratic Republic of the Congo.
Osaka, Japan-based Shionogi & Co. Ltd. said May 13 that ensitrelvir fumaric acid (Xocova), its oral antiviral for COVID-19, showed no statistical difference against placebo in completely resolving 15 common COVID-19-related symptoms in a global phase III Scorpio-HR trial.
What CEO Jason Okazaki called Assembly Biosciences Inc.’s “monumental” deal for new antivirals with Gilead Sciences Inc. brings $100 million right away, consisting of an $84.8 million up-front payment and a $15.2 million equity investment. Wall Street liked it, and shares of South San Francisco-based Assembly (NASDAQ:ASMB) closed Oct. 17 at $1.25, up 52 cents or 72%, on word of the 12-year arrangement. Gilead (NASDAQ:GILD) ended at $80.48, up $1.28.
Researchers from NYU Grossman School of Medicine reported on a new strategy intended to provide long-term protection against the SARS-CoV-2 virus using an experimental decoy.
Pfizer Inc.’s Paxlovid (nirmatrelvir/ritonavir) became the first oral antiviral to win full U.S. FDA approval for treating COVID-19, cleared for use in adults who are at high risk for progression to severe disease, including hospitalization or death. The nod follows two months after the agency’s Antimicrobial Drugs Advisory Committee voted 16-1 in favor of Paxlovid’s overall benefit-risk assessment.