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Recent press releases and 8-K filings for SGIOY.

Shionogi Presents Positive Cefiderocol Data at IDWeek 2025
SGIOY
Product Launch
New Projects/Investments
  • Shionogi presented new data at IDWeek 2025, highlighting the broad activity of its antibiotic cefiderocol (Fetroja®/Fetcroja®) across various infection types and adult patient populations.
  • The PROVE study demonstrated an overall clinical cure rate of 70.1% in the U.S. cohort for serious Gram-negative bacterial infections, with earlier cefiderocol use showing a higher cure rate of 73.7%.
  • Cefiderocol proved effective against bacteria non-susceptible to beta-lactam–beta-lactamase inhibitor combinations, achieving a clinical cure rate of 70.2% for such infections in real-world settings.
  • Data from the SENTRY Antimicrobial Surveillance Program confirmed cefiderocol's activity against a broad range of clinically relevant Gram-negative pathogens, maintaining high susceptibility over a five-year period from 2020 to 2024.
Oct 20, 2025, 12:30 PM
Shionogi's Ensitrelvir NDA Accepted by FDA for COVID-19 Prevention
SGIOY
Product Launch
New Projects/Investments
  • The FDA has accepted Shionogi's New Drug Application (NDA) for ensitrelvir (S-217622), an investigational oral antiviral for the prevention of COVID-19 following exposure to an infected individual, which, if approved, would be the first and only oral therapy for this indication.
  • The NDA is supported by results from the global Phase 3 Study, SCORPIO-PEP, and the FDA has set a Prescription Drug User Fee Act (PDUFA) action date of June 16, 2026.
  • Ensitrelvir, known as Xocova® in countries where it is approved, received emergency regulatory approval in Japan in November 2022 and full approval in March 2024 for the treatment of COVID-19.
Sep 2, 2025, 12:30 PM
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