Valneva and LimmaTech Awarded FDA Fast Track Designation for Tetravalent Shigella Vaccine Candidate S4V
Valneva SE - American Depositary Shares (VALN)
Company Research
Source: GlobeNewswire
Saint Herblain (France) and Schlieren (Zurich), October 16, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Shigella4V (S4V), the world’s most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate, for which Valneva obtained an exclusive worldwide license from LimmaTech. Fast Track designation is granted by the FDA to products under development that have the potential to treat serious conditions and fill an unmet medical need. It is designed to facilitate the clinical development and expedite the review of important new products with the intention to get them to the people who need them earlier1. Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “Shigellosis is the second leading ca
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News
- Valneva and LimmaTech Announce First Vaccination in Phase 2b Human Challenge Study of Tetravalent Shigella Vaccine Candidate S4V2 [Yahoo! Finance]Yahoo! Finance
- Valneva and LimmaTech Announce First Vaccination in Phase 2b Human Challenge Study of Tetravalent Shigella Vaccine Candidate S4V2GlobeNewswire
- Valneva to Present and Hold Investor Meetings at Upcoming U.S. and European Healthcare ConferencesGlobeNewswire
- Valneva SE (INRLF) Q3 2024 Earnings Call Highlights: Strong Revenue Growth and Improved ... [Yahoo! Finance]Yahoo! Finance
- Valneva Reports Nine-Month 2024 Financial Results and Provides Corporate UpdatesGlobeNewswire
VALN
Analyst Actions
- 9/3/24 - HC Wainwright
VALN
Sec Filings
- 11/13/24 - Form 6-K
- 11/7/24 - Form 6-K
- 10/21/24 - Form 6-K
- VALN's page on the SEC website