Invivyd Earns Fast Track Designation for VYD2311, a Vaccine-Alternative Antibody to Prevent COVID [Yahoo! Finance]
Invivyd, Inc. (IVVD)
Company Research
Source: Yahoo! Finance
Food and Drug Administration (FDA) has granted Fast Track designation for VYD2311, an investigational vaccine-alternative monoclonal antibody candidate for the prevention of COVID. Fast Track is a process that enables the FDA to expedite the development and review of new drugs that address a serious or life-threatening condition and fill an unmet medical need. If relevant criteria are met, programs with Fast Track designation can become eligible for priority review and rolling Biologics License Application (BLA) submission, which can reduce the timelines associated with regulatory action. VYD2311 was granted Fast Track designation by the FDA for the prevention of COVID in individuals with underlying risk factors for severe COVID. “COVID is a critical ongoing endemic and chronic health challenge, and Americans need more options to prevent themselves from getting sick,” said Marc Elia, Chairman of Invivyd's Board of Directors. “We are thrilled that the FDA recognizes the need to mov
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News
- Invivyd Announces Initiation of DECLARATION Clinical Trial, a Phase 3 Placebo-Controlled Pivotal Study of VYD2311, a Vaccine-Alternative Antibody to Prevent COVID [Yahoo! Finance]Yahoo! Finance
- Invivyd Earns Fast Track Designation for VYD2311, a Vaccine-Alternative Antibody to Prevent COVIDGlobeNewswire
- Invivyd Announces Initiation of DECLARATION Clinical Trial, a Phase 3 Placebo-Controlled Pivotal Study of VYD2311, a Vaccine-Alternative Antibody to Prevent COVIDGlobeNewswire
- Invivyd (IVVD): Assessing Valuation After S&P Biotechnology Select Industry Index Inclusion [Yahoo! Finance]Yahoo! Finance
- Invivyd (NASDAQ:IVVD) is now covered by analysts at BTIG Research. They set a "buy" rating on the stock.MarketBeat
IVVD
Earnings
- 11/6/25 - Miss
IVVD
Sec Filings
- 12/23/25 - Form 8-K
- 12/19/25 - Form S-3/A
- 11/25/25 - Form SCHEDULE
- IVVD's page on the SEC website