Ocugen, Inc. Announces Investigational New Drug Application in Effect After Review by FDA to Initiate Phase 1 Clinical Trial Evaluating First-in-Class OCU500 Inhaled Vaccine Candidate for ...
Ocugen, Inc. (OCGN)
Company Research
Source: GlobeNewswire
OCU500 will be administered via inhalation and as a nasal sprayCOVID-19 remains a substantial public health threat in the U.S. and around the worldPhase 1 clinical trial is anticipated to start in 2Q 2025 MALVERN, Pa., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the U.S. Food and Drug Administration (FDA) has reviewed the Company’s Investigational New Drug (IND) application and it is in effect. This is a critical step toward the initiation of the Phase 1 clinical trial for OCU500—an inhaled mucosal vaccine for COVID-19. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will sponsor and conduct the Phase 1 trial to assess the safety, tolerability, and immunogenicity of OCU500 administered via two different routes, inhalat
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OCGN
News
- Ocugen CEO to Present at Oppenheimer Movers in Rare Disease Summit [Yahoo! Finance]Yahoo! Finance
- Ocugen CEO to Present at Oppenheimer Movers in Rare Disease SummitGlobeNewswire
- How the Narrative Surrounding Ocugen Is Shifting After New Licensing and Analyst Developments [Yahoo! Finance]Yahoo! Finance
- Ocugen CEO to Present at NobleCon21—Noble Capital Markets' Twenty-First Annual Emerging Growth Equity Conference [Yahoo! Finance]Yahoo! Finance
- Ocugen CEO to Present at NobleCon21—Noble Capital Markets’ Twenty-First Annual Emerging Growth Equity ConferenceGlobeNewswire
OCGN
Earnings
- 8/1/25 - In-Line
OCGN
Sec Filings
- 12/18/25 - Form 8-K
- 12/8/25 - Form SCHEDULE
- 11/5/25 - Form 10-Q
- OCGN's page on the SEC website