Opthea Announces Completion of Drug Substance PPQ Campaign Validating Manufacturing Process of Sozinibercept
Opthea Limited - American Depositary Shares (OPT)
Company Research
Source: GlobeNewswire
Three consecutive commercial-scale batches successfully produced Major milestone for potential BLA filing of sozinibercept in wet AMD Progress update of drug product PPQ campaign expected in early 2025 MELBOURNE, Australia and PRINCETON, N.J., Sept. 18, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ: OPT, “Opthea”, the “Company”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD), today announced the completion of its drug substance Process Performance Qualification (PPQ) campaign for sozinibercept. The PPQ campaign consisted of the production of three successful consecutive commercial-scale drug substance batches required for the validation of Opthea’s manufacturing process. The batches have been produced following an extensive manufacturing process development program. “The successful completion of the drug substance PPQ campaign
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News
- Opthea to Participate in November Investor ConferencesGlobeNewswire
- Opthea Files Notice of Annual General MeetingGlobeNewswire
- Opthea Wet AMD Program to be Presented at Innovate RetinaGlobeNewswire
- High Growth Tech Stocks in Australia to Watch [Yahoo! Finance]Yahoo! Finance
- Opthea appoints Tom Reilly as CFO [Seeking Alpha]Seeking Alpha
OPT
Sec Filings
- 11/4/24 - Form 6-K
- 11/1/24 - Form 6-K
- 10/28/24 - Form 6-K
- OPT's page on the SEC website