Adaptimmune Announces U.S. FDA Acceptance of Biologics License Application for Afami-cel for the Treatment of Advanced Synovial Sarcoma with Priority Review [Yahoo! Finance]
Adaptimmune Therapeutics plc - American Depositary Shares (ADAP)
Last adaptimmune therapeutics plc - american depositary shares earnings: 5/9 07:30 am
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ir.adaptimmune.com/phoenix.zhtml?c=253991&p=irol-newsarticle&id=2255800
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Source: Yahoo! Finance
Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - January 31, 2024) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its Biologics License Application (BLA) for afami-cel, an investigational engineered T-cell therapy for advanced synovial sarcoma. The application has a Prescription Drug User Fee Act (PDUFA) target action date of August 4, 2024. Adrian Rawcliffe, Adaptimmune's Chief Executive Officer: “The FDA's acceptance of the BLA submission brings us one step closer to redefining treatment for people with synovial sarcoma. Our franchise has great potential and, if approved, we have the capabilities and the capital to launch afami-cel - the first engineered T-cell therapy on the market for a solid tumor cancer.” Dennis Williams, PharmD, Senior VP of Late-Stage Development: "Historic ou
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ADAP
Sec Filings
- 4/22/24 - Form ARS
- 4/12/24 - Form 8-K
- 4/11/24 - Form DEF
- ADAP's page on the SEC website