GSK (GSK) announced that the US Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, for GSK5764227, GSK’227, its B7-H3-targeted antibody-drug conjugate being evaluated for the treatment of adult patients with relapsed or refractory osteosarcoma who have progressed on at least two prior lines of therapy. This is the third regulatory designation for GSK’227, following the European Medicines Agency’s decision to grant Priority Medicines, PRIME, designation and the FDA’s decision to grant Breakthrough Therapy Designation for relapsed or refractory extensive-stage small-cell lung cancer in August 2024 and December 2024, respectively.
Stay Ahead of the Market:
- Discover outperforming stocks and invest smarter with Top Smart Score Stocks
- Filter, analyze, and streamline your search for investment opportunities using Tipranks' Stock Screener
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
See Insiders’ Hot Stocks on TipRanks >>
Read More on GSK:
- GSK’s Nucala Gains Approval in China for CRSwNP
- GSK’s Nucala approved in China as add-on therapy for adults with CRSwNP
- GSK Updates Shareholders on Voting Rights and Capital Structure
- IDEAYA Biosciences (IDYA): A Down Year Presents a Window of Opportunity for Investors
- FDA revokes EUAs for some antibody treatments for COVID-19
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
