GSK (NYSE:GSK) announced Monday that the U.S. Food and Drug Administration has accepted its priority review application for gepotidacin, an oral antibiotic designed to treat uncomplicated sexually transmitted gonorrhea.
Following the news, GSK’s shares edged up 1% in London trading.
The pharmaceutical company is focusing on new infectious disease treatments, including its recently introduced respiratory syncytial virus vaccine, to help offset anticipated revenue declines from key drugs facing patent expirations in its HIV lineup.
Gepotidacin is already approved in the U.S. under the brand name Blujepa for treating common urinary tract infections in women and adolescent girls.
The FDA’s decision on its use for uncomplicated urogenital gonorrhea is expected in December, potentially providing patients with an oral alternative to current injectable therapies.
Separately, GSK and German biotech CureVac resolved a long-standing patent dispute last week with Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) related to mRNA vaccine technology used during the COVID-19 pandemic.
This settlement follows BioNTech’s June announcement to acquire CureVac in a $1.25 billion all-stock deal aimed at advancing mRNA-based cancer treatment research.
As part of the agreement, CureVac and GSK will receive $740 million plus single-digit royalties on future U.S. sales of COVID-19 vaccines, with GSK’s portion totaling $370 million—including $50 million to revise terms from a 2024 licensing deal that expanded their pandemic partnership.
If the CureVac acquisition by BioNTech is completed, related mRNA patent litigation outside the U.S. will also be settled, with GSK set to receive an additional $130 million and royalties extended to non-U.S. vaccine sales. CureVac confirmed the acquisition remains on track under the agreed conditions.
GSK noted that other patent cases against Pfizer and BioNTech in the U.S. and Europe remain ongoing and are not impacted by this settlement.
This content is for informational purposes only and does not constitute financial, investment, or other professional advice. It should not be considered a recommendation to buy or sell any securities or financial instruments. All investments involve risk, including the potential loss of principal. Past performance is not indicative of future results. You should conduct your own research and consult with a qualified financial advisor before making any investment decisions.