Bitcoin price today: gains to $120k, near record high on U.S. regulatory cheer
Investing.com -- GSK (NYSE:GSK) (LON:GSK) said on Monday that the U.S. Food and Drug Administration has accepted its priority review application for gepotidacin, an oral antibiotic aimed at treating sexually transmitted uncomplicated gonorrhoea.
The drugmaker’s shares climbed 1% in London on the news.
The company is looking to new infectious disease products, including its recently launched respiratory syncytial virus vaccine, to offset expected revenue declines from top-selling medicines and looming patent expirations in its HIV portfolio.
Gepotidacin is already approved in the U.S. under the brand name Blujepa for treating a common urinary tract infection in women and adolescent girls.
The FDA is expected to decide in December on its use for uncomplicated urogenital gonorrhoea, which could offer patients an oral alternative to existing injectable treatments.
Separately, GSK and Germany’s CureVac last week resolved a long-running patent dispute with Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) over mRNA vaccine technology used during the COVID-19 pandemic.
The settlement follows BioNTech’s June agreement to acquire CureVac in an all-stock deal worth $1.25 billion to advance work on mRNA-based cancer therapies.
Under the settlement, CureVac and GSK will receive $740 million and single-digit percentage royalties on future U.S. sales of COVID-19 vaccines, CureVac said. GSK’s share amounts to $370 million, including $50 million to adjust terms from a 2024 licence agreement that expanded their pandemic-era partnership.
If BioNTech’s takeover of CureVac is completed, related mRNA litigation outside the U.S. will also be resolved, with GSK receiving an additional $130 million and royalties extended to non-U.S. sales. CureVac said the acquisition remains on track under the agreed terms.
GSK said it still has separate patent cases against Pfizer and BioNTech in the U.S. and Europe, which are unaffected by this settlement.