On Thursday, the U.S. Food and Drug Administration (FDA) approved GSK Plc’s (NYSE:GSK) supplemental New Drug Application for gepotidacin as an oral option for uncomplicated urogenital gonorrhoea.
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Gonorrhoea is a common, sexually transmitted infection caused by Neisseria gonorrhoeae.
GSK said, in 2023, there were over 600,000 cases of gonorrhoea reported in the United States according to the CDC, making it the second most commonly reported sexually transmitted infection in the country.
The approval covers adult and pediatric patients from 12 years of age weighing at least 45 kg who have limited or no alternative options for uncomplicated urogenital gonorrhoea caused by susceptible strains of Neisseria gonorrhoeae.
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The milestone follows the FDA approval of gepotidacin earlier this year as an oral treatment for female adults and pediatric patients 12 years of age and older with uncomplicated urinary tract infection (uUTI).
The U.S. application was based on results from the EAGLE-1 phase 3 trial, which demonstrated that gepotidacin was non-inferior to standard of care combination treatment for gonorrhoea (intramuscular ceftriaxone plus oral azithromycin).
The trial also supported the safety and tolerability profile of gepotidacin, with no serious drug-related adverse events observed in either the gepotidacin or the comparator arm. The most common reported adverse reactions were mild to moderate gastrointestinal events.
On Friday, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended expanding the indication of GSK’s adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to all adults aged 18 years and older.
The European Commission’s final decision is expected in February 2026.
If approved, the expanded indication would make the vaccine available for all adults aged 18 years and older.
Arexvy was the first RSV vaccine approved in Europe for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 and older, and in those aged 50-59 years who are at increased risk for RSV disease.
Additionally, depemokimab received a positive opinion for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps.
The CHMP also recommended approving Nucala (mepolizumab) as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease.
The opinion covers Nucala in combination with an inhaled corticosteroid, a long-acting beta2-agonist, and a long-acting muscarinic antagonist.
GSK Price Action: GSK shares were down 0.28% at $48.74 at the time of publication on Friday. The stock is trading near its 52-week high of $49.31, according to Benzinga Pro data.
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