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GSK Gets FDA Nod for Blujepa in Uncomplicated Urogenital Gonorrhea
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Key Takeaways
GSK secures FDA approval for Blujepa to treat uncomplicated urogenital gonorrhea.
The approval is based on EAGLE-1 data showing non-inferiority to standard combination therapy.
Study results also highlighted Blujepa's favorable safety and tolerability profile.
GSK plc (GSK - Free Report) announced that the FDA has approved its supplemental new drug application (sNDA) seeking approval for its oral antibiotic Blujepa (gepotidacin) for treating uncomplicated urogenital gonorrhea (uGC) in adult and pediatric patients.
The regulatory body has now approved Blujepa as an oral option for adult and pediatric patients aged 12 years and above weighing at least 45 kg who have limited or no alternative options for the treatment of uGC, which is caused by susceptible strains of Neisseria gonorrhoeae.
The latest nod for Blujepa marks the approval of a first new class of antibiotic for gonorrhea in more than 30 years. Blujepa also provides a new oral alternative to existing injectable treatments for patients with gonorrhea in the United States.
The FDA approved Blujepa for treating uncomplicated urinary tract infections (uUTIs) in female adults and pediatric patients in March 2025.
GSK’s Price Performance
Year to date, shares of GSK have gained 44.6% compared with the industry’s 18.3% growth.
Image Source: Zacks Investment Research
More on the Latest Nod to GSK’s Blujepa
Gonorrhea is a common sexually transmitted infection caused by Neisseria gonorrhoeae, which has been identified as a priority pathogen by the World Health Organization. The U.S. Centers for Disease Control and Prevention (CDC) has classified the infection as an urgent public health threat.
The above sNDA was based on positive data from the phase III EAGLE-1 study, which showed that treatment with Blujepa was non-inferior to standard of care combination treatment for gonorrhea (intramuscular ceftriaxone plus oral azithromycin).
The results also reinforced Blujepa’s safety and tolerability, as no serious drug-related side effects were observed.
In August 2025, the FDA accepted and granted priority review to GSK’s sNDA for Blujepa as an oral treatment of uGC.
Blujepa has been developed by GSK with part-funding from the U.S. government.
In 2025, GSK had set a target to launch five new products/line extensions, including Blenrep, depemokimab (severe asthma and CRSwNP), Nucala for COPD, Penmenvy and Blujepa. Of these, Penmenvy, Blujepa, Blenrep and Nucala for COPD are already approved in the United States with the FDA decision on depemokimab expected before year-end.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have increased from $7.29 to $7.54. EPS estimates for 2026 have moved up from $7.79 to $8.15 during the same period. ANIP stock has surged 48.6% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 21.24%.
In the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87. EPS estimates for 2026 have moved up from $2.49 to $2.88 during the same period. CRMD stock has surged 44.9% in the past year.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.
In the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from 65 cents to 34 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from $2.10 to $1.06. Year to date, shares of CSTL have rallied 42.5%.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 66.11%.
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GSK Gets FDA Nod for Blujepa in Uncomplicated Urogenital Gonorrhea
Key Takeaways
GSK plc (GSK - Free Report) announced that the FDA has approved its supplemental new drug application (sNDA) seeking approval for its oral antibiotic Blujepa (gepotidacin) for treating uncomplicated urogenital gonorrhea (uGC) in adult and pediatric patients.
The regulatory body has now approved Blujepa as an oral option for adult and pediatric patients aged 12 years and above weighing at least 45 kg who have limited or no alternative options for the treatment of uGC, which is caused by susceptible strains of Neisseria gonorrhoeae.
The latest nod for Blujepa marks the approval of a first new class of antibiotic for gonorrhea in more than 30 years. Blujepa also provides a new oral alternative to existing injectable treatments for patients with gonorrhea in the United States.
The FDA approved Blujepa for treating uncomplicated urinary tract infections (uUTIs) in female adults and pediatric patients in March 2025.
GSK’s Price Performance
Year to date, shares of GSK have gained 44.6% compared with the industry’s 18.3% growth.
Image Source: Zacks Investment Research
More on the Latest Nod to GSK’s Blujepa
Gonorrhea is a common sexually transmitted infection caused by Neisseria gonorrhoeae, which has been identified as a priority pathogen by the World Health Organization. The U.S. Centers for Disease Control and Prevention (CDC) has classified the infection as an urgent public health threat.
The above sNDA was based on positive data from the phase III EAGLE-1 study, which showed that treatment with Blujepa was non-inferior to standard of care combination treatment for gonorrhea (intramuscular ceftriaxone plus oral azithromycin).
The results also reinforced Blujepa’s safety and tolerability, as no serious drug-related side effects were observed.
In August 2025, the FDA accepted and granted priority review to GSK’s sNDA for Blujepa as an oral treatment of uGC.
Blujepa has been developed by GSK with part-funding from the U.S. government.
In 2025, GSK had set a target to launch five new products/line extensions, including Blenrep, depemokimab (severe asthma and CRSwNP), Nucala for COPD, Penmenvy and Blujepa. Of these, Penmenvy, Blujepa, Blenrep and Nucala for COPD are already approved in the United States with the FDA decision on depemokimab expected before year-end.
GSK’s Zacks Rank & Stocks to Consider
GSK currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals (ANIP - Free Report) CorMedix (CRMD - Free Report) and Castle Biosciences (CSTL - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have increased from $7.29 to $7.54. EPS estimates for 2026 have moved up from $7.79 to $8.15 during the same period. ANIP stock has surged 48.6% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 21.24%.
In the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87. EPS estimates for 2026 have moved up from $2.49 to $2.88 during the same period. CRMD stock has surged 44.9% in the past year.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.
In the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from 65 cents to 34 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from $2.10 to $1.06. Year to date, shares of CSTL have rallied 42.5%.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 66.11%.