GSK Secures FDA Nod for Oral Antibiotic to Treat Urinary Tract Infection

GSK plc GSK announced that the FDA has approved its oral antibiotic gepotidacin for treating uncomplicated urinary tract infections (uUTIs) in female adults and adolescents. A commercial launch for the drug is planned in second-half 2025 under the brand name Blujepa.This approval for Blujepa marks the introduction of a new class of oral antibiotics for uUTIs in nearly 30 years. Per GSK, the drug targets a different part of the bacteria than most existing antibiotics, making it effective against resistant strains. Additionally, the risk of bacterial resistance is low, as mutations would need to occur in both enzymes that Blujepa targets.The drug has been designed to treat uUTIs caused by susceptible microorganisms like Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis.GSK Stock’s PerformanceYear to date, shares of GSK have gained 14% compared with the industry’s 6% growth.Image Source: Zacks Investment ResearchMore on GSK’s BlujepaThe FDA approval is supported by data from two late-stage studies, EAGLE-2 and EAGLE-3, which showed that Blujepa is at least as effective as nitrofurantoin, a leading standard-of-care (SOC) therapy for uUTIs. In EAGLE-2, the drug met its primary goal of non-inferiority, with a therapeutic success rate of 50.6% versus 47.0% for nitrofurantoin. Data from the EAGLE-3 study showed Blujepa’s superiority, with a success rate of 58.5% compared to 43.6% for nitrofurantoin.Besides uUTI, GSK is also evaluating the safety and efficacy of Blujepa to ceftriaxone plus azithromycin in patients with uncomplicated urogenital gonorrhoea caused by Neisseria gonorrhoeae.The drug is one of five new products/line extensions GSK expects this year, potentially boosting its bottom line amid declining vaccine sales. Other planned launches include Blenrep (for multiple myeloma), depemokimab (chronic rhinosinusitis with nasal polyps and asthma with type II inflammation), Nucala (for chronic obstructive pulmonary disease) and the pentavalent MenABCWY meningococcal vaccine.Blujepa has been developed internally by GSK scientists, with part-funding from the U.S. government.GSK’s Zacks RankGSK currently carries a Zacks Rank #3 (Hold).GSK PLC Sponsored ADR Price GSK PLC Sponsored ADR price | GSK PLC Sponsored ADR QuoteKey Picks Among Biotech StocksSome better-ranked stocks from the sector are ANI Pharmaceuticals ANIP, CytomX Therapeutics CTMX and 89bio ETNB. While ANIP and CTMX sport a Zacks Rank #1 (Strong Buy) each at present, ETNB carries a Zacks Rank #2 (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 risen from $5.54 to $6.35. EPS estimates for 2026 have increased from $6.75 to $7.21 during the same period. Year to date, shares of ANIP have risen 20%.ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 17.32%.In the past 60 days, estimates for CytomX Therapeutics’ 2025 EPS have improved from a loss of 31 cents to earnings of 25 cents. During the same timeframe, estimates for loss per share for 2026 have narrowed from 65 cents to 31 cents. Year to date, shares of CytomX have lost 40%.CTMX’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 180.70%.Estimates for 89bio’s loss per share have narrowed from $3.07 to $1.98 for 2025 in the past 60 days. During the same time frame, loss per share estimates for 2026 have improved from $2.49 to $2.15. ETNB’s shares have gained more than 2% year to date.89bio’s earnings missed estimates in three of the trailing four quarters and beat the mark on one occasion, delivering an average negative surprise of 46.18%.Zacks Names #1 Semiconductor StockIt's only 1/9,000th the size of NVIDIA which skyrocketed more than +800% since we recommended it. NVIDIA is still strong, but our new top chip stock has much more room to boom.With strong earnings growth and an expanding customer base, it's positioned to feed the rampant demand for Artificial Intelligence, Machine Learning, and Internet of Things. Global semiconductor manufacturing is projected to explode from $452 billion in 2021 to $803 billion by 2028.See This Stock Now for Free >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK): Free Stock Analysis Report ANI Pharmaceuticals, Inc. (ANIP): Free Stock Analysis Report CytomX Therapeutics, Inc. (CTMX): Free Stock Analysis Report 89BIO (ETNB): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks