Second Most Prevalent Bacterial Sexually Transmitted Infection: GSK's Gonorrhea Vaccine Secures FDA Track
Portfolio Pulse from Vandana Singh
The FDA has granted Fast Track designation to GSK plc's investigational vaccine for Neisseria gonorrhea, which is currently in an ongoing Phase 2 trial. Gonorrhea is the second most prevalent bacterial sexually transmitted infection worldwide, with an estimated 82 million new cases yearly. There are no approved vaccines for gonorrhea, and antimicrobial resistance to existing treatments is increasing.

June 27, 2023 | 11:35 am
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GSK's investigational gonorrhea vaccine has received Fast Track designation from the FDA, potentially giving the company a competitive edge in the market for gonorrhea treatments.
The Fast Track designation for GSK's investigational gonorrhea vaccine indicates that the FDA recognizes the potential of the vaccine to address an unmet medical need. With no approved vaccines for gonorrhea and increasing antimicrobial resistance, a successful vaccine could give GSK a significant advantage in the market for gonorrhea treatments. This news is likely to have a positive short-term impact on GSK's stock price.
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