GSK's NDA for UTI Drug Gepotidacin Gets FDA's Priority Review [Yahoo! Finance]
ANI Pharmaceuticals, Inc. (ANIP)
Last ani pharmaceuticals, inc. earnings: 2/27 08:30 am
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Source: Yahoo! Finance
for its investigational, first-in-class oral antibiotic, gepotidacin for treating uncomplicated urinary tract infections (uUTIs) in female adults and adolescents. With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on March 26, 2025. If approved, gepotidacin could become the first in a new class of oral antibiotic medicines to be approved for treating uUTIs in more than 20 years. Year to date, shares of GSK have increased 5.8% against the industry's decline of 1.8%. Image Source: Zacks Investment Research GSK's NDA Based on Data from Two Phase III Studies The NDA for gepotidacin was based on data from two pivotal phase III studies — EAGLE-2 and EAGLE-3 — which evaluated the safety and efficacy of gepotidacin versus nitrofurantoin, the current standard of care for uUTI. Within the studies, treatment with gepotidacin demonstrated non-inferiority to nitrofurantoin in female adults with confirmed uUTI and a uropathogen suscepti
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ANIP
Earnings
- 8/6/24 - Beat
ANIP
Sec Filings
- 10/15/24 - Form 4
- 9/20/24 - Form 8-K
- 9/16/24 - Form 4
- ANIP's page on the SEC website