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GSK's NDA for UTI Drug Gepotidacin Gets FDA's Priority Review
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GSK plc (GSK - Free Report) announced that the FDA has accepted its new drug application (NDA) seeking approval 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 susceptible to nitrofurantoin.
Data from the EAGLE-2 study showed that treatment with gepotidacin resulted in therapeutic success in 50.6% of participants compared to 47% of participants who were treated with nitrofurantoin.
Data from the EAGLE-3 study showed that treatment with gepotidacin resulted in therapeutic success in 58.5% of participants compared to 43.6% of participants who received nitrofurantoin.
Importantly, the safety and tolerability profile of gepotidacin was similar to that seen in previous study data.
Another phase III study called EAGLE-1 is evaluating gepotidacin for treating patients with uncomplicated urogenital gonorrhea caused by Neisseria gonorrhoeae.
Global regulatory filings for gepotidacin in uncomplicated urogenital gonorrhea are expected to be submitted in 2025.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.69 to $4.81. Earnings per share estimates for 2025 have improved from $5.37 to $5.86. Year to date, shares of ANIP have risen 8.2%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Elevation Oncology’s 2024 loss per share have narrowed from 86 cents to 82 cents. Loss per share estimates for 2025 have narrowed from 90 cents to 86 cents. Year to date, shares of ELEV have increased 2.8%.
ELEV’s earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 12.05%.
In the past 60 days, estimates for Voyager Therapeutics’ 2024 loss per share have narrowed from $1.47 to $1.44. Loss per share estimates for 2025 have narrowed from $1.95 to $1.94. Year to date, shares of VYGR have declined 6.2%.
VYGR’s earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 104.33%.
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GSK's NDA for UTI Drug Gepotidacin Gets FDA's Priority Review
GSK plc (GSK - Free Report) announced that the FDA has accepted its new drug application (NDA) seeking approval 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 susceptible to nitrofurantoin.
Data from the EAGLE-2 study showed that treatment with gepotidacin resulted in therapeutic success in 50.6% of participants compared to 47% of participants who were treated with nitrofurantoin.
Data from the EAGLE-3 study showed that treatment with gepotidacin resulted in therapeutic success in 58.5% of participants compared to 43.6% of participants who received nitrofurantoin.
Importantly, the safety and tolerability profile of gepotidacin was similar to that seen in previous study data.
Another phase III study called EAGLE-1 is evaluating gepotidacin for treating patients with uncomplicated urogenital gonorrhea caused by Neisseria gonorrhoeae.
Global regulatory filings for gepotidacin in uncomplicated urogenital gonorrhea are expected to be submitted in 2025.
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, Inc. (ANIP - Free Report) , Elevation Oncology, Inc. and Voyager Therapeutics, Inc. (VYGR - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.69 to $4.81. Earnings per share estimates for 2025 have improved from $5.37 to $5.86. Year to date, shares of ANIP have risen 8.2%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Elevation Oncology’s 2024 loss per share have narrowed from 86 cents to 82 cents. Loss per share estimates for 2025 have narrowed from 90 cents to 86 cents. Year to date, shares of ELEV have increased 2.8%.
ELEV’s earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 12.05%.
In the past 60 days, estimates for Voyager Therapeutics’ 2024 loss per share have narrowed from $1.47 to $1.44. Loss per share estimates for 2025 have narrowed from $1.95 to $1.94. Year to date, shares of VYGR have declined 6.2%.
VYGR’s earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 104.33%.