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WALTHAM, Mass. & GENEVA - The U.S. Food and Drug Administration has granted Priority Review for zoliflodacin, an investigational oral antibiotic for treating uncomplicated gonorrhea, according to a press release from Innoviva Specialty Therapeutics and the Global Antibiotic Research & Development Partnership (GARDP).
The FDA has assigned a target action date of December 15, 2025, for the New Drug Application. The agency is expected to notify Innoviva regarding a potential Advisory Committee Meeting in its Day 74 letter. The company’s solid financial position, with a healthy current ratio of 2.48 and revenue growth of 18.7% over the last twelve months, positions it well for this development phase.
If approved, zoliflodacin would become the first new antibiotic specifically for gonorrhea in decades. The drug is administered as a single oral dose, offering a potentially more convenient alternative to current injectable treatments.
The FDA previously designated zoliflodacin as a Qualified Infectious Disease Product, which enables Priority Review status and Extended Market Exclusivity.
Zoliflodacin works by inhibiting a bacterial enzyme essential for reproduction. In a Phase 3 clinical trial, the drug demonstrated non-inferiority to the current standard treatment of ceftriaxone injection plus oral azithromycin, and was generally well-tolerated with no serious adverse events reported.
Gonorrhea affects approximately 82 million people globally each year and has developed resistance to most antibiotic classes, including ceftriaxone, which has been in use since 1984. The World Health Organization identifies antimicrobial resistance as one of the ten most critical global public health threats.
Entasis Therapeutics, an affiliate of Innoviva Specialty Therapeutics (NASDAQ:INVA), holds commercial rights for zoliflodacin in major markets, while GARDP retains rights in most low and middle-income countries. With analysts forecasting profitability in 2025 and the stock trading near its 52-week high, InvestingPro analysis suggests the company is currently undervalued, making it an interesting watch for investors following the healthcare sector. Get access to 12 additional ProTips and comprehensive financial analysis with an InvestingPro subscription.
In other recent news, Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., has announced that the U.S. Food and Drug Administration has accepted a New Drug Application for zoliflodacin, a novel oral antibiotic aimed at treating uncomplicated gonorrhea. This development is significant as drug-resistant strains of gonorrhea have been rising, presenting major public health challenges. The FDA’s decision is based on data from multiple clinical trials, including a pivotal Phase 3 trial that demonstrated zoliflodacin’s effectiveness in achieving microbiological cure rates comparable to current treatments. The drug was well-received in trials, with no serious adverse events reported. If approved, zoliflodacin would be the first new treatment option for gonorrhea in many years, offering a single oral dose that could simplify treatment. The FDA has granted the drug a Qualified Infectious Disease Product designation, which includes benefits such as Priority Review. Innoviva anticipates a standard review process, with Entasis Therapeutics, Inc. holding commercial rights in key markets and GARDP focusing on access in low and middle-income countries. This marks a critical step in combating antimicrobial resistance, with potential global implications.
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