Innoviva Publishes Positive Phase 3 Results for Zoliflodacin in Gonorrhea Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 12 2025
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Source: Newsfilter
- Clinical Trial Success: Innoviva's study demonstrates that zoliflodacin is non-inferior to the combination of ceftriaxone and azithromycin for treating uncomplicated urogenital gonorrhea, with a difference of 5.31% (95% CI 1.38%, 8.65%), laying the groundwork for the development of a novel single-dose oral antibiotic.
- Addressing Resistance: With over 82 million new gonorrhea infections globally each year and rising antimicrobial resistance, the development of zoliflodacin is crucial as it provides clinicians with a new treatment option to combat this public health crisis.
- FDA Recognition: The U.S. FDA has granted zoliflodacin Qualified Infectious Disease Product (QIDP) designation, allowing it to benefit from Priority Review and Extended Market Exclusivity, which will expedite its market entry, with a New Drug Application review expected by December 15, 2025.
- Global Collaborative Support: The study received funding from multiple governments, including Germany, the UK, and Japan, highlighting the international commitment to tackling antibiotic resistance and promoting global public health cooperation and development.
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Analyst Views on INVA
Wall Street analysts forecast INVA stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for INVA is 37.33 USD with a low forecast of 31.00 USD and a high forecast of 46.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 19.550
Low
31.00
Averages
37.33
High
46.00
Current: 19.550
Low
31.00
Averages
37.33
High
46.00
About INVA
Innoviva, Inc. is a diversified holding company with a portfolio of royalties and other healthcare assets. The Company's royalty portfolio consists of respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR/BREO ELLIPTA (fluticasone furoate/vilanterol, FF/VI) and ANORO ELLIPTA (umeclidinium bromide/vilanterol, UMEC/VI). Under the Long-Acting Beta2 Agonist (LABA) Collaboration Agreement, the Company is entitled to receive royalties from GSK on sales of RELVAR/BREO, ELLIPTA. The Company's products include GIAPREZA (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock, and XERAVA (eravacycline) approved for the treatment of complicated intra-abdominal infections in adults. The third product, XACDURO (formerly known as sulbactam-durlobactam or SUL-DUR), is approved for the treatment of hospital-acquired and ventilator-associated pneumonias caused by Acinetobacter in adults. The development pipeline includes zoliflodacin, an investigational treatment for uncomplicated gonorrhea is in Phase III clinical trial.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
INVA Stock Fluctuates: 52-Week Low at $16.52
- Stock Fluctuation: INVA's 52-week low is $16.52, with a high of $22.76, and the last trade at $19.30 indicates volatility within this range, reflecting cautious market sentiment towards the stock.
- Market Trend: The current price of $19.30 is below the 200-day moving average, suggesting a cautious investor sentiment in the short term, necessitating close monitoring of future market performance to assess investment risks.
- Investor Attention: The fluctuation in INVA's stock price may influence investor decisions, especially in the current economic climate, prompting investors to closely watch market dynamics to adjust their strategies.
- Technical Analysis: The stock's movement between $16.52 and $22.76 indicates a divergence in market expectations for INVA's future performance, leading investors to consider technical indicators to guide trading decisions.
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FDA Greenlights Innoviva's NUZOLVENCE, the First Oral Treatment for Gonorrhea
FDA Approval: Innoviva Specialty Therapeutics received FDA approval for NUZOLVENCE (zoliflodacin), a first-in-class oral medication for treating uncomplicated urogenital gonorrhea in patients aged 12 and older.
Clinical Trial Success: The approval was based on the largest Phase 3 clinical trial for a new gonorrhea treatment, conducted in high-prevalence regions across five countries.
Significance of Treatment: NUZOLVENCE is one of the first new treatments for uncomplicated urogenital gonorrhea approved by the FDA in nearly 20 years, addressing a significant public health issue.
Commercialization Plans: Innoviva plans to commercialize NUZOLVENCE in the second half of 2026, either independently or with a partner.
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