Innoviva Reports Positive Phase 3 Results for Zoliflodacin in Treating Gonorrhea
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 12 2025
0mins
Source: Businesswire
- Clinical Trial Success: Innoviva's single-dose oral antibiotic Zoliflodacin demonstrated non-inferiority to a dual therapy regimen in a pivotal Phase 3 trial involving 930 participants, marking a significant advancement in treatment options for uncomplicated gonorrhea.
- Global Health Impact: With over 82 million new gonorrhea infections annually, the successful development of Zoliflodacin addresses the urgent need for new therapies to combat antimicrobial resistance, highlighting its public health significance.
- FDA Recognition: Zoliflodacin has received Qualified Infectious Disease Product (QIDP) designation from the U.S. FDA, allowing for priority review and extended market exclusivity, with a New Drug Application review target date set for December 15, 2025, enhancing its market potential.
- Research Support: The trial was funded by multiple government entities, underscoring the importance of international collaboration in tackling global antibiotic resistance challenges and potentially fostering the development of more innovative treatments in the future.
Discover Tomorrow's Bullish Stocks Today
Receive free daily stock recommendations and professional analysis to optimize your portfolio's potential.
Sign up now to unlock expert insights and stay one step ahead of the market trends.
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: 19.750
Low
31.00
Averages
37.33
High
46.00
Current: 19.750
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.
Continue Reading
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.
Continue Reading