Innoviva Stock Price, News & Analysis

Innoviva Specialty Therapeutics (NASDAQ: INVA) will present new analyses from the pivotal Phase 3 trial of zoliflodacin, a single‑dose oral antibiotic for uncomplicated gonorrhea, at IDWeek 2025 in Atlanta, October 19–22, 2025.

Three presentations include two posters (P-1206, P-1207 on Oct 21) and an oral presentation (Oct 22) reporting high microbiological cure rates across urogenital, rectal, and pharyngeal sites for isolates with zoliflodacin MIC ≤0.25 µg/mL. Urogenital cure rates were 96.6% (346/358; 95% CI 94.2–98.3) for ciprofloxacin‑resistant strains and 97.4% (113/116; 95% CI 92.6–99.5) for ciprofloxacin‑susceptible strains. Posters show comparable zoliflodacin MICs across demographic groups and stable potency in U.S. 2022 isolates versus 2020–2021.

Innoviva Specialty Therapeutics (NASDAQ: INVA) will present six scientific items from its infectious diseases and critical care portfolio at IDWeek 2025 in Atlanta, October 19–22, 2025. Presentations include clinical data, PK‑PD analyses, and microbiologic surveillance on zoliflodacin, ceftobiprole, sulbactam‑durlobactam, and eravacycline.

Highlights: an oral subset analysis from the Phase 3 zoliflodacin trial (Oct 22) and an oral PK‑PD target attainment analysis for ceftobiprole in Staphylococcus aureus bacteremia (Oct 22). Multiple poster presentations on pediatric pharmacokinetics and U.S. zoliflodacin activity are scheduled Oct 20–22. Visit booth #1231 for more information.

Innoviva (NASDAQ: INVA), a diversified holding company, has announced its participation in four major investor conferences in September 2025. The company will engage in fireside chats at Citi's Biopharma Back to School Conference (Sept 2), the Wells Fargo Healthcare Conference (Sept 3), and the Cantor Global Healthcare Conference (Sept 4), followed by a corporate presentation at the H.C. Wainwright Global Investment Conference (Sept 8).

All presentations will be accessible via live webcast through Innoviva's investor relations website, with archived replays available after the events.

Innoviva Specialty Therapeutics (NASDAQ: INVA) announced that its two antimicrobial therapies, ZEVTERA® and XACDURO®, have been nominated for the 2025 Prix Galien USA "Best Pharmaceutical Product" Award, often considered the Nobel Prize equivalent in biopharmaceutical research.

ZEVTERA, FDA-approved in April 2024, is the first advanced-generation cephalosporin approved for Staphylococcus aureus bloodstream infections, including MRSA strains. XACDURO, approved in May 2023, is the first and only antibiotic approved for treating hospital-acquired and ventilator-associated bacterial pneumonia caused by Acinetobacter.

The company is also awaiting FDA decision on zoliflodacin, an investigational therapy for uncomplicated gonorrhea, expected by end of 2025.

Innoviva (NASDAQ: INVA) reported strong Q2 2025 financial results, with total royalty revenue of $67.3 million from GSK and net product sales of $35.5 million. The company achieved net income of $63.7 million ($1.01 per share), compared to a net loss in Q2 2024.

Key highlights include the U.S. launch of ZEVTERA, their fourth product and first FDA-approved cephalosporin for MRSA-related bacteremia. Additionally, the FDA accepted the NDA for zoliflodacin with Priority Review, setting a PDUFA date of December 15, 2025. U.S. net product sales showed impressive growth of 54% year-over-year, led by GIAPREZA ($17.0M) and XACDURO ($8.5M).

The company maintains a strong financial position with $397.5 million in cash and cash equivalents, plus $88.3 million in receivables as of June 30, 2025.

The FDA has granted Priority Review for Innoviva Specialty Therapeutics' New Drug Application for zoliflodacin, a novel oral antibiotic designed to treat uncomplicated gonorrhea. The FDA set a PDUFA target date of December 15, 2025, for this first-in-class, single-dose treatment. If approved, zoliflodacin would become the first new gonorrhea antibiotic in decades. The drug has received Qualified Infectious Disease Product designation, providing benefits including Priority Review and Extended Market Exclusivity. Entasis Therapeutics holds commercial rights in major markets across North America, Europe, and Asia-Pacific, while GARDP maintains rights in most low and middle-income countries. The treatment targets adults and pediatric patients 12 years and older.

The FDA has accepted Innoviva Specialty Therapeutics' New Drug Application for zoliflodacin, a groundbreaking oral antibiotic for treating uncomplicated gonorrhea in patients 12 years and older. If approved, zoliflodacin would be the first new gonorrhea antibiotic in decades, offering a single-dose oral treatment option against multidrug-resistant strains. The drug's Phase 3 trial demonstrated non-inferiority to current treatment (ceftriaxone injection plus oral azithromycin) and was well-tolerated. Zoliflodacin works by inhibiting type II topoisomerase enzyme and has shown effectiveness against resistant strains in laboratory studies. The FDA granted it Qualified Infectious Disease Product designation, enabling Priority Review and Extended Market Exclusivity. This development addresses a critical global health need, as gonorrhea affects 82 million people annually and has become increasingly resistant to existing treatments.

Innoviva (NASDAQ: INVA), a diversified holding company, announced its participation in two upcoming investor conferences in June 2025. The company will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference on June 9 at 1:20 p.m. ET, which will be available via webcast on the company's investor relations website. Additionally, Innoviva will attend the Scotiabank Third Annual Healthcare Canadian Investor Day on June 17 for one-on-one meetings. Innoviva's business includes a core royalties portfolio, the Innoviva Specialty Therapeutics platform focused on critical care and infectious diseases, and strategic healthcare investments.

Innoviva Specialty Therapeutics announces the U.S. commercial launch of ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic. ZEVTERA is the first and only FDA-approved cephalosporin for treating three types of bacterial infections, including Staphylococcus aureus bacteremia (SAB) with right-sided endocarditis caused by MRSA. The drug demonstrated non-inferiority to daptomycin in Phase 3 ERADICATE study, with success rates of 69.8% vs 68.7%. ZEVTERA received Priority Review, Fast Track, and Qualified Infectious Disease Product designations. This marks Innoviva's second novel therapy launch in two years targeting drug-resistant pathogens. The drug addresses a significant medical need, as over 100,000 people in the U.S. experience bacteremia annually, with nearly 20,000 deaths. Innoviva acquired exclusive U.S. marketing rights from Basilea Pharmaceutica in December 2024.