Innoviva Stock Price, News & Analysis

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.

Innoviva (NASDAQ: INVA) reported its Q1 2025 financial results, demonstrating mixed performance. The company's core royalty revenue from GSK remained strong at $61.3M, while Innoviva Specialty Therapeutics achieved $26.4M in U.S. net product sales, marking 52% YoY growth. Despite operational growth with income from operations increasing 61% to $41.4M, the company reported a net loss of $46.6M, primarily due to unfavorable changes in equity investments. Key developments include the upcoming NDA filing for zoliflodacin and planned U.S. launch of ZEVTERA® in mid-2025. The company maintains a strong balance sheet with $319.1M in cash and cash equivalents and continues strategic investments in healthcare assets, valued at $457.6M as of March 31, 2025.

Armata Pharmaceuticals (NYSE American: ARMP) has secured a $10 million credit agreement with Innoviva Strategic Opportunities , its largest shareholder. The loan facility comes with a 14.0% annual interest rate and matures on March 12, 2026.

The proceeds will support the development of Armata's lead therapeutic phage candidates: AP-PA02 targeting Pseudomonas aeruginosa infections and AP-SA02 for Staphylococcus aureus infections. The funding will specifically enable the company to complete its Phase 1b/2a trial in acute Staphylococcus aureus bacteremia and prepare for an end-of-Phase 2 FDA meeting.

Additionally, Armata amended three existing credit agreements with Innoviva, extending their maturity dates to March 12, 2026. The company continues to seek additional funding sources, including non-dilutive options, to support late-stage clinical trials.

Innoviva (NASDAQ: INVA), a diversified holding company, has announced its participation in the Barclays 27th Annual Global Healthcare Conference in Miami, FL. CEO Pavel Raifeld will engage in a fireside chat on Tuesday, March 11, 2025, at 8:30 a.m. Eastern Time.

The company, which maintains a core royalties portfolio and operates the Innoviva Specialty Therapeutics (IST) platform focusing on critical care and infectious diseases, will provide a live webcast of the presentation. Investors can access the webcast through the Investor Relations section of Innoviva's website under 'Events & Presentations' at investor.inva.com/presentations-events. The presentation recording will remain available for replay for 90 days after the event.