Welcome to our dedicated page for Innoviva news (Ticker: INVA), a resource for investors and traders seeking the latest updates and insights on Innoviva stock.
Innoviva, Inc. (NASDAQ: INVA) is a diversified healthcare holding company whose news flow reflects its dual focus on royalty-based income and commercial-stage infectious disease and critical care therapies. Company announcements frequently highlight performance of its royalties portfolio tied to GSK respiratory products RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®, alongside updates from Innoviva Specialty Therapeutics (IST), its critical care and infectious disease platform.
News releases from Innoviva and IST cover quarterly financial results, including royalty revenue and net product sales, as well as regulatory milestones and product launches. Examples include FDA acceptance and Priority Review of the New Drug Application for zoliflodacin, subsequent FDA approval of NUZOLVENCE® (zoliflodacin) for uncomplicated urogenital gonorrhea, and the U.S. launch of ZEVTERA® (ceftobiprole) for serious bacterial infections such as Staphylococcus aureus bloodstream infections, ABSSSI, and CABP.
Investors and healthcare professionals can also find coverage of clinical and scientific data presentations at major conferences like IDWeek, where Innoviva Specialty Therapeutics presents Phase 3 results, subgroup analyses, pharmacokinetic-pharmacodynamic studies, and microbiologic surveillance for agents including zoliflodacin, ZEVTERA, XACDURO®, and XERAVA®. Additional news items describe capital allocation decisions, such as share repurchase authorizations, strategic investments in healthcare companies, and licensing or acquisition of new platforms and assets.
This INVA news page aggregates these updates in one place, making it easier to track earnings announcements, regulatory decisions, conference presentations, and portfolio developments. Readers interested in Innoviva’s evolving role in respiratory royalties, antibiotic development, and critical care therapeutics can use this feed to monitor key events and company disclosures over time.
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Innoviva announced that the FDA's Antimicrobial Drugs Advisory Committee unanimously supported the New Drug Application (NDA) for sulbactam-durlobactam. This drug aims to treat adults with hospital-acquired bacterial pneumonia and ventilator-associated pneumonia caused by the Acinetobacter baumannii-calcoaceticus complex. The NDA was accepted in November 2022 and is under Priority Review, with a PDUFA action date set for May 29, 2023.
The Committee's favorable recommendation was based on a Phase 3 trial, demonstrating non-inferiority to colistin and a better safety profile, particularly a lower incidence of nephrotoxicity. The urgent need for effective treatments against drug-resistant Acinetobacter infections highlights the significance of this development.
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Innoviva, Inc. (NASDAQ: INVA) announced that the U.S. FDA's Antimicrobial Drugs Advisory Committee will meet on April 17, 2023, to review the NDA for sulbactam-durlobactam (SUL-DUR), an investigational antibiotic targeting infections caused by drug-resistant Acinetobacter. The Phase 3 trial of SUL-DUR showed non-inferiority to colistin, with significant clinical cure rates and lower nephrotoxicity. The NDA, filed on September 29, 2022, is under Priority Review, with a PDUFA date set for May 29, 2023. This highlights the urgency of addressing serious infections due to Acinetobacter, designated as an urgent public health threat by the CDC.