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.
Summary not available.
Summary not available.
Summary not available.
Summary not available.
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.
Summary not available.
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.
Innoviva, Inc. (NASDAQ: INVA) reported fourth quarter 2022 financial results, highlighting royalties of $54.7 million and net product sales of $14.6 million. The income before taxes dropped to a loss of $64.7 million, down from a profit of $56.5 million in the same quarter of 2021, largely due to decreased royalty revenues post-divestiture of Theravance Respiratory Company. Despite challenges, GIAPREZA and XERAVA posted their strongest sales. The company initiated a $100 million share repurchase program and appointed Dr. Sapna Srivastava to its Board of Directors.
Armata Pharmaceuticals announced the closing of a secured convertible credit agreement with Innoviva Strategic Opportunities, providing $30 million in gross proceeds. The company plans to utilize these funds for the clinical development of AP-PA02 and AP-SA02, along with constructing a cGMP manufacturing facility. The one-year term loan features an 8.0% interest rate and is secured by nearly all of Armata's assets. Conversion of the loan into shares will occur during qualified financing or at Innoviva's option after a resale registration statement is effective.
Innoviva has announced that the FDA has accepted the NDA for SUL-DUR, a targeted antibiotic for treating serious infections caused by Acinetobacter baumannii complex. This drug aims to address the urgent public health threat posed by multidrug-resistant strains. The NDA is based on the Phase 3 ATTACK trial, showing SUL-DUR's non-inferiority to colistin in reducing 28-day mortality and a significant improvement in clinical cure rates. The FDA's priority review takes place with a target action date of May 29, 2023.
FAQ
What is the current stock price of Innoviva (INVA)?
What is the market cap of Innoviva (INVA)?
