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. Common Stock (INVA) is an innovative biopharmaceutical company focused on bringing compelling new medicines to patients in areas of unmet need. Leveraging its significant expertise in development, commercialization, and financial management, Innoviva has established a diverse portfolio that includes royalty assets and strategic healthcare investments.
Innoviva's primary assets are anchored in respiratory therapies, specifically those partnered with Glaxo Group Limited (GSK). The company is entitled to receive royalty revenues from key products such as Relvar®/Breo® Ellipta®, Anoro® Ellipta®, and potentially VI monotherapy if approved and commercialized. These products were jointly developed with GSK, showcasing a strong collaboration that significantly contributes to Innoviva's revenue stream.
In addition to its respiratory portfolio, Innoviva holds a 15% economic interest in future payments made by GSK for early-stage programs partnered with Theravance Biopharma, Inc. This strategic investment underlines Innoviva's commitment to fostering innovation in the biopharmaceutical industry.
More recently, Innoviva has expanded its footprint in critical care and infectious diseases through strategic acquisitions and partnerships. Notably, the company, via its subsidiary Innoviva Strategic Opportunities LLC, has entered into a secured credit agreement with Armata Pharmaceuticals, Inc., providing $35 million to advance Armata's lead therapeutic phage candidates. This financing underscores Innoviva's dedication to supporting groundbreaking therapies for antibiotic-resistant infections.
Furthermore, Innoviva’s product offerings extend beyond respiratory treatments to include other critical healthcare assets, such as Trelegy Ellipta®. The company's well-rounded portfolio ensures a balanced approach to addressing various healthcare challenges.
Innoviva continually strives to maximize shareholder value through strategic investments and partnerships, robust financial performance, and a commitment to advancing innovative medical solutions. For more detailed information about Innoviva, please visit their official website at www.inva.com.
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.
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.
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