Innoviva Stock Price, News & Analysis

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.

Innoviva, Inc. (NASDAQ: INVA) reported third-quarter 2022 revenue of $65.6 million in royalties, just slightly down from $65.7 million in Q3 2021. The income before taxes surged to $286.4 million, driven mainly by a gain from selling a 15% stake in Theravance Respiratory Company. Net cash provided by operating activities reached $192.8 million for the first nine months of 2022. The company completed a $100 million share repurchase program and acquired remaining interests in both Entasis Therapeutics and La Jolla Pharmaceutical. Despite challenges, Innoviva aims to enhance shareholder value with its new growth strategies.

La Jolla Pharmaceutical Company, a subsidiary of Innoviva (NASDAQ: INVA), announced the selection of five abstracts for poster presentation at IDWeek 2022, taking place from October 19-23, 2022, in Washington, D.C. These presentations will focus on XERAVA (eravacycline), an FDA-approved antibacterial for complicated intra-abdominal infections. Notable topics include combination therapy for Clostridioides difficile infection and usage in immunocompromised patients. XERAVA is marketed by Tetraphase Pharmaceuticals in the U.S. and by PAION in Europe.

Innoviva, Inc. (Nasdaq: INVA) announced that CEO Pavel Raifeld will participate in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference on September 14 at 11:10 a.m. Eastern Time. Investors can access a live webcast of the event on the Company's website in the Investor Relations section, with a replay available for 90 days post-event. Innoviva is known for its diversified healthcare assets, including partnerships with GSK.

Innoviva completed its acquisition of La Jolla Pharmaceutical Company after a successful tender offer, purchasing shares at $6.23 each. This deal enhances Innoviva's presence in the hospital and infectious disease sectors, adding marketed products such as GIAPREZA® and XERAVA®. The tender offer saw approximately 87.03% of La Jolla's shares validly tendered, satisfying the required minimum for completion. As a result, La Jolla is now a wholly-owned subsidiary and will be delisted from the Nasdaq, allowing Innoviva to expand its product portfolio in critical healthcare markets.