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Innoviva, Inc. - Common Stock (INVA)

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+0.18 (0.84%)
NASDAQ · Last Trade: Jun 12th, 3:35 PM EDT
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FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025
Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for zoliflodacin, an investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. The FDA assigned a target action date of December 15, 2025 under the Prescription Drug User-Fee Act (PDUFA). It is expected the FDA will notify Innoviva Specialty Therapeutics regarding the FDA’s decision to conduct an Advisory Committee Meeting in the Day 74 letter. If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades.
Innoviva Specialty Therapeutics Receives FDA New Drug Application Acceptance for Zoliflodacin, a First-in-Class Oral Antibiotic for Uncomplicated Gonorrhea in Adults
Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for zoliflodacin, the investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades.
By Innoviva, Inc. · Via Business Wire · June 10, 2025
Innoviva to Participate in Upcoming Investor Conferences
Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today announced that management will participate in the following upcoming investor conferences in June:
By Innoviva, Inc. · Via Business Wire · June 3, 2025
ZEVTERA® (ceftobiprole), an Advanced-Generation Cephalosporin Antibiotic Now Commercially Available in the U.S. to Treat Three Types of Bacterial Infections
Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced the United States commercial availability of ZEVTERA® (ceftobiprole medocaril sodium for injection), the newest addition to the Company’s growing antibiotic portfolio. ZEVTERA is the only U.S. Food and Drug Administration (FDA) approved advanced-generation cephalosporin indicated to treat adult patients with Staphylococcus aureus bloodstream infection (bacteremia) (SAB), including those with right-side endocarditis caused by methicillin-susceptible and methicillin-resistant isolates.i ZEVTERA is the latest approved MRSA SAB therapy since 2006.
Innoviva Reports First Quarter 2025 Financial Results; Highlights Recent Company Progress
Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today reported financial results for the first quarter ended March 31, 2025, and highlighted select corporate progress and achievements.
By Innoviva, Inc. · Via Business Wire · May 7, 2025
Innoviva to Participate in the Barclays 27th Annual Global Healthcare Conference
Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today announced that Pavel Raifeld, Chief Executive Officer, will participate in a fireside chat at the Barclays 27th Annual Global Healthcare Conference in Miami, FL on Tuesday, March 11, 2025 at 8:30 a.m. Eastern Time.
By Innoviva, Inc. · Via Business Wire · March 5, 2025
Innoviva Reports Fourth Quarter and Full Year 2024 Financial Results; Highlights Recent Company Progress
Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today reported financial results for the fourth quarter and full year ended December 31, 2024, and highlighted select corporate progress and achievements.
By Innoviva, Inc. · Via Business Wire · February 26, 2025
Innoviva to Participate in the Oppenheimer 35th Annual Healthcare Life Sciences Conference
Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today announced that Pavel Raifeld, Chief Executive Officer, will participate in a podium presentation at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on Tuesday, February 11, 2025 at 2:00 p.m. Eastern Time. The conference will be held in a virtual format.
By Innoviva, Inc. · Via Business Wire · February 6, 2025
Innoviva Specialty Therapeutics Signs Exclusive Distribution and Licensing Agreement to Acquire U.S. Marketing Rights for Zevtera® (ceftobiprole)
Innoviva Specialty Therapeutics, Inc., (“IST”) a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced it has entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), for the commercialization of Zevtera® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the United States.
By Innoviva, Inc. · Via Business Wire · December 16, 2024
Innoviva to Participate in the Citi 2024 Global Healthcare Conference
Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today announced that Pavel Raifeld, Chief Executive Officer, will participate in a fireside chat at the Citi 2024 Global Healthcare Conference in Miami, FL on Thursday, December 5, 2024 at 8:45 a.m. Eastern Time.
By Innoviva, Inc. · Via Business Wire · November 26, 2024
Innoviva to Participate in the UBS Global Healthcare Conference
Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today announced that management will participate in a fireside chat at the UBS Global Healthcare Conference in Ranch Palos Verdes, CA on Wednesday, November 13, 2024 at 10:15 a.m. Pacific Time.
By Innoviva, Inc. · Via Business Wire · November 12, 2024
Innoviva Reports Third Quarter 2024 Financial Results; Highlights Recent Company Progress
Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today reported financial results for the third quarter ended September 30, 2024, and highlighted select corporate achievements.
By Innoviva, Inc. · Via Business Wire · November 6, 2024
Innoviva to Participate in Upcoming Investor Conferences
Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today announced that management will participate in the following upcoming investor conferences in September:
By Innoviva, Inc. · Via Business Wire · September 4, 2024
Innoviva Reports Second Quarter 2024 Financial Results; Highlights Recent Company Progress
Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today reported financial results for the second quarter ended June 30, 2024, and highlighted select corporate achievements.
By Innoviva, Inc. · Via Business Wire · July 31, 2024
Innoviva to Participate in the Goldman Sachs 45th Annual Global Healthcare Conference
Innoviva, Inc. (Nasdaq: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today announced that Pavel Raifeld, Chief Executive Officer, will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference in Miami, FL on Monday, June 10, 2024 at 1:20 p.m. Eastern Time.
By Innoviva, Inc. · Via Business Wire · June 3, 2024
Innoviva Reports First Quarter 2024 Financial Results; Highlights Recent Company Progress
Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today reported financial results for the first quarter ended March 31, 2024, and highlighted select corporate achievements.
By Innoviva, Inc. · Via Business Wire · May 8, 2024
Innoviva to Participate in the BofA Securities Health Care Conference
Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today announced that Pavel Raifeld, Chief Executive Officer, will present at the BofA Securities Health Care Conference in Las Vegas, NV on Wednesday, May 15, 2024 at 9:20 a.m. Pacific Daylight Time.
By Innoviva, Inc. · Via Business Wire · May 8, 2024
Innoviva Specialty Therapeutics’ Positive Phase 3 Oral Zoliflodacin Data for the Treatment of Uncomplicated Gonorrhea Announced at ESCMID Global 2024
Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), today announced that positive results from the Phase 3 oral zoliflodacin trial will be highlighted in an oral presentation given by the Global Antibiotic Research & Development Partnership (GARDP) at the European Society of Clinical Microbiology and Infectious Disease Global Congress (ESCMID Global 2024) taking place April 27-30, 2024, in Barcelona, Spain. Zoliflodacin is a first-in-class spiropyrimidinetrione, single dose, oral antibiotic that is being developed in partnership with GARDP for the treatment of uncomplicated gonorrhea.
Innoviva Reports Fourth Quarter and Full Year 2023 Financial Results; Highlights Recent Company Progress
Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today reported financial results for the fourth quarter and full year ended December 31, 2023 and highlighted select corporate achievements.
By Innoviva, Inc. · Via Business Wire · February 29, 2024
Innoviva Reports Third Quarter 2023 Financial Results and Highlights Recent Company Progress
Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a portfolio of royalties and other healthcare assets, today reported financial results for the third quarter ended September 30, 2023, highlighted select corporate achievements and provided an overview of its key business initiatives.
By Innoviva, Inc. · Via Business Wire · November 1, 2023
Positive Results Announced in Largest Pivotal Phase 3 Trial of a First-in-Class Oral Antibiotic to Treat Uncomplicated Gonorrhea
The Global Antibiotic Research & Development Partnership (GARDP), in collaboration with Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA), announced today that zoliflodacin, a first-in-class antibiotic, met its primary endpoint in an unprecedented global pivotal Phase 3 clinical trial. Study investigators found that oral zoliflodacin demonstrated statistical non-inferiority of microbiological cure at the urogenital site when compared to treatment with intramuscular (IM) injection of ceftriaxone and oral azithromycin, a current global standard of care regimen. In the study, zoliflodacin was found to be generally well tolerated and there were no serious adverse events or deaths recorded in the trial.
By Innoviva Specialty Therapeutics · Via Business Wire · November 1, 2023
Innoviva to Participate in the Cantor Global Healthcare Conference
Innoviva, Inc. (Nasdaq: INVA) (“Innoviva”), a diversified holding company with a portfolio of royalties and other healthcare assets, today announced that Pavel Raifeld, Chief Executive Officer, will participate in a fireside chat at the Cantor Global Healthcare Conference in New York, NY on Wednesday, September 27, 2023 at 1:50 p.m. Eastern Time.
By Innoviva, Inc. · Via Business Wire · September 19, 2023
XACDURO®, The First and Only Antibiotic Developed to Target Acinetobacter, Now Available to Treat Hospital-Acquired Bacterial Pneumonia (HABP) and Ventilator-Associated Bacterial Pneumonia (VABP) in Adults
Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced that XACDURO® (sulbactam for injection; durlobactam for injection) is now available in the United States for patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter).
By Innoviva, Inc. · Via Business Wire · September 18, 2023
Innoviva Appoints Stephen Basso as Chief Financial Officer
Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” and “the Company”), a diversified holding company with a portfolio of royalties and other healthcare assets, today announced the appointment of Stephen Basso as its Chief Financial Officer, effective August 21, 2023.
By Innoviva, Inc. · Via Business Wire · August 25, 2023
Innoviva Reports Second Quarter 2023 Financial Results and Highlights Recent Company Progress
Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a portfolio of royalties and other healthcare assets, today reported financial results for the second quarter ended June 30, 2023, highlighted select corporate achievements and provided an overview of its key business initiatives.
By Innoviva, Inc. · Via Business Wire · August 2, 2023