Sulbactam

Innoviva Reports Fourth Quarter and Full Year 2023 Financial Results; Highlights Recent Company Progress

Retrieved on: 
Thursday, February 29, 2024

Pavel Raifeld, Chief Executive Officer of Innoviva, said: “2023 was a successful and transformational year for Innoviva.

Key Points: 
  • Pavel Raifeld, Chief Executive Officer of Innoviva, said: “2023 was a successful and transformational year for Innoviva.
  • Share repurchase: During the fourth quarter 2023, Innoviva repurchased 1,121,835 shares of its outstanding common stock for $15.4 million.
  • Our portfolio of strategic assets under the Company’s various subsidiaries was valued at $561.0 million as of December 31, 2023.
  • In fourth quarter 2023, Innoviva invested an additional $5.0 million in one of our assets, Gate Neurosciences, to support its strategy of developing next generation targeted CNS therapies.

Innoviva Reports Third Quarter 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Wednesday, November 1, 2023

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.

Key Points: 
  • 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.
  • "The third quarter of 2023 was marked by significant revenues stemming from our royalty portfolio and solid performance by our internal product portfolio,” said Pavel Raifeld, Chief Executive Officer of Innoviva.
  • During the third quarter of 2023, Innoviva repurchased 856,750 shares of its outstanding common stock for $11.0 million.
  • On August 21, 2023, Innoviva appointed Stephen Basso as Chief Financial Officer.

Innoviva Specialty Therapeutics Presents New Data on its Critical Care Antibiotic Therapy Portfolio at Infectious Disease Week (IDWeek) 2023

Retrieved on: 
Wednesday, October 11, 2023

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA), announced today plans to present an oral abstract and four poster sessions from their portfolio of U.S. Food and Drug Administration (FDA)-approved critical care and infectious disease therapies at IDWeek 2023, October 11-15, held in Boston, MA.

Key Points: 
  • Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA), announced today plans to present an oral abstract and four poster sessions from their portfolio of U.S. Food and Drug Administration (FDA)-approved critical care and infectious disease therapies at IDWeek 2023, October 11-15, held in Boston, MA.
  • XACDURO is indicated in adults for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.
  • In addition, four company-sponsored research studies on XACDURO will also be presented by the company’s research partners in poster sessions.
  • “Antibiotic-resistant pathogens are one of the most significant and challenging threats to healthcare providers on the frontlines of infectious disease care,” said Margaret Koziel, MD, Chief Medical Officer, Innoviva Specialty Therapeutics.

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

Retrieved on: 
Monday, September 18, 2023

The Acinetobacter pathogen has become resistant to most antibiotics used to treat HABP and VABP including carbapenems and third generation cephalosporins.

Key Points: 
  • The Acinetobacter pathogen has become resistant to most antibiotics used to treat HABP and VABP including carbapenems and third generation cephalosporins.
  • This has caused Acinetobacter to become increasingly difficult to treat with no clear standard of care antibiotic regimen for these resistant infections.
  • “Every minute matters when managing critical care patients with life-threatening pneumonia, especially when caused by carbapenem-resistant Acinetobacter baumannii pathogen.
  • Antibiotic-resistant pathogens can complicate treatment strategies and compromise treatment efficacy, often resulting in increased mortality rates for intensive care unit patients,” said Margaret Koziel, MD, Chief Medical Officer, Innoviva.

Innoviva Reports Second Quarter 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Wednesday, August 2, 2023

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.

Key Points: 
  • 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.
  • Net income was $1.3 million, or $0.02 basic per share, for the second quarter of 2023, compared to net income of $0.9 million, or $0.01 basic per share, for the second quarter of 2022.
  • During the second quarter of 2023, Innoviva repurchased 775,504 shares of its outstanding common stock for $9.2 million.
  • On July 11, 2023, Innoviva director, Deborah Birx, resigned from Innoviva Board and joined Armata as Chief Executive Officer.

Innoviva Specialty Therapeutics Announces FDA Approval for XACDURO® (sulbactam for injection; durlobactam for injection), Co-packaged for Intravenous Use

Retrieved on: 
Tuesday, May 23, 2023

Innoviva Specialty Therapeutics is focused on delivering innovative therapies in critical care and infectious disease.

Key Points: 
  • Innoviva Specialty Therapeutics is focused on delivering innovative therapies in critical care and infectious disease.
  • “XACDURO is the first pathogen-targeted therapy approved to treat hospital-acquired and ventilator-associated pneumonias caused by Acinetobacter.
  • The FDA approval of XACDURO marks an important milestone in our aim to deliver differentiated therapies to critically ill patients who have limited treatment options,” said David Altarac, MD, Chief Medical Officer, Innoviva Specialty Therapeutics.
  • “Acinetobacter poses a significant danger to hospitalized patients, who are generally very ill and particularly susceptible to infections.

FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria

Retrieved on: 
Tuesday, May 23, 2023

"Today's approval helps address a high unmet medical need by providing an additional treatment option for some of the sickest patients in our nation's hospitals."

Key Points: 
  • "Today's approval helps address a high unmet medical need by providing an additional treatment option for some of the sickest patients in our nation's hospitals."
  • Acinetobacter baumannii-calcoaceticus complex (henceforth referred to as A. baumannii) includes four species of bacteria in the Acinetobacter family.
  • These bacteria can cause infections in various parts of the body, occurring most frequently in healthcare settings and predominantly causing pneumonia.
  • A. baumannii can become highly resistant to multiple antibacterial drugs and current treatment options for drug-resistant A. baumannii are limited.

Zai Lab Announces NDA Acceptance of Sulbactam-Durlobactam (SUL-DUR) for Infections Caused by Acinetobacter baumannii in China by the NMPA

Retrieved on: 
Wednesday, February 22, 2023

“We are pleased to obtain the NMPA’s acceptance of our submission for the registration of SUL-DUR, an intravenous (IV) antibiotic combination for patients with Acinetobacter infections including multidrug and carbapenem-resistant strains.

Key Points: 
  • “We are pleased to obtain the NMPA’s acceptance of our submission for the registration of SUL-DUR, an intravenous (IV) antibiotic combination for patients with Acinetobacter infections including multidrug and carbapenem-resistant strains.
  • SUL-DUR is poised to address a clear unmet medical need as patients face very limited treatment options with this pathogen, which causes serious infections with high mortality.
  • “The ATTACK trial has shown SUL-DUR treated patients have lower mortality and less renal toxicity compared to standard-of-care colistin therapy.
  • Zai Lab participated in the global ATTACK study by enrolling trial patients in China.

Innoviva Announces FDA Acceptance and Priority Review of New Drug Application for Sulbactam-Durlobactam (SUL-DUR)

Retrieved on: 
Wednesday, November 30, 2022

The Agency is currently planning to hold an advisory committee meeting to discuss this application.

Key Points: 
  • The Agency is currently planning to hold an advisory committee meeting to discuss this application.
  • SUL-DUR also exhibited a favorable safety profile with statistically significant reduction in nephrotoxicity.
  • Carbapenem-resistant and multidrug-resistant Acinetobacter infections are an urgent and emergent threat due to increasing rates of resistance and few viable treatment options.
  • Our focused and dedicated team looks forward to continuing to work with the FDA throughout the priority review process.

Entasis Therapeutics, a Wholly Owned Subsidiary of Innoviva, Presents Efficacy and Safety Data from Landmark Phase 3 ATTACK Trial at IDWEEK 2022

Retrieved on: 
Wednesday, October 19, 2022

Results showed that ABC isolates from patients in ATTACK were highly antibiotic-resistant, but >95% susceptible to SUL-DUR.

Key Points: 
  • Results showed that ABC isolates from patients in ATTACK were highly antibiotic-resistant, but >95% susceptible to SUL-DUR.
  • This study evaluated PPK in 373 subjects, including 110 patients who received SUL-DUR and underwent PK sampling in the pivotal Phase 3 ATTACK trial.
  • In addition to the oral presentations, three poster presentations highlighted additional SUL-DUR and ATTACK trial details and results.
  • All Entasis IDWeek 2022 presentations will be made available on the Entasis website https://www.entasistx.com/our-science/presentations-by-event.