LOGIN  |  REGISTER
Amneal Pharmaceuticals
Cue Biopharma

Iterum Therapeutics to Host Morning Conference Call on U.S. FDA Approval of ORLYNVAH™ (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections

October 28, 2024 | Last Trade: US$1.77 0.02 1.14
  • Monday, October 28, 2024, at 8:30 a.m. EDT

DUBLIN and CHICAGO, Oct. 28, 2024 /PRNewswire/ --

WHO:

Iterum Therapeutics plc (Nasdaq: ITRM) is focused on delivering differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world.

WHAT

Conference call to discuss U.S. Food and Drug Administration (FDA) approval of Iterum's ORLYNVAH™ (Oral Sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs).

Speakers include: Corey Fishman (CEO) and Steve Aronin (Senior Vice President and Head of Clinical Development)

WHY:

ORLYNVAH™ (sulopenem etzadroxil and probenecid) is the first oral penem approved for use in the U.S. and the first FDA-approved product for Iterum. ORLYNVAH™ is approved for the treatment of uUTIs caused by the designated
microorganisms Escherichia coli, Klebsiella pneumoniae or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. It is only the second FDA-approved treatment for uUTIs in the past two
decades.

For more details, view the press release issued Friday here.

WHEN: 

Monday, October 28, 2024
8:30 a.m. Eastern Daylight Time

 

Dial-in information:
United States: +1 833-470-1428 | International: +1 404-975-4839
Access code: 936149 

 

The conference call replay will be available in the Events & Presentations page of Iterum's website following the call.

About Iterum Therapeutics plc

Iterum Therapeutics plc is focused on delivering differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum is advancing the development of its first compound, sulopenem, a novel penem anti-infective compound, with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum has received approval of its NDA for ORLYNVAH™ (oral sulopenem) for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited or no alternative oral antibacterial treatment options by the U.S. Food and Drug Administration and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. For more information, please visit www.iterumtx.com.

Assertio

Stock Quote

Featured Stock

Cue Biopharma

Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...

CLICK TO LEARN MORE

Featured Stock

Terns Pharmaceuticals

Terns Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including GLP-1 receptor...

CLICK TO LEARN MORE

End of content

No more pages to load

Next page

COPYRIGHT ©2023 HEALTH STOCKS HUB