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

Rhea-AI Summary

Iterum Therapeutics (Nasdaq: ITRM) announces a conference call on October 28, 2024, at 8:30 a.m. EDT to discuss the FDA approval of ORLYNVAH™ (Oral Sulopenem). This groundbreaking treatment for uncomplicated urinary tract infections (uUTIs) marks two significant milestones: it's the first oral penem approved in the U.S. and Iterum's first FDA-approved product. ORLYNVAH™ is specifically approved for adult women with treatment options, targeting infections caused by specific microorganisms. Notably, it represents only the second FDA-approved uUTI treatment in two decades.

Positive

• First oral penem antibiotic approved in the U.S. market
• First FDA-approved product for Iterum Therapeutics
• Only second FDA-approved treatment for uUTIs in 20 years
• Addresses unmet medical need for women with treatment options

Negative

• market scope (only for adult women with treatment options)
• Restricted to specific microorganisms only

Insights

Medical Research Analyst

The FDA approval of ORLYNVAH™ marks a significant milestone in the antibiotics space. This is the first oral penem antibiotic approved in the U.S. and only the second FDA-approved treatment for uncomplicated UTIs in 20 years. The approval addresses a critical market need, particularly for patients with treatment options due to antibiotic resistance.

The drug's effectiveness against specific bacteria strains (E. coli, K. pneumoniae and P. mirabilis) positions it well in the UTI treatment landscape. For Iterum, with a market cap of just $42.4M, this approval could substantially impact revenues and market position. The timing is important given the growing concern over antibiotic resistance and the pipeline of new antibiotics.

Market Research Analyst

This FDA approval represents a transformative moment for Iterum Therapeutics, being their first FDA-approved product. The UTI treatment market is substantial, with over 10 million cases annually in the U.S. alone. The approval could significantly boost Iterum's commercial prospects, especially given the competition in this space.

The company's transition from a development-stage to a commercial-stage organization will likely attract increased investor interest. Watch for upcoming details about commercialization strategy, pricing and market penetration plans during the conference call. The small market cap suggests significant potential upside if the commercial launch proves successful.

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.

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SOURCE Iterum Therapeutics plc

FAQ

What is ORLYNVAH and what was it approved for by the FDA?

ORLYNVAH (sulopenem etzadroxil and probenecid) is the first oral penem antibiotic approved by the FDA for treating uncomplicated urinary tract infections in adult women with treatment options.

Which bacteria can ITRM's ORLYNVAH treat?

ORLYNVAH is approved to treat infections caused by three specific microorganisms: Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis.

When did Iterum Therapeutics (ITRM) receive FDA approval for ORLYNVAH?

Iterum Therapeutics received FDA approval for ORLYNVAH prior to their announced conference call scheduled for October 28, 2024.

How significant is ORLYNVAH's FDA approval for urinary tract infections?

ORLYNVAH's approval is highly significant as it's only the second FDA-approved treatment for uncomplicated urinary tract infections in the past two decades and the first oral penem approved in the U.S.