Iterum Therapeutics Tops PRISM Emerging Women’s Health Index, Receives PDUFA Date from FDA

Clinical-stage pharmaceutical company, Iterum Therapeutics (Nasdaq: ITRM), is topping the PRISM Emerging Women’s Health Index on Friday after the company announced that the FDA has

acknowledged receipt of the company’s resubmitted New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. The company’s share price climbed in morning trading, settling up +9.03% at noon.

Iterum stated that under the Prescription Drug User Fee Act (PDUFA), the FDA has deemed the Company’s NDA resubmission to be a Class II complete response which has a six-month review period from the date of resubmission. As a result, the FDA has assigned a PDUFA action date of October 25, 2024.

Corey Fishman, Iterum’s Chief Executive Officer, said, “We are very pleased that the FDA has accepted the resubmission of the NDA for oral sulopenem. This significant milestone brings us one step closer to the potential approval of oral sulopenem for uUTIs providing patients and physicians with a much-needed treatment option for this underserved market. We look forward to continuing to work with the FDA during its review.”

Iterum’s resubmission included supplementary evidence from the REASSURE clinical trial, which compared oral sulopenem to oral Augmentin® in adult women with a uUTI, and demonstrated an overall success rate demonstrating statistically significant superiority of oral sulopenem versus Augmentin®.

About Iterum Therapeutics plc

Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combating 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. The Company is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development 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. The Company has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

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Iterum Therapeutics Tops PRISM Emerging Women’s Health Index, Receives PDUFA Date from FDA

Catie Corcoran

Biotech Editor