Sulopenem

H.C. Wainwright's Ed Arce maintains Buy rating on Iterum Therapeutics (ITRM) due to sulopenem's potential approval for uUTIs in adult women, despite AMR concerns. The Antimicrobial Drugs Advisory Committee supports a restrictive label to limit off-label use, emphasizing sulopenem's benefits in specific populations and its role against ESBL-producing organisms. The FDA's expected approval, with potential limitations, bolsters Iterum's market position.

The FDA Antimicrobial Drugs Advisory Committee discusses the NDA for oral sulopenem for treating uUTI in adults, addressing antimicrobial stewardship and target patient populations. The PDUFA date is October 25, 2024. Oral sulopenem shows superiority in treating uUTI caused by resistant bacteria, with a need for new, safe, and effective treatment options due to rising AMR rates.

FDA reviewers express concerns over the benefits vs. risks of sulopenem etzadroxil/probenecid, a novel oral antibiotic for uncomplicated urinary tract infections (uUTIs), ahead of an advisory committee meeting. The drug, with activity against gram-positive, gram-negative, and anaerobic organisms, was rejected in 2021 but resubmitted by Iterum Therapeutics in April after another phase III trial. The new trial data showed non-inferiority to amoxicillin/clavulanate but had a small sample size of resistant organisms, raising efficacy questions. The FDA warns of potential inappropriate use and antimicrobial resistance (AMR) risks, emphasizing the need for careful stewardship and guideline considerations.

Dasiglucagon for congenital hyperinsulinism has a PDUFA date of October 8, 2024, supported by phase 3 trials. Perioperative nivolumab-based regimen for resectable NSCLC also has a PDUFA date of October 8, 2024, based on the CheckMate -77T trial. Oclaiz (CAM2029) for acromegaly has a PDUFA date of October 21, 2024, supported by phase 3 studies. Sulopenem etzadroxil/probenecid for uncomplicated UTI has a PDUFA date of October 25, 2024, with data from the REASSURE trial.

Iterum Therapeutics discussed Q2 2024 financials, highlighting a $5.8M rights offering, upcoming FDA meetings for oral sulopenem approval, and patent advancements. With $11.7M cash, they aim to fund operations into 2025, focusing on strategic processes and potential FDA approval by October 2024.

Iterum Therapeutics' NDA resubmission for oral sulopenem to treat uncomplicated urinary tract infections in adult women is accepted by the FDA, with a PDUFA action date of October 25, 2024.

Iterum Therapeutics resubmits NDA to FDA for oral sulopenem to treat uncomplicated urinary tract infections in adult women, with data from phase 3 clinical trials demonstrating its efficacy and safety.

H.C. Wainwright upgraded Iterum Therapeutics to Buy, setting a $6.00 price target after its oral sulopenem antibiotic showed superior results in a Phase 3 trial for uUTI treatment, with FDA approval expected by Q4 2024. Despite positive trial outcomes, Iterum faces financial challenges, including cash burn and lack of profitability.