H.C. Wainwright Upgrades Iterum Therapeutics (ITRM) to Buy

H.C. Wainwright analyst Ed Arce upgraded Iterum Therapeutics (NASDAQ: ITRM) from Neutral to Buy with a price target of $6.00.

The analyst comments "Sulopenem met superiority on the study's primary endpoint. On January 30, Iterum announced positive top-line data from the REASSURE (NCT05584657) pivotal Phase 3 trial of oral sulopenem (sulopenem etzadroxil and probenecid combination) for the treatment of uncomplicated urinary tract infections (uUTI). Sulopenem successfully achieved non-inferiority vs. Augmentin, with 61.7% vs. 55.0% of patients achieving overall response (clinical success plus microbiologic eradication) at the test-of-cure (TOC) visit in the microbiological-modified-intent-to-treat susceptible (m-MITTS) population, the primary endpoint of the REASSURE trial (Exhibit 1). Specifically, clinical cure is defined as the resolution of symptoms with no new symptoms, while microbiologic eradication is defined as a urine culture of <103 colonyforming unit (CFU) per mL. For the primary endpoint, non-inferiority and superiority is reached if the lower bound of the 95% confidence interval (CI) of sulopenem over Augmentin is >-10% and >0%, respectively. To that end, the lower limit of the 95% CI around the treatment difference of 0.3 indicates statistical superiority of oral sulopenem over Augmentin on overall response (Exhibit 2), exceeding our expectation for noninferiority. Sulopenem also met two additional key secondary endpoints in REASSURE: clinical success at TOC, and microbiologic eradication at TOC. Beyond these top-line results, Iterum plans to present complete results from the REASSURE trial at an upcoming scientific meeting. Given that REASSURE was designed in agreement with the FDA under a special protocol assessment (SPA), we believe sulopenem is likely to be approved by the FDA in 4Q24, or about 6 months after an NDA resubmission currently expected in 2Q24. As such, we are upgrading our rating for ITRM shares to Buy, with a $6 price target."

For an analyst ratings summary and ratings history on Iterum Therapeutics click here. For more ratings news on Iterum Therapeutics click here.

Shares of Iterum Therapeutics closed at $1.58 yesterday.

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