H.C. Wainwright launched coverage of Iterum Therapeutics (NASDAQ:ITRM) with a “buy” rating and $17 price target. The stock closed at $6.60 on June 20.
The company is developing significantly differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant (MDR).
Analyst Ed Arce writes that Iterum is seeking to launch its lead asset, sulopenem, which it licensed from Pfizer, for two distinct commercial opportunities, simultaneously, including complicated urinary tract infection and complicated intra-abdominal infection in hospitalized patients at elevated risk of treatment failure.
In addition, Mr. Arce said the company has a substantial upside opportunity of treating uncomplicated urinary tract infection in the community with a bilayer oral tablet of sulopenem-probenecid, potentially avoiding hospitalization altogether.
“We believe the profile of sulopenem, as a safe and potent member of the proven and trusted penem-class of drugs, is an attractive option in treating these three indications, especially in areas of high quinolone resistance,” he added.
Sulopenem has received qualified infectious disease product designation and fast track status, which should facilitate priority review and a rolling regulatory submission. Mr. Arce said readouts of three Phase 3 trials, all under special protocol assessment, by early 2020 should enable FDA approval by the end of 2020.
