- After three missed endpoints in three pivotal trials, Iterum's antibiotic treatment Sulopenem displayed superiority over standard-of-care Cipro in uUTI patients with quinolone resistant pathogens.
- Iterum has submitted its NDA to the FDA, which has been accepted for priority review, with a decision date set for late July.
- Management are eyeing a potential $6.5bn market, and peak sales ~$1bn, but successful antibiotics treatments typically make sales ~$300m.
- Iterum stock has been on a recent bull run to ~$2.4, from $1.23, and if Sulopenem is approved, the share price ought to challenge May 20 highs of ~$4.2.
- There's significant risk associated with an investment in Iterum, but the upside price catalysts are clear. Post approval it will be a hard slog for the company but an oral penem antibiotic has exciting potential.
For further details see:
Iterum Therapeutics: Sulopenem Approval Decision In July Is Make Or Break