Iterum receives FDA approval for ORLYNVAH for uUTIs; first product approval

Iterum Therapeutics plc

FDA approved ORLYNVAH (oral sulopenem) for uUTIs in adult women with limited/no alternative oral antibiotics.
Approval based on Phase 3 trials SURE 1 (superior to ciprofloxacin) and REASSURE (non-inferior to Augmentin, statistical superiority).
ORLYNVAH is first oral penem approved in U.S. and Iterum's first FDA-approved product.
Company renews efforts for strategic transaction (sale/partnership/license) involving ORLYNVAH to maximize value.
Approximately 40M uUTI prescriptions annually in U.S.; ~1% resistant to all common oral antibiotics, addressing unmet need.

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