Iterum Therapeutics Reports FDA Advisory Committee Discussion Of Oral Sulopenem; FDA Decision Expected By PDUFA Goal Date Of October 25, 2024
Portfolio Pulse from Benzinga Newsdesk
Iterum Therapeutics announced that the FDA Antimicrobial Drugs Advisory Committee discussed their new drug application for oral sulopenem, a treatment for uncomplicated urinary tract infections in adult women. The FDA's decision is expected by October 25, 2024.
September 10, 2024 | 11:06 am
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Iterum Therapeutics' oral sulopenem was discussed by the FDA Advisory Committee, highlighting its potential as a treatment for uUTIs. The FDA decision is anticipated by October 25, 2024, which could significantly impact Iterum's market position.
The FDA Advisory Committee's discussion of Iterum's oral sulopenem is a critical step towards potential approval. A positive FDA decision could enhance Iterum's market position and drive stock price up, given the drug's importance in treating uUTIs.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100