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Iterum Therapeutics Stock Forum
Iterum Therapeutics Receives FDA Acceptance of Resubmission of NDA for Oral Sulopenem for the treatment of Uncomplicated Urinary Tract Infections
Iterum Therapeutics announced that the FDA has accepted the resubmission of its New Drug Application (NDA) for oral sulopenem, aimed at treating uncomplicated urinary tract infections (uUTIs) in adult women. The FDA has assigned a PDUFA action date of October 25, 2024. This milestone follows the REASSURE clinical tria...
NEWS
Iterum Therapeutics Resubmits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem
Dow Jones· 2 mins ago
In today's volatile market, discerning investors are constantly on the lookout for promising ventures that offer a strong return potential. One such opportunity that has piqued interest is Iterum Therapeutics (NASDAQ: $ITRM), a clinical-stage pharmaceutical company focused on developing anti-infectives to combat multi-drug resistant pathogens. Recently, HC Wainwright...
• The company said that the filing would address the concerns the regulator raised in July 2021 when it declined to approve the product. At the time, the company targeted sulopenem for patients with urinary tract infections caused by quinolone non-susceptible pathogens.