ITRM Posts Updates From FDA Advisory Meeting for UTI Drug, Stock Down

Core Viewpoint - Iterum Therapeutics plc is awaiting a decision from the FDA regarding its new drug application for oral sulopenem, which is intended for the treatment of uncomplicated urinary tract infections in adult women, with a decision expected on October 25, 2024 [5] Group 1: FDA Meeting and Drug Application - The FDA's Antimicrobial Drugs Advisory Committee (AMDAC) met on September 9 to evaluate the benefits and risks of oral sulopenem for treating urinary tract infections in women over 18 years old [2] - AMDAC acknowledged oral sulopenem as an important treatment option and emphasized the need for proper use to limit antimicrobial resistance [4] - The FDA did not request a vote from the AMDAC during the meeting [2] Group 2: Market Reaction and Stock Performance - Following the AMDAC meeting, Iterum's stock fell by 12% on September 10, reflecting investor concerns about the potential limitations on sulopenem's approval [3] - Year-to-date, Iterum's shares have decreased by 51.8%, contrasting with a minor industry decline of 0.8% [3] Group 3: Previous Regulatory Challenges - In 2021, Iterum received a complete response letter from the FDA regarding its initial NDA for oral sulopenem, indicating that additional data was required for approval [7] - The company resubmitted the NDA based on positive results from the pivotal REASSURE study announced in January 2024 [8] Group 4: Competitive Landscape - Iterum currently holds a Zacks Rank of 2 (Buy), while other biotech stocks like Illumina, Krystal Biotech, and Fulcrum Therapeutics have higher rankings of 1 (Strong Buy) [9]