regulatory
confidence high
sentiment neutral
materiality 0.75
Iterum expects NDA resubmission for oral sulopenem in Q2 2024; cash runway into 2025
Iterum Therapeutics plc
- NDA resubmission for oral sulopenem to FDA expected in first half of Q2 2024, earlier than originally planned.
- FDA action expected six months after resubmission (first half of Q4 2024), assuming deficiencies addressed.
- Cash and equivalents as of Dec 31, 2023 plus ATM proceeds through Feb 29, 2024 expected to fund ops into 2025, including through PDUFA date.
- Company plans to engage financial advisor to assist with strategic alternatives (sale, license, or disposal of rights to sulopenem).