DUBLIN - Iterum Therapeutics plc (NASDAQ:ITRM), a pharmaceutical company engaged in the development of antibiotics, announced today its plans to resubmit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its oral antibiotic sulopenem earlier than initially planned.
The company targets the first half of Q2 2024 for the resubmission, aiming to address the deficiencies cited by the FDA in a Complete Response Letter received in July 2021.
If the resubmission successfully addresses the FDA's concerns, Iterum anticipates the FDA's review and decision could be completed by the first half of Q4 2024. This expedited timeline is significant as sulopenem is intended to treat infections caused by multi-drug resistant pathogens, a growing concern in public health.
Iterum also reported a strong financial position, with sufficient cash reserves to fund operations into 2025. This includes the expected Prescription Drug User Fee Act date for sulopenem, which is projected for the first half of Q4 2024. The company's financial stability is attributed to its cash, cash equivalents, and short-term investments as of December 31, 2023, along with net proceeds from recent share sales.
In January 2024, Iterum released positive top-line results from its REASSURE trial. As a strategic move, the company is now exploring options to sell, license, or otherwise dispose of its rights to sulopenem, aiming to maximize stakeholder value. Iterum plans to hire a financial advisor to assist its management and board in evaluating potential strategic alternatives.
Sulopenem, Iterum's leading compound in Phase 3 development, has shown potent activity against a range of resistant bacteria. The oral and IV formulations of sulopenem have received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA for seven indications.
This announcement is based on a press release statement from Iterum Therapeutics plc. The company continues to work on advancing its anti-infectives to address the challenge of drug-resistant infections globally.
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