Iterum Therapeutics PLC 8-K filings
Iterum Therapeutics has commenced a rights offering to raise capital by distributing subscription rights to shareholders and eligible warrant holders.
Iterum Therapeutics has announced July 16, 2024, as the record date for its rights offering, aiming to raise capital through the sale of units consisting of ordinary shares and warrants.
8-K: Iterum Therapeutics Faces FDA Advisory Committee for Oral Sulopenem, Sets September Meeting Date
Iterum Therapeutics' oral sulopenem NDA for uncomplicated urinary tract infections will be reviewed by an FDA Advisory Committee on September 9, 2024.
Iterum Therapeutics has received FDA acceptance for its oral sulopenem NDA resubmission with a PDUFA action date set for October 25, 2024, and has been granted a Nasdaq compliance extension until September 30, 2024.
8-K: Iterum Therapeutics Reports Q1 2024 Financials, NDA Resubmitted with FDA Action Expected in Early Q4
Iterum Therapeutics announced its first quarter 2024 financial results, highlighted by the resubmission of its New Drug Application (NDA) for oral sulopenem and an extended cash runway into 2025.
Iterum Therapeutics' Chief Medical Officer, Sailaja Puttagunta, M.D., has resigned effective May 31, 2024, due to personal reasons.
Iterum Therapeutics has resubmitted its New Drug Application to the FDA for oral sulopenem, a potential new treatment for uncomplicated urinary tract infections in adult women.
Iterum Therapeutics received a notice from Nasdaq for failing to meet minimum stockholders' equity requirements, placing its listing status at risk.
Iterum Therapeutics announced its fourth quarter and full year 2023 financial results, highlighted by progress on its NDA resubmission for sulopenem and an extended cash runway into 2025.
Iterum Therapeutics plans to resubmit its new drug application for oral sulopenem earlier than expected and believes its current cash will fund operations into 2025.
Iterum Therapeutics shareholders voted against a proposal that would have allowed the company to issue 5 million ordinary shares for cash without first offering them to existing shareholders.
Iterum Therapeutics' oral sulopenem demonstrated statistical superiority over Augmentin in a Phase 3 trial for uncomplicated urinary tract infections, paving the way for a potential NDA resubmission and strategic review.