Iterum Therapeutics plc (ITRM)

Iterum Therapeutics plc is an Irish pharmaceutical company founded in 2015 and headquartered in Dublin, Ireland, with U.S. operations in Illinois. It was formed to develop sulopenem, an antibiotic in the penem class that was available in both oral and intravenous forms. The company was focused on infections caused by drug-resistant bacteria.

Iterum listed its ordinary shares on Nasdaq in 2018 under the symbol ITRM. Its early development programs for sulopenem addressed uncomplicated urinary tract infections, complicated urinary tract infections, and complicated intra-abdominal infections. Clinical trials in the complicated indications did not meet their goals, and the company narrowed its efforts toward uncomplicated urinary tract infections.

The company ran a Phase 3 program for oral sulopenem in uncomplicated urinary tract infections and received a complete response letter from the FDA before an additional trial, which produced positive results. The FDA approved oral sulopenem, marketed as Orlynvah, in October 2024 for uncomplicated urinary tract infections caused by certain bacteria in adult women with limited or no alternative oral options.

Orlynvah launched commercially in August 2025, roughly a year after approval. The FDA approval described it as the first oral penem antibiotic. Initial sales were modest relative to launch expenses, with about $400,000 in sales in the first quarter on the market against several million dollars in expenses. Management had projected 2026 sales in the range of $5 million to $15 million.

Iterum had limited cash and reported substantial net losses, and it faced a Nasdaq listing deficiency. On February 24, 2026, Nasdaq staff notified the company that it no longer qualified for listing under Listing Rule 5550(a)(2). The company appealed to the Hearings Panel on March 3, 2026, but withdrew the appeal on March 27, 2026.

On March 27, 2026, Iterum filed a petition with the Irish High Court to wind up the company, citing its dwindling cash, its inability to regain Nasdaq compliance, and its inability to complete a sale of Orlynvah after talks with potential buyers. On March 30, 2026, Nasdaq informed the company that its shares would be suspended. Trading was suspended on April 1, 2026.

Nasdaq issued its delisting determination on May 11, 2026, and removal from listing took effect at the opening of trading on July 6, 2026. After the suspension, the ordinary shares were quoted over the counter under the symbol ITRMF. The delisting was not part of an acquisition or merger. The wind-up petition and the loss of the Nasdaq listing mean that holders of the ordinary shares face substantial uncertainty about any recovery, and the over-the-counter quotation offers only limited liquidity.