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Iterum Therapeutics’ Strategic Advances with ORLYNVAH Approval
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Iterum Therapeutics’ Strategic Advances with ORLYNVAH Approval

Iterum Therapeutics ( (ITRM) ) has released its Q3 earnings. Here is a breakdown of the information Iterum Therapeutics presented to its investors.

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Iterum Therapeutics plc is a pharmaceutical company focused on developing oral and intravenous antibiotics to combat multi-drug resistant infections, emphasizing its novel oral penem antibiotic, ORLYNVAH™.

In its latest earnings report, Iterum Therapeutics announced the FDA approval of ORLYNVAH™ for treating uncomplicated urinary tract infections (uUTI) in adult women, marking a significant milestone as the first branded uUTI product approved in the U.S. in over 25 years. The approval has brought new opportunities for strategic partnerships to address the unmet needs in the antibiotic-resistant uUTI market.

Financially, Iterum reported a net loss of $6.1 million for the third quarter of 2024, compared to a $3.9 million loss in the same period last year. However, the non-GAAP net loss showed an improvement, decreasing from $15.7 million in 2023 to $4.8 million in 2024. The company’s cash reserves stood at $14.5 million, expected to support operations into 2025, including the repayment of exchangeable notes.

Strategically, Iterum has secured additional marketing exclusivity for ORLYNVAH™ under the GAIN Act, enhancing its market position with 10 years of exclusivity. The company is actively engaging with potential partners to maximize the commercial potential of ORLYNVAH™, leveraging its listing in the FDA’s Orange Book.

Looking forward, Iterum’s management remains focused on the commercialization and strategic options for ORLYNVAH™, aiming to expand its market presence and address the challenges posed by antibiotic resistance in the uUTI market.

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