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Iterum Therapeutics plc Ordinary Share - $ITRM STOCK NEWS

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Iterum Therapeutics plc (Nasdaq: ITRM) will report its first quarter 2024 financial results on May 13, 2024. The company focuses on developing oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens. A conference call will be held to discuss financial results and business updates.

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2.58%
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Iterum Therapeutics has resubmitted its New Drug Application for oral sulopenem to the U.S. FDA for the treatment of uncomplicated urinary tract infections. The potential approval of oral sulopenem, the first oral penem in the U.S. and the second new oral treatment for uUTIs in over 25 years, could benefit an estimated 40 million women suffering from uUTIs annually in the U.S. The NDA resubmission includes data from phase 3 clinical trials showing oral sulopenem's efficacy and safety, positioning it as a promising new antibiotic option.

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Iterum Therapeutics plc (Nasdaq: ITRM) reported positive topline data from its REASSURE trial for the treatment of adult women with uncomplicated urinary tract infections (uUTIs). They plan to resubmit the NDA early in Q2 2024. The company's cash runway extends into 2025, including potential FDA approval in early Q4 2024. Iterum is engaged in a strategic process to sell, license, or dispose of rights to sulopenem to maximize shareholder value.
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Iterum Therapeutics plc (ITRM) to Release Q4 and Full Year 2023 Financial Results, Host Conference Call on March 28, 2024
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1.27%
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Iterum Therapeutics plc (ITRM) to participate in H.C. Wainwright @Home Fireside Chat to discuss oral sulopenem program for UTIs.
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Iterum Therapeutics plc (ITRM) plans to resubmit its NDA for oral sulopenem to the FDA in the first half of Q2 2024, with an extended cash runway into 2025. Positive top-line results from the REASSURE trial were announced in January 2024, leading to a strategic evaluation of selling or licensing sulopenem.
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Iterum Therapeutics plc announced positive results from the REASSURE Phase 3 clinical trial comparing oral sulopenem to oral Augmentin® in treating uUTIs. The results showed that sulopenem was non-inferior to Augmentin®, with a statistically significant superiority of sulopenem. Iterum plans to resubmit the NDA for sulopenem in Q2 2024 and is focusing on a strategic process to sell, license, or dispose of its rights to sulopenem to maximize value for stakeholders.
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Iterum Therapeutics plc (Nasdaq: ITRM) has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. The Company was previously notified that it was not in compliance because its ordinary shares failed to meet the closing bid price of $1.00 or more for 30 consecutive business days. Iterum was provided with 180 calendar days to regain compliance and successfully met the requirement on November 30, 2023.
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Iterum Therapeutics plc (Nasdaq: ITRM) reported financial results for Q3 2023, completed enrollment of 2,229 patients in REASSURE trial for uUTI treatment, expects top-line data in Q1 2024, plans NDA resubmission in Q2 2024. New patents granted in Korea and Australia. Cash, cash equivalents, and short-term investments at $35.9 million as of September 30, 2023. R&D expenses increased to $14.9 million, G&A expenses decreased to $1.8 million. Net loss for Q3 2023 was $3.9 million. Conference call scheduled for November 14, 2023.
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Iterum Therapeutics plc (Nasdaq: ITRM) will release its third quarter 2023 financial results on Tuesday, November 14, 2023, before the open of the U.S. financial markets. A conference call will be held at 8:30 a.m. ET on the same day to discuss the results and provide a business update.
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Iterum Therapeutics plc Ordinary Share

Nasdaq:ITRM

ITRM Rankings

ITRM Stock Data

26.49M
15.34M
1.52%
7.57%
7.46%
Pharmaceutical Preparation Manufacturing
Manufacturing
Link
United States of America
DUBLIN 2

About ITRM

iterum therapeutics plc is an ireland-based clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives. these products are aimed at combatting the global crisis of multi-drug resistant (mdr) pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. iterum’s first product is a novel anti-infective compound that has demonstrated potent in-vitro activity vs. a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. for more information on iterum therapeutics please visit www.iterumtx.com.