Iterum Therapeutics Plc

Iterum Therapeutics Plc operates as a pharmaceutical company, which engages in the development and commercialization of sulopenem to be potentially the first and only oral and intravenous branded penem available. The company was founded by Corey N. Fishman on June 24, 2015 and is headquartered in Dublin, Ireland.

Earnings data Q1 2021

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Iterum Therapeutics progresses with sulopenem, faces regulatory challenges

Iterum Therapeutics (ITRM) showcased progress in key areas like FDA interactions, patent approvals, and maintaining a strong financial position.
While challenges exist in regulatory approval and funding, the company's strategic vision and commitment to growth offer opportunities for success.
Overall, Iterum's focus on advancing sulopenem for uncomplicated UTIs and engaging with the FDA reflects a promising trajectory for future growth.

Iterum Therapeutics reports improved Q3 performance with ORLYNVAH FDA approval

Iterum Therapeutics showed improved financials with lower expenses and a better net loss.
ORLYNVAH's FDA approval and market exclusivity offer growth potential in addressing UTIs.
Challenges lie in maintaining market exclusivity, international expansion, and strategic partnerships.
Opportunities include leveraging ORLYNVAH's approval, expanding internationally, and forming key partnerships.

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Iterum Therapeutics Plc operates as a pharmaceutical company, which engages in the development and commercialization of sulopenem. The company was founded by Corey N. Fishman on June 24, 2015 and is headquartered in Dublin, Ireland.

Iterum Therapeutics plc (NASDAQ: ITRM) has received a Complete Response Letter (CRL) from the FDA regarding its marketing application seeking approval for sulopenem etzadroxil/probenecid (oral sulopenem). The FDA determined that additional data are necessary to support approval for the treatment of adult women with uncomplicated urinary tract infections caused by designated susceptible microorganisms proven or strongly suspected to be non-susceptible to a quinolone (board-spectrum antibiotic).

Iterum Therapeutics Stock Plunges After FDA Rejects Its Sulopenem Application

DUBLIN, Ireland and CHICAGO, July 26, 2021 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) on July 23, 2021. The CRL provided that the FDA has completed its review of the NDA and has determined that it cannot approve the NDA in its present form.

Iterum Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Oral Sulopenem

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NEW YORK, July 7, 2021 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Iterum Therapeutics plc ("Iterum" or the "Company") (NASDAQ: ITRM). Such investors are advised to contact Robert S.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Iterum Therapeutics plc (ITRM)

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Iterum looked to be on track for a July 25 PDUFA for its first commercial drug, sulopenem. Now, the company faces uncertainty as the FDA has issued a letter seeking labeling clarification.

Despite Risks Around Regulatory Approval, Iterum Therapeutics Rates A Speculative Buy

A lack of clarity and final decision in the U.S. Food and Drug Administration's (FDA) recent letter to Iterum Therapeutics PLC (NASDAQ:ITRM) failed to deter H.C. Wainwright & Co's bullish sentiment on Iterum stock.

Iterum Therapeutics Analyst Remains Bullish Despite Concerns Over FDA Letter

The company received disappointing news from the FDA.

Why Iterum Therapeutics Stock Is Crashing Today

The stock price of Iterum Therapeutics PLC (NASDAQ: ITRM) fell by over 39% pre-market. This is why it happened.

ITRM Stock Price Falls Over 39% Pre-Market: Why It Happened

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ITRM Stock Price Increased 90.74% This Past Month: Why It Happened

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Iterum Therapeutics plc (NASDAQ: ITRM) has concluded a late-cycle meeting with the FDA related to its application for sulopenem etzadroxil/probenecid. Sulopenem is under review as a treatment for uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen.

Iterum Therapeutics Stock Shoots Higher As Sulopenem Application Review On Track

DUBLIN, Ireland and CHICAGO, May 27, 2021 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that the Company participated in a late-cycle meeting with the U.S. Food and Drug Administration (“FDA”) yesterday. During the meeting, the FDA shared issues still under review regarding the Company's new drug application (“NDA”) for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen and the Company responded to these issues. The FDA has determined that an Advisory Committee meeting is not currently necessary. The review of the NDA is ongoing and the Company was informed that the FDA continues to work toward the PDUFA goal date of July 25, 2021.

Iterum Therapeutics Provides Update on NDA Review

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Iterum Therapeutics plc (ITRM) CEO Corey Fishman on Q1 2021 Results - Earnings Call Transcript

News for Iterum Therapeutics Plc Stock (ITRM)