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.

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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.

FDA Review of NDA for Oral Sulopenem Continues; Current Prescription Drug User Fee Act (PDUFA) date of July 25, 2021

Iterum Therapeutics Reports First Quarter 2021 Financial Results

DUBLIN, Ireland and CHICAGO, May 07, 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 will release its first quarter 2021 financial results before the open of the U.S. financial markets on Friday, May 14, 2021. Management will host a conference call at 8:30 a.m. ET that day to discuss the Company's financial results and provide an update on its business.

Iterum Therapeutics to Provide Business Update and Report First Quarter 2021 Financial Results on May 14, 2021

Iterum Therapeutics plc is a small late-clinical-stage pharmaceutical company developing Sulopenem, their lead and sole therapeutic for urinary tract and intra-abdominal infections. Iterum has tested their sole candidate Sulopenem in 3 simultaneous Phase 3 trials, but none met their primary endpoints, except for a subpopulation of uUTI patients with a quinolone non-susceptible pathogen.

Iterum Therapeutics: Delayed Review Of Its NDA For Sulopenem, But Upside Still Exists

Iterum is developing sulopenem for uncomplicated urinary tract infections.

Iterum: Failed Trials, Delayed NDAs, And Dilutions

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Iterum Therapeutics plc (NASDAQ: ITRM) shares dropped after the company in an SEC filing disclosed that the FDA needs additional time to review its sulopenem application.  The application seeks approval for sulopenem etzadroxil/probenecid for uncomplicated urinary tract infection.

Why Iterum (ITRM) Stock Is Plunging Today?

DUBLIN, Ireland and CHICAGO, April 06, 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 Corey Fishman, Chief Executive Officer, will provide a company overview and business update at the 20th Annual Needham Virtual Healthcare Conference on Thursday, April 15, at 3:45p.m. ET.

Iterum Therapeutics to Present at the 20th Annual Needham Virtual Healthcare Conference

The fact that other antibiotic makers have declared bankruptcy in recent years is a negative sign for Iterum. Long-term investors should avoid ITRM stock.

Iterum Therapeutics Stock Looks Like a High-Risk Name Here

Fundamentally, ITRM stock is an excellent play on multi-drug resistance pathogen solutions but you must also be aware of its extreme boom-bust cycles. The post Iterum Therapeutics' Science Won't Prevent Its Volatility appeared first on InvestorPlace.

Iterum Therapeutics' Science Won't Prevent Its Volatility

Iterum Therapeutics Appoints Beth P. Hecht to Board of Directors

The stock price of Iterum Therapeutics PLC (NASDAQ: ITRM) increased by 1.94% after hours on Friday. This is why it happened.

ITRM Stock Price Increased 1.94% After Hours: Why It Happened

Iterum Therapeutics plc (ITRM) CEO Corey Fishman on Q4 2020 Results - Earnings Call Transcript

The stock price of Iterum Therapeutics PLC (NASDAQ: ITRM) has increased by over 5% pre-market. This is why it happened.

ITRM Stock Price Increases Over 5% Pre-Market: Why It Happened

- -NDA for Oral Sulopenem has PDUFA date of July 25, 2021 --   - -Cash Runway into First Half of 2023 —

Iterum Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results

DUBLIN, Ireland and CHICAGO, March 05, 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 will release its fourth quarter and full year 2020 financial results before the open of the U.S. financial markets on Friday, March 12, 2021. Management will host a conference call at 8:30 a.m. ET that day to discuss the Company's financial and operational results.

Iterum Therapeutics to Announce Fourth Quarter and Full Year 2020 Financial Results and Host Conference Call on March 12, 2021

It's encouraging that Iterum's oral antibiotic has blockbuster status potential, but the basic earnings data on ITRM stock signal caution. The post Unfavorable Earnings Profile Doesn't Bode Well for Iterum Therapeutics Stock appeared first on InvestorPlace.

Unfavorable Earnings Profile Doesn't Bode Well for Iterum Therapeutics Stock

DUBLIN, Ireland and CHICAGO, Feb. 19, 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 Corey Fishman, Chief Executive Officer, will provide a company overview and business update at the following upcoming investor conferences:

Iterum Therapeutics to Present in Upcoming Investor Conferences

After three missed endpoints in three pivotal trials, Iterum's antibiotic treatment Sulopenem displayed superiority over standard-of-care Cipro in uUTI patients with quinolone resistant pathogens. Iterum has submitted its NDA to the FDA, which has been accepted for priority review, with a decision date set for late July.

Iterum Therapeutics: Sulopenem Approval Decision In July Is Make Or Break

The stock price of Iterum Therapeutics PLC (NASDAQ: ITRM) is trading at over 15% pre-market. This is why it happened.

ITRM Stock Price Increases Over 15% Pre-Market: Why It Happened

DUBLIN, Ireland and CHICAGO, Feb. 10, 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 underwriter of its previously announced underwritten public offering of ordinary shares, which closed on February 8, 2021, has exercised in full its option to purchase additional ordinary shares at the public offering price, less underwriting discounts and commissions. After giving effect to the sale of 5,217,391 additional ordinary shares in the option closing, the total number of ordinary shares sold by the Company in the offering increased to 40,000,000 shares, which resulted in aggregate net proceeds of approximately $42.1 million after deducting underwriting discounts and commissions and estimated offering expenses.

Iterum Therapeutics plc Announces Exercise of Underwriter's Option to Purchase Additional Ordinary Shares

DUBLIN, Ireland and CHICAGO, Feb. 09, 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 has entered into definitive agreements with several healthcare-focused institutional investors for the purchase and sale of 17,500,000 of its ordinary shares at a purchase price of $2.00 per ordinary share in a registered direct offering priced at-the-market under Nasdaq rules. The offering is expected to close on or about February 12, 2021, subject to the satisfaction of customary closing conditions.

Iterum Therapeutics plc Announces $35.0 Million Registered Direct Offering of Ordinary Shares Priced At-the-Market under Nasdaq Rules

Iterum Therapeutics (ITRM) stock is taking off on Tuesday with heavy trading even without any news coming from the company. The post ITRM Stock: 7 Things for Investors to Know About Iterum Therapeutics as Shares Surge appeared first on InvestorPlace.

ITRM Stock: 7 Things for Investors to Know About Iterum Therapeutics as Shares Surge

The stock price of Iterum Therapeutics PLC (NASDAQ: ITRM) is trading at over 60% pre-market today as of 5:50 AM ET. This is why it happened.

ITRM Stock Price Increases Over 60% Pre-Market

DUBLIN, Ireland and CHICAGO, Feb. 03, 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, due to demand, the underwriter has agreed to increase the size of the previously announced offering and purchase on a firm commitment basis 34,782,609 ordinary shares (or pre-funded warrants in lieu thereof) at a public offering price of $1.15 per share, less underwriting discounts and commissions. In addition, the Company has granted the underwriter an option for a period of 30 days to purchase up to an additional 5,217,391 ordinary shares on the same terms and conditions. All of the shares (or pre-funded warrants) are being offered by the Company. The offering is expected to close on or about February 8, 2021, subject to the satisfaction of customary closing conditions.

News for Iterum Therapeutics Plc Stock (ITRM)