Iterum Therapeutics

89 articles with Iterum Therapeutics

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

  7/26/2021

  Iterum Therapeutics plc, 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, announced that it received a Complete Response Letter from the U.S. Food and Drug Administration for its New Drug Application for sulopenem etzadroxil/probenecid on July 23, 2021.

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  Iterum Therapeutics Plunges Following FDA Rejection of Oral Sulopenem

  7/26/2021

  The FDA called for Iterum to conduct an additional clinical study that uses a different drug for comparison and to determine optimal dosing. 

• Iterum Therapeutics Provides Regulatory Update

  7/1/2021

  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 received a letter from the U.S. Food and Drug Administration

• Iterum Therapeutics Provides Update on NDA Review

  5/27/2021

  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.

• Iterum Therapeutics Reports First Quarter 2021 Financial Results

  5/14/2021

  Iterum Therapeutics plc (Nasdaq: ITRM), 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 reported financial results for the first quarter ended March 31, 2021.

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

  5/7/2021

  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.

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

  4/6/2021

  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 

• Iterum Therapeutics Appoints Beth P. Hecht to Board of Directors

  3/16/2021

  Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company” or “Iterum”), 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 the appointment of Beth P. Hecht to the Company’s Board of Directors replacing Patrick Heron

• Iterum Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results

  3/12/2021

  - -NDA for Oral Sulopenem has PDUFA date of July 25, 2021 --   - -Cash Runway into First Half of 2023 — --Company to host conference call today at 8:30amET--

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

  3/5/2021

  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

• Iterum Therapeutics to Present in Upcoming Investor Conferences

  2/19/2021

  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 plc Announces Exercise of Underwriter’s Option to Purchase Additional Ordinary Shares

  2/10/2021

  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,

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

  2/10/2021

  Iterum Therapeutics plc 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.

• Iterum Therapeutics plc Increases Previously Announced Bought Deal Public Offering of Ordinary Shares to $40.0 Million

  2/4/2021

  Iterum Therapeutics plc 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 at a public offering price of $1.15 per share, less underwriting discounts and commissions.

• Iterum Therapeutics plc Announces $10 Million Bought Deal Public Offering of Ordinary Shares

  2/3/2021

  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 an underwriting agreement with H.C. Wainwright & Co., LLC

• Iterum Therapeutics Announces Collaboration with EVERSANA to Support Oral Sulopenem Launch

  2/1/2021

  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 it has engaged EVERSANA™,

• Iterum Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Oral Sulopenem

  1/25/2021

  Iterum Therapeutics plc today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in patients with a quinolone non-susceptible pathogen.

• Iterum Therapeutics to Participate in H.C. Wainwright BioConnect Virtual Conference

  1/6/2021

  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 management will participate in the H.C. Wainwright BioConnect Conference being held virtually from January 11-14, 2021. Corey Fishman, Chief Executive Offic

• Iterum Therapeutics Announces Transition of Michael Dunne, M.D. to Strategic Advisor and Member of the Board of Directors

  12/23/2020

  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 Dr. Michael Dunne has resigned from his role as Chief Scientific Officer of the Company, effective December 21, 2020.

• Iterum Therapeutics Receives Approval to Transfer to Nasdaq Capital MarketTrading on Nasdaq Capital Market is expected to begin on December 23, 2020

  12/21/2020

  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 on December 18, 2020, the Listing Qualifications department of The Nasdaq Stock Market LLC (“Nasdaq”) approved the Company's request to transfer its listing