Iterum Therapeutics

79 articles with Iterum Therapeutics

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  Three Pharma Companies Seek to Address FDA Rejections

  11/17/2021

  Iterum Therapeutics will head back into the clinic to meet regulatory requirements to refile a New Drug Application for oral sulopenem.

• Iterum Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Update

  11/12/2021

  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, reported financial results for the third quarter ended September 30, 2021.

• Iterum Therapeutics to Provide Business Update and Report Third Quarter 2021 Financial Results on November 12, 2021

  11/5/2021

  Iterum Therapeutics plc today announced that the Company will release its third quarter 2021 financial results before the open of the U.S. financial markets on Friday, November 12, 2021.

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  Global Roundup: Partnership Aims to Bolster Drug Discovery in Africa

  9/30/2021

  Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.

• Iterum Therapeutics to Present Data at IDWeek 2021

  9/28/2021

  Iterum Therapeutics plc today announced a data presentation at the Infectious Disease Society of America (IDSA) IDWeek TM 2021, taking place virtually from September 29 – October 3, 2021.

• Iterum Therapeutics Provides Update from FDA Type A Meeting Regarding Oral Sulopenem

  9/28/2021

  Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), today announced that the Company held a Type A meeting with the U.S. Food and Drug Administration (FDA) during the third quarter of 2021 to discuss the steps required for potential resubmission of the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem).

• Iterum Therapeutics to Present at the H.C. Wainwright 23rd Annual Global Investment Conference

  9/8/2021

  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 H.C. Wainwright 23rd Annual Virtual Global Investment Conference.

• Iterum Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Update

  8/13/2021

  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, reported financial results for the second quarter ended June 30, 2021.

• Iterum Therapeutics to Provide Business Update and Report Second Quarter 2021 Financial Results on August 13, 2021

  8/6/2021

  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 the Company will release its second quarter 2021 financial results before the open of the U.S. financial markets on Friday, August 13, 2021.

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  FDA Action Alert: Incyte, Iterum and Ardelyx

  7/26/2021

  The U.S. Food and Drug Administration (FDA) had several PDUFA dates on their calendar for the last week of July, but in two cases, there were problems with the submissions ahead of time. Here’s a look.

• 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