Penem

Iterum Therapeutics Announces Special Protocol Assessment (SPA) Agreement With the FDA

Retrieved on: 
Monday, July 11, 2022
Safety, Penem, FDA, ITRM, COVID-19, Adult, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IV, U.S. Securities and Exchange Commission, Therapy, Annual report, NDA, Urinary tract infection, Public policy, Marketing, Food, Hand, Legislation, CRL, SPA, Medical microbiology, Company, Infection, Forward-looking statement, Bacteria, Nasdaq, Review, Phrase, GLOBE, Patient, SEC, QIDP, Security (finance), Clinical trial, Pharmaceutical industry

DUBLIN, Ireland and CHICAGO, July 11, 2022 (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, announced today that it has reached an agreement with the U.S. Food and Drug Administration (“FDA”) under the special protocol assessment (“SPA”) process on the design, endpoints and statistical analysis of a Phase 3 clinical trial for oral sulopenem etzadroxil-probenecid (“oral sulopenem”) for the treatment of uncomplicated urinary tract infections (“uUTI”). The SPA agreement provides that the design and planned analysis of the trial, as set out in the protocol submitted to the FDA, adequately addresses the objectives necessary to support the potential resubmission of the Company’s new drug application (“NDA") for oral sulopenem.

Key Points: 
  • We are excited about this important milestone and are looking forward to starting recruitment for this trial as soon as possible.
  • A SPA agreement indicates concurrence by the FDA with the adequacy and acceptability of specific critical elements of the overall protocol design for a clinical trial intended to support a future marketing application, but it does not indicate FDA concurrence on every protocol detail.
  • Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation.
  • Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Iterum Therapeutics Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Wednesday, July 6, 2022
GLOBE, Penem, Company, Employment, Bacteria, ITRM, Nasdaq, Infection, IV, QIDP, Therapy, Pharmaceutical industry

This grant wasawarded pursuant to the Nasdaq inducement grant exception as a component of new hire employment compensation.

Key Points: 
  • This grant wasawarded pursuant to the Nasdaq inducement grant exception as a component of new hire employment compensation.
  • The share option was granted effectiveJuly 5, 2022with an exercise price of$0.22per share, which is equal to the closing price of Iterum Therapeutics ordinary shares on the date of grant.
  • The share option was approved by the Companys Compensation Committee and was granted as an inducement material to the new employees acceptance of employment in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The share option is subject to the terms and conditions of a share option agreement covering the grant and the Companys 2021 Inducement Equity Incentive Plan.

Iterum Therapeutics Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Tuesday, June 14, 2022
ITRM, Infection, IV, Company, Penem, Bacteria, Nasdaq, QIDP, Employment, Therapy, GLOBE, Pharmaceutical industry

This grant wasawarded pursuant to the Nasdaq inducement grant exception as a component of new hire employment compensation.

Key Points: 
  • This grant wasawarded pursuant to the Nasdaq inducement grant exception as a component of new hire employment compensation.
  • The share option was granted effectiveJune 13, 2022with an exercise price of$0.21per share, which is equal to the closing price of Iterum Therapeutics ordinary shares on the date of grant.
  • The share option was approved by the Companys Compensation Committee and was granted as an inducement material to the new employees acceptance of employment in accordance with Nasdaq Listing Rule 5635(c)(4).
  • Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Iterum Therapeutics Reports First Quarter 2022 Financial Results

Retrieved on: 
Friday, May 13, 2022
Public policy, Senior, Penem, QIDP, R, Regulation of tobacco by the U.S. Food and Drug Administration, Infection, Food, Research, Maturity, U.S. Securities and Exchange Commission, Nasdaq, Woman, Investment, Bacteria, Note, Silicon, Exchangeable, Therapy, Treatment, Clinical trial, IV, COVID-19, Adult, Legislation, CRL, FDA, Silicon Valley Bank, SPA, Net, Uncomplicated Firewall, Finance Secretary (India), Conference, Forward-looking statement, NDA, Met, GAAP, Urinary tract infection, Corporation, ITRM, SEC, Community for Open Antimicrobial Drug Discovery, Phrase, GLOBE, Security (finance), Hand, Table, Pharmaceutical industry, Bank

DUBLIN, Ireland and CHICAGO, May 13, 2022 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (“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 reported financial results for the first quarter ended March 31, 2022.

Key Points: 
  • DUBLIN, Ireland and CHICAGO, May 13, 2022 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (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 reported financial results for the first quarter ended March 31, 2022.
  • As of April 30, 2022, Iterum had approximately 183.4 million ordinary shares outstanding.
  • Research and development (R&D) expenses for the first quarter of 2022 were $3.4 million compared to $2.5 million for the same period in 2021.
  • General and administrative (G&A) expenses for the first quarter of 2022 were $3.9 million compared to $3.4 million for the same period in 2021.

Iterum Therapeutics Provides Regulatory Update

Retrieved on: 
Wednesday, May 11, 2022
COVID-19, U.S. Securities and Exchange Commission, CRL, Forward-looking statement, QIDP, Nasdaq, Woman, SPA, GLOBE, NDA, Urinary tract infection, Food, Legislation, Hand, Security (finance), Infection, Clinical trial, FDA, Annual report, US Foods, ITRM, Adult, Phrase, Public policy, IV, SEC, Bacteria, Penem, Therapy, Pharmaceutical industry

Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world.

Key Points: 
  • Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world.
  • Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation.
  • Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.
  • Except as required by law, Iterum assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

Iterum Therapeutics Presented Data at the 32nd European Congress of Clinical Microbiology and Infectious Diseases

Retrieved on: 
Monday, April 25, 2022
Treatment, Phrase, Nasdaq, Organic acid, U.S. Securities and Exchange Commission, COVID-19, Security (finance), Metronidazole, Legislation, Annual report, Bacteria, Public policy, European, Infection, Penem, Complicated, GLOBE, ITRM, Safety, QIDP, Company, IV, Hand, SEC, Forward-looking statement, Therapy, Congress, Pharmaceutical industry

New or repurposed antibacterial agents: clinical trials

Key Points: 
  • New or repurposed antibacterial agents: clinical trials
    These Posters can be found on the Companys website on the Publications: Posters & Presentations page under the Our Science tab.
  • Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world.
  • Iterum is currently advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation.
  • Iterum has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Iterum Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results

Retrieved on: 
Monday, March 28, 2022
CRL, Therapy, Public policy, Finance Secretary (India), Investment, Forward-looking statement, Legislation, GAAP, Compliance, Bacteria, Silicon Valley Bank, ITRM, SEC, QIDP, Research, Conference, U.S. Securities and Exchange Commission, Urinary tract infection, Penem, Senior, Hand, G&A, Net, Maturity, Note, COVID-19, GLOBE, NDA, Phrase, Infection, R, Annual report, FDA, Exchangeable, Corporation, Table, Silicon, Security (finance), IV, Pharmaceutical industry, Lithium, Bank, Nasdaq

DUBLIN, Ireland and CHICAGO, March 28, 2022 (GLOBE NEWSWIRE) -- 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 fourth quarter and year ended December 31, 2021.

Key Points: 
  • The articles can be accessed under Scientific Publications in the Our Science section of the Companys website at www.iterumtx.com .
  • Research and development (R&D) expenses for the fourth quarter and full year 2021 were $3.7 million and $10.7 million, respectively, compared to $2.4 million and $21.1 million for thesame periods in 2020.
  • The increase for the three-month period was primarily due to the non-cash amortization of an intangible asset in 2021.
  • General and administrative (G&A) expenses for the fourth quarter and full year 2021 were $3.1 million and $13.8 million, respectively, compared to $2.3 million and $11.1 million for thesame periods in 2020.

Iterum Therapeutics to Provide Business Update and Report Fourth Quarter and Full Year 2021 Financial Results on March 28, 2022

Retrieved on: 
Monday, March 21, 2022
Company, Therapy, Public policy, Investor, Forward-looking statement, Legislation, Access, Bacteria, ITRM, SEC, QIDP, Nasdaq, U.S. Securities and Exchange Commission, Penem, Hand, COVID-19, GLOBE, Phrase, Infection, Security (finance), IV, Pharmaceutical industry

Management will host a conference call at8:30 a.m. ETthat day to discuss the Companys financial results and provide an update on its business.

Key Points: 
  • Management will host a conference call at8:30 a.m. ETthat day to discuss the Companys financial results and provide an update on its business.
  • To access the call please dial 844-200-6205 (domestic) or 929-526-1599 (international) and refer to Access Code 096194.
  • The audio webcast can be accessed under Financials & Filings in the Investors section of the Companys website at www.iterumtx.com following the call.
  • Iterum is currently advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation.

Iterum Therapeutics Granted 180-Day Extension by Nasdaq to Regain Compliance with Bid Price Rule

Retrieved on: 
Thursday, March 10, 2022
Penem, Compliance, Company, U.S. Securities and Exchange Commission, Regulation of tobacco by the U.S. Food and Drug Administration, Phrase, LLC, IV, BID, Public policy, QIDP, ITRM, Hand, Intention, GLOBE, Calendar, Security (finance), COVID-19, Therapy, Infection, SEC, Food, Legislation, Forward-looking statement, Bacteria, Pharmaceutical industry, Nasdaq

If at any time prior to September 5, 2022, the bid price of the Company's ordinary shares closes at$1.00per share or more for a minimum of 10 consecutive business days, the Company will regain compliance with the Bid Price Rule, and the matter will be closed.

Key Points: 
  • If at any time prior to September 5, 2022, the bid price of the Company's ordinary shares closes at$1.00per share or more for a minimum of 10 consecutive business days, the Company will regain compliance with the Bid Price Rule, and the matter will be closed.
  • If the Company does not regain compliance with the Bid Price Rule during the additional 180-day extension, Nasdaq will provide written notification to the Company that its ordinary shares will be delisted.
  • Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation.
  • Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Iterum Therapeutics Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Tuesday, February 8, 2022
GLOBE, Employment, Penem, Company, Infection, Therapy, Bacteria, IV, QIDP, ITRM, Nasdaq, Pharmaceutical industry

This grant wasawarded pursuant to the Nasdaq inducement grant exception as a component of new hire employment compensation.

Key Points: 
  • This grant wasawarded pursuant to the Nasdaq inducement grant exception as a component of new hire employment compensation.
  • The share option was granted effectiveFebruary 4, 2022with an exercise price of$0.41per share, which is equal to the closing price of Iterum Therapeutics ordinary shares on the date of grant.
  • The share option was approved by the Companys Compensation Committee and was granted as an inducement material to the new employees acceptance of employment in accordance with Nasdaq Listing Rule 5635(c)(4).
  • Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.