Penem

Iterum Therapeutics announces Issuance of Allowance for a U.S. Patent Covering Oral Sulopenem

Retrieved on: 
Thursday, December 15, 2022
Hand, IV, China International Search and Rescue Team, Clinical trial, Probenecid, Penem, Security (finance), Bacteria, Food, FDA, Public policy, Patent, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, QIDP, Legislation, Urinary tract infection, ITRM, Infection, Therapy, COVID-19, Pharmaceutical industry

If approved, oral sulopenem will be the first oral penem available in the United States,” said Corey Fishman, Chief Executive Officer.

Key Points: 
  • If approved, oral sulopenem will be the first oral penem available in the United States,” said Corey Fishman, Chief Executive Officer.
  • The recently issued U.S. patent for oral sulopenem entitled “Combinations of Beta-Lactam Compounds and Probenecid and Uses Thereof” also expires in 2039, absent any extensions.
  • 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 Third Quarter 2022 Financial Results

Retrieved on: 
Thursday, November 10, 2022
Adult, Probenecid, Therapy, Senior, SPA, Security (finance), Compliance, Urinary tract infection, CRL, IV, Forward-looking statement, Exchangeable, United States Patent and Trademark Office, Patent, Food, Hand, BID, SEC, Compte rendu, Public policy, Penem, U.S. Securities and Exchange Commission, Research, GAAP, Patient, Note, COVID-19, Phrase, Nasdaq, FDA Special Protocol Assessment, Legislation, Regulation of tobacco by the U.S. Food and Drug Administration, ITRM, Finance Secretary (India), Clinical trial, Renewable Energy Derivative, Bacteria, Woman, Infection, Table, NDA, FDA, Income, GLOBE, Intellectual property, Investment, Maturity, China International Search and Rescue Team, Pharmaceutical industry, Bank

DUBLIN, Ireland and CHICAGO, Nov. 10, 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 third quarter ended September 30, 2022.

Key Points: 
  • DUBLIN, Ireland and CHICAGO, Nov. 10, 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 third quarter ended September 30, 2022.
  • U.S. Patent Issued Extending Protection: The United States Patent and Trademark Office (USPTO) has issued Iterum a new patent, No.
  • Research and development (R&D) expenses for the third quarter of 2022 were $4.4 million compared to $1.8 million for the same period in 2021.
  • General and administrative (G&A) expenses for the third quarter of 2022 were $2.7 million compared to $3.0 million for the same period in 2021.

Iterum Therapeutics to Provide Business Update and Report Third Quarter 2022 Financial Results on November 10, 2022

Retrieved on: 
Thursday, November 3, 2022
Company, IV, Infection, GLOBE, Investor, Penem, Therapy, QIDP, Nasdaq, Access, Bacteria, ITRM, 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 819977.
  • 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 Announces First Patient Dosed in REASSURE, a Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections

Retrieved on: 
Thursday, October 20, 2022
CRL, U.S. Securities and Exchange Commission, SPA, Urinary tract infection, SEC, Therapy, Woman, Hand, Infection, QIDP, Amoxicillin/clavulanic acid, NDA, Probenecid, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Penem, IV, Renewable Energy and Energy Efficiency Partnership, Security (finance), UTI, Nasdaq, Food, Legislation, Adult, Safety, Bacteria, Phrase, ITRM, GLOBE, Medical microbiology, Clinical trial, Forward-looking statement, Public policy, FDA, COVID-19, Pharmaceutical industry, Vaccine

DUBLIN, Ireland and CHICAGO, Oct. 20, 2022 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company developing antibiotics to treat infections caused by multi-drug resistant pathogens, today announced that the first patient has been dosed in its Phase 3 clinical trial, known as REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales (REASSURE), comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin® (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTI).

Key Points: 
  • With positive results, we would resubmit our new drug application (NDA) to the FDA in the second half of 2024.
  • The REASSURE trial is designed as a non-inferiority trial comparing oral sulopenem and Augmentin in the Augmentin susceptible population and is entitled A prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem etzadroxil/probenecid versus oral amoxicillin/clavulanate for treatment of uncomplicated urinary tract infections (uUTI) in adult women.
  • Patients will be randomized to receive either oral sulopenem twice daily for 5 days or Augmentin twice daily for 5 days.
  • The primary endpoint is the overall response (clinical and microbiologic combined response) at Day 12 of the trial.

Iterum Therapeutics to Present Data at IDWeek 2022

Retrieved on: 
Monday, October 17, 2022
Therapy, Infection, QIDP, Poster, Walter E. Washington Convention Center, Penem, IV, Nasdaq, Company, Walter, Bacteria, Infectious Diseases Society of America, ITRM, GLOBE, Washington Convention Center, Pharmaceutical industry

The hybrid conference will be held from October 19-23 at the Walter E. Washington Convention Center in Washington, D.C.

Key Points: 
  • The hybrid conference will be held from October 19-23 at the Walter E. Washington Convention Center in Washington, D.C.
  • Posters will be available for registrants on the IDWeek Interactive Program and the IDWeek Mobile App starting on October 19, 8 a.m.
  • 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 announces Issuance of Allowance for a U.S. Patent Covering Oral Sulopenem

Retrieved on: 
Monday, September 19, 2022
Penem, Infection, IV, COVID-19, China International Search and Rescue Team, FDA, Food, ITRM, Legislation, Company, Public policy, Therapy, U.S. Securities and Exchange Commission, Hand, Forward-looking statement, Clinical trial, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Phrase, Probenecid, United States Patent and Trademark Office, QIDP, Bacteria, Nasdaq, Patent, Urinary tract infection, Security (finance), GLOBE, SEC, Pharmaceutical industry

This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a U.S. patent after administrative processes are completed.

Key Points: 
  • This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a U.S. patent after administrative processes are completed.
  • Existing patent protection for sulopenem etzadroxil is scheduled to expire in 2029, subject to potential extension.
  • 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 to Present at the H.C. Wainwright 24th Annual Global Investment Conference

Retrieved on: 
Wednesday, September 7, 2022
ITRM, Therapy, IV, QIDP, Infection, GLOBE, Conference, Nasdaq, Company, Penem, Bacteria, Pharmaceutical industry

Management will also host investor meetings on September 13-14, 2022.

Key Points: 
  • Management will also host investor meetings on September 13-14, 2022.
  • 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.
  • Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics.
  • 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 Regains Compliance with Nasdaq Bid Price Rule

Retrieved on: 
Thursday, September 1, 2022
ITRM, Nasdaq, Therapy, IV, Calendar, QIDP, Letter, Infection, GLOBE, Company, Compliance, Penem, BID, Bacteria, Pharmaceutical industry

Consequently, Iterum Therapeutics is now in compliance with all applicable listing standards and its ordinary shares will continue to be listed on The Nasdaq Capital Market.

Key Points: 
  • Consequently, Iterum Therapeutics is now in compliance with all applicable listing standards and its ordinary shares will continue to be listed on The Nasdaq Capital Market.
  • The Company was previously notified in September 2021 that it was not in compliance with the Bid Price Rule because its ordinary shares failed to meet the closing bid price of$1.00or more for 30 consecutive business days.
  • Subsequently, the Company was granted a second 180-calendar day period, or until September 5, 2022, in which to regain compliance with the Bid Price Rule.
  • To regain compliance with the Bid Price Rule, the Company was required to maintain a minimum closing bid price of$1.00or more for at least 10 consecutive trading days.

Iterum Therapeutics Announces Date of 1-for-15 Reverse Share Split

Retrieved on: 
Wednesday, August 17, 2022
BID, U.S. Securities and Exchange Commission, Hand, Exercise, Computershare, Forward-looking statement, CUSIP, Legislation, GLOBE, Senior, Phrase, IV, SEC, Clinical trial, ITRM, Board, Security (finance), Annual report, Nasdaq, Annual, Therapy, COVID-19, Company, QIDP, Bacteria, Infection, Public policy, Penem, Pharmaceutical industry

The Companys Board of Directors subsequently determined that the reverse share split was necessary for the Company to comply with the Bid Price Rule.

Key Points: 
  • The Companys Board of Directors subsequently determined that the reverse share split was necessary for the Company to comply with the Bid Price Rule.
  • No fractional ordinary shares will be issued in connection with the reverse share split.
  • The Companystransfer agent, Computershare, which is also acting as the exchange agent for the reverse share split, will provide instructions to shareholders regarding the process for exchanging physical share certificates.
  • Shareholders holding their ordinary shares in book-entry form or in brokerage accounts need not take any action in connection with the reverse share split.

Iterum Therapeutics Reports Second Quarter 2022 Financial Results

Retrieved on: 
Friday, August 12, 2022
FDA, Regulation of tobacco by the U.S. Food and Drug Administration, U.S. Securities and Exchange Commission, Hand, NDA, Table, Forward-looking statement, Legislation, GLOBE, Urinary tract infection, Phrase, IV, Senior, Maturity, Finance Secretary (India), SEC, Investment, CRL, Clinical trial, ITRM, Exchangeable, Security (finance), Nasdaq, Income, Therapy, COVID-19, Corporation, QIDP, Bacteria, SPA, Infection, G&A, GAAP, Research, Conference, Public policy, Note, Food, Penem, Pharmaceutical industry, Bank

DUBLIN, Ireland and CHICAGO, Aug. 12, 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 second quarter ended June 30, 2022.

Key Points: 
  • DUBLIN, Ireland and CHICAGO, Aug. 12, 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 second quarter ended June 30, 2022.
  • Research and development (R&D) expenses for the second quarter of 2022 were $4.0 million compared to $2.7 million for the same period in 2021.
  • General and administrative (G&A) expenses for the second quarter of 2022 were $4.1 million compared to $4.3 million for the same period in 2021.
  • Net loss for the second quarter of 2022 was $6.7 million compared to net income of $7.8 million for the same period in 2021.