Ireland

Iterum Therapeutics

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Iterum Therapeutics Announces Topline Results from its Phase 3 Clinical Trial of Oral Sulopenem

Lead Product(s): Sulopenem Etzadroxil,Probenecid

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 29, 2020

Details:

In the population of patients with baseline pathogens resistant to quinolones, sulopenem achieved the related primary endpoint by demonstrating superiority to ciprofloxacin, providing substantial evidence of a treatment effect in patients with uUTI.

Nabriva Therapeutics

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Nabriva Therapeutics Receives Complete Response Letter from FDA on NDA for CONTEPO™ (fosfomycin) for injection

Lead Product(s): Fosfomycin Sodium

Therapeutic Area: Infections and Infectious Diseases Product Name: Contepo

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 19, 2020

Details:

Nabriva received a Complete Response Letter from the U.S. FDA for the New Drug Application NDA resubmission seeking marketing approval of CONTEPO for injection for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.

Iterum Therapeutics

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Iterum Therapeutics Announces $5 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules

Lead Product(s): Sulopenem

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: H.C. Wainwright & Co

Deal Size: $5.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering June 03, 2020

Details:

The Company intends to use the net proceeds to fund the continued clinical development of sulopenem, including the Company’s ongoing Phase 3 clinical trial of sulopenem for uUTI, the management of potential regulatory filings and for general corporate purposes.

Iterum Therapeutics

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Iterum's Future Looks Uncertain, After Lead Antibiotic Fails Consecutive Pivotal Studies

Lead Product(s): Sulopenem,Probenecid

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 01, 2020

Details:

Sulopenem did not achieve statistical non-inferiority relative to ertapenem in its SUlopenem for Resistant Enterobacteriaceae (SURE) 2 clinical trial in complicated urinary tract infection (cUTI).

Iterum Therapeutics

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Iterum Therapeutics Provides Update on Phase 3 Clinical Trials of Sulopenem

Lead Product(s): Sulopenem,Probenecid

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 31, 2020

Details:

Company anticipates reporting results from its Sulopenem for Resistant Enterobacteriaceae (SURE) 1 clinical trial in uUTI and SURE 2 clinical trial in cUTI in early part of the 2nd quarter of 2020.

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Companies

Iterum Therapeutics

Iterum Therapeutics Announces Topline Results from its Phase 3 Clinical Trial of Oral Sulopenem

Nabriva Therapeutics

Nabriva Therapeutics Receives Complete Response Letter from FDA on NDA for CONTEPO™ (fosfomycin) for injection

Iterum Therapeutics

Iterum Therapeutics Announces $5 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules

Iterum Therapeutics

Iterum's Future Looks Uncertain, After Lead Antibiotic Fails Consecutive Pivotal Studies

Iterum Therapeutics

Iterum Therapeutics Provides Update on Phase 3 Clinical Trials of Sulopenem