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Lead Product(s): Sulopenem Etzadroxil
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: $17.5 million Upfront Cash: Undisclosed
Deal Type: Public Offering October 23, 2020
Details:
The Company intends to use the net proceeds from this offering to support its planned NDA submission for oral sulopenem for the treatment of uncomplicated urinary tract infections in patients with quinolone-resistant pathogens, the continued clinical development of sulopenem.
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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 October 19, 2020
Details:
The two data presentations will include a poster presentation of the results of SURE-2 in complicated urinary tract infections (cUTI) as well as a late breaker oral abstract presentation of the results from SURE-1 in uncomplicated urinary tract infections (uUTI).
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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.
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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.
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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.
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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).
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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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