Lead Product(s) : CNP-104
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
COUR Receives Orphan Designation for CNP-104 in Primary Biliary Cholangitis
Details : CNP-104 is a biodegradable nanoparticle encapsulating the E2 component of the mitochondrial pyruvate dehydrogenase complex (PDC), a key autoantigen in PBC.
Product Name : CNP-104
Product Type : Enzyme
Upfront Cash : Inapplicable
January 08, 2025
Lead Product(s) : CNP-104
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : CNP-104
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
COUR Pharmaceuticals Reports Positive Results from Phase 2a Study of CNP-104
Details : CNP-104 is a biodegradable nanoparticle encapsulating the E2 component of the mitochondrial pyruvate dehydrogenase complex. It is being evaluated for primary biliary cholangitis.
Product Name : CNP-104
Product Type : Enzyme
Upfront Cash : Inapplicable
September 30, 2024
Lead Product(s) : CNP-104
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Nalmefene Hydrochloride
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase I/ Phase II
Sponsor : Hillstream BioPharma
Deal Size : Undisclosed
Deal Type : Agreement
Details : Through the agreement, Hillstream aims to acquire a clinical stage asset, AV104 (nalmefene), an opioid antagonist, but first it intends to seek approval in an orphan disease for the treatment of moderate to severe cholestatic pruritis with primary biliar...
Product Name : AV104
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
November 09, 2023
Lead Product(s) : Nalmefene Hydrochloride
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase I/ Phase II
Sponsor : Hillstream BioPharma
Deal Size : Undisclosed
Deal Type : Agreement
Lead Product(s) : CNP-104
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : CNP-104 uses COUR's proprietary nanoparticle platform (CNP), a novel system which combines disease specific pathogenic antigens with state-of-the-art pharmaceutical nanoparticles that mimic normal removal of dead or dying liver cells from the body.
Product Name : CNP-104
Product Type : Enzyme
Upfront Cash : Inapplicable
October 01, 2022
Lead Product(s) : CNP-104
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : CNP-104
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase I/ Phase II
Sponsor : Ironwood Pharmaceuticals
Deal Size : $495.0 million
Deal Type : Acquisition
Details : This agreement gives Ironwood an option to acquire an exclusive license to develop and commercialize, in the U.S., COUR’s investigational therapy CNP-104 (the “License”), which if successful, could transform the treatment of Primary Biliary Cholang...
Product Name : CNP-104
Product Type : Enzyme
Upfront Cash : $20.0 million
April 11, 2021
Lead Product(s) : CNP-104
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase I/ Phase II
Sponsor : Ironwood Pharmaceuticals
Deal Size : $495.0 million
Deal Type : Acquisition
Lead Product(s) : Pegozafermin
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
89bio Presents Additional Analysis of Phase 1b/2a NASH Study at the Annual ENDO 2021 Conference
Details : New analyses of the Phase 1b/2a study data showed BIO89-100 treatment resulted in significant reductions in liver volume of up to 15% and liver fat volume of up to 65% in treated patients at 13 weeks compared to baseline, as measured by MRI-PDFF.
Product Name : BIO89-100
Product Type : Protein
Upfront Cash : Inapplicable
March 20, 2021
Lead Product(s) : Pegozafermin
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegozafermin
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Similar reductions in liver fat, ALT and triglycerides between biopsy-confirmed NASH and PNASH patients treated with BIO89-100 and their similar baseline characteristics underscored the consistency across these two sub-populations of patients enrolled in...
Product Name : BIO89-100
Product Type : Protein
Upfront Cash : Inapplicable
November 13, 2020
Lead Product(s) : Pegozafermin
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegozafermin
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
89bio to Announce Topline Results from Phase 1b/2a Study of BIO89-100 in NASH
Details : Company plans to share topline safety, tolerability and efficacy data from its Phase 1b/2a study of BIO89-100 in NASH in a pre-market press release and webcast.
Product Name : BIO89-100
Product Type : Protein
Upfront Cash : Inapplicable
September 13, 2020
Lead Product(s) : Pegozafermin
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegozafermin
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase I/ Phase II
Sponsor : BofA Securities
Deal Size : Undisclosed
Deal Type : Public Offering
89bio Announces Proposed Public Offering of Common Stock
Details : 89bio intends to use the net proceeds of the offering to accelerate and support its BIO89-100 programs in nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG), for the manufacture and scale up of BIO89-100, and for other general cor...
Product Name : BIO89-100
Product Type : Protein
Upfront Cash : Undisclosed
June 07, 2020
Lead Product(s) : Pegozafermin
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase I/ Phase II
Sponsor : BofA Securities
Deal Size : Undisclosed
Deal Type : Public Offering
Lead Product(s) : Pegozafermin
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
89bio Announces Closing of Enrollment in its Phase 1b/2a NASH Trial
Details : The company closed enrollment in its Phase 1b/2a NASH trial with 98% of patients enrolled and delays initiation of its SHTG trial due to the COVID-19 pandemic.
Product Name : BIO89-100
Product Type : Protein
Upfront Cash : Inapplicable
April 13, 2020
Lead Product(s) : Pegozafermin
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable