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[{"company":"Dicerna Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dicerna Receives Orphan Drug Designation From FDA for DCR-A1AT ","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Dicerna Pharmaceuticals"},{"company":"89bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"89bio Announces Closing of Enrollment in its Phase 1b\/2a NASH Trial ","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"89bio"},{"company":"89bio","sponsor":"BofA Securities","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"89bio Announces Proposed Public Offering of Common Stock","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"89bio"},{"company":"89bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"89bio to Announce Topline Results from Phase 1b\/2a Study of BIO89-100 in NASH","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"89bio"},{"company":"89bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"89bio To Present Data From Phase 1b\/2a Study of BIO89-100 In NASH at AASLD\u2019s The Liver Meeting\u00ae 2020","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"89bio"},{"company":"89bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"89bio Presents Updated Clinical Data from Positive Phase 1b\/2a Study of BIO89-100 in NASH at AASLD\u2019s The Liver Meeting\u00ae 2020","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"89bio"},{"company":"89bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"89bio Presents Additional Analysis of Phase 1b\/2a NASH Study at the Annual ENDO 2021 Conference","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"89bio"},{"company":"Cour Pharmaceuticals","sponsor":"Ironwood Pharmaceuticals","pharmaFlowCategory":"D","amount":"$495.0 million","upfrontCash":"$20.0 million","newsHeadline":"Ironwood Pharmaceuticals Expands Pipeline by Signing an Option Agreement to Acquire an Exclusive License with COUR Pharmaceuticals to Develop and Commercialize CNP-104 for the Treatment of Primary Biliary Cholangitis (PBC) in the U.S.","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Peptide","graph2":"Cour Pharmaceuticals"},{"company":"Cour Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"COUR Pharmaceuticals Receives FDA Fast Track Designation for CNP-104 for the Treatment of Primary Biliary Cholangitis","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Cour Pharmaceuticals"}]

Cour Pharmaceuticals

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COUR Pharmaceuticals Receives FDA Fast Track Designation for CNP-104 for the Treatment of Primary Biliary Cholangitis

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.

Lead Product(s): Nanoparticle Encapsulating PDC-E2

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CNP-104

Highest Development Status: Phase I/ Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 10, 2022

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Cour Pharmaceuticals

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Ironwood Pharmaceuticals Expands Pipeline by Signing an Option Agreement to Acquire an Exclusive License with COUR Pharmaceuticals to Develop and Commercialize CNP-104 for ...

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 Cholangitis.

Lead Product(s): Nanoparticle Encapsulating PDC-E2

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CNP-104

Highest Development Status: Phase I/ Phase II Product Type: Peptide

Partner/Sponsor/Collaborator: Ironwood Pharmaceuticals

Deal Size: $495.0 million Upfront Cash: $20.0 million

Deal Type: Acquisition November 04, 2021

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89bio

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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.

Lead Product(s): BIO89-100

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: BIO89-100

Highest Development Status: Phase I/ Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 20, 2021

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89bio

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89bio Presents Updated Clinical Data from Positive Phase 1b/2a Study of BIO89-100 in NASH at AASLD’s The Liver Meeting® 2020

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 the trial.

Lead Product(s): BIO89-100

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: BIO89-100

Highest Development Status: Phase I/ Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 13, 2020

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89bio

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89bio To Present Data From Phase 1b/2a Study of BIO89-100 In NASH at AASLD’s The Liver Meeting® 2020

Details:

Clinical data from its Phase 1b/2a study evaluating BIO89-100, a long-acting glycoPEGylated FGF21 analog, in patients with nonalcoholic steatohepatitis (NASH) will be presented in a late-breaking poster at The Liver Meeting Digital Experience™ 2020 of the AASLD.

Lead Product(s): BIO89-100

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: BIO89-100

Highest Development Status: Phase I/ Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 02, 2020

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89bio

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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.

Lead Product(s): BIO89-100

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: BIO89-100

Highest Development Status: Phase I/ Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 13, 2020

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89bio

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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 corporate purposes.

Lead Product(s): BIO89-100

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: BIO89-100

Highest Development Status: Phase I/ Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: BofA Securities

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Public Offering July 06, 2020

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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.

Lead Product(s): BIO89-100

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 13, 2020

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Dicerna Pharmaceuticals

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Dicerna Receives Orphan Drug Designation From FDA for DCR-A1AT

Details:

The Company expects to dose the first patient in the second half of 2020.

Lead Product(s): DCR-A1AT

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 18, 2020

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