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[{"company":"Galectin Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Galectin Therapeutics Submits Seamless Adaptively-Designed Phase 2b\/3 NASH-RX Protocol in NASH Cirrhosis","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"GEORGIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Galectin Therapeutics"},{"company":"Galectin Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Galectin Therapeutics Announces Commencement of Patient Enrollment of the Adaptively-Designed Phase 2b\/3 Trial of Belapectin","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"GEORGIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Galectin Therapeutics"},{"company":"Galectin Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Galectin Therapeutics to Present at 4th Global NASH Congress","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"GEORGIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Galectin Therapeutics"},{"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Calliditas Receives FDA Fast Track Designation for Setanaxib in PBC","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Calliditas Therapeutics AB"},{"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"US FDA Grants Fast Track Status to Calliditas\u2019 Setanaxib for PBC","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Calliditas Therapeutics AB"},{"company":"Galectin Therapeutics","sponsor":"Richard E. Uihlein","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Galectin Therapeutics Announces $20 Million Convertible Debt Financing from Its Chairman, Richard E. Uihlein","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"GEORGIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Galectin Therapeutics"},{"company":"Galectin Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Galectin Pharmaceuticals to Present Six Scientific Abstracts at The Liver Meeting\u2122 2021, Hosted by the AASLD","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"GEORGIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Galectin Therapeutics"},{"company":"Zydus Cadila","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zydus Announces EPICS-IIITM Phase 2(b)\/3 Adaptive Pivotal Clinical Trial of Saroglitazar Mg in PBC","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Zydus Cadila"},{"company":"Calliditas Therapeutics AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Patient Randomized in Pivotal TRANSFORM Study with Setanaxib","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Calliditas Therapeutics AB"},{"company":"Galectin Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Galectin Therapeutics Reports the Positive Outcome of the First Data and Safety Monitoring Board for NAVIGATE, its Seamless, Adaptive Phase 2b\/3 Study of Belapectin in Patients with Liver Cirrhosis Caused by Non-Alcoholic Steatohepatitis","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"GEORGIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Galectin Therapeutics"}]

Galectin Therapeutics

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Galectin Therapeutics Reports the Positive Outcome of the First Data and Safety Monitoring Board for NAVIGATE, its Seamless, Adaptive Phase 2b/3 Study of Belapectin in Pati...

Details:

Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis.

Lead Product(s): Belapectin

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GR-MD-02

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 14, 2022

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Calliditas Therapeutics AB

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First Patient Randomized in Pivotal TRANSFORM Study with Setanaxib

Details:

The TRANSFORM Phase 2b/3 trial for GKT831 (setanaxib), a NOX1 and NOX4 inhibitor, will investigate the effect of setanaxib versus placebo on alkaline phosphatase reduction in patients with PBC also has shown evidence of anti-fibrotic activity in a Phase II clinical trial.

Lead Product(s): Setanaxib

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GKT831

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 15, 2022

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Zydus Cadila

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Zydus Announces EPICS-IIITM Phase 2(b)/3 Adaptive Pivotal Clinical Trial of Saroglitazar Mg in PBC

Details:

Company announced that it has received permission from the USFDA to initiate the Phase 2(b)/3 clinical trial to evaluate efficacy and safety of Lipaglyn (Saroglitazar Magnesium) in subjects with PBC.

Lead Product(s): Saroglitazar magnesium

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

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 10, 2021

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Galectin Therapeutics

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Galectin Pharmaceuticals to Present Six Scientific Abstracts at The Liver Meeting™ 2021, Hosted by the AASLD

Details:

Galectin-3, a glycan binding protein, plays a central role to foster liver inflammation and fibrosis in NASH cirrhosis. Belapectin is a galectin-3 inhibitor in development for NASH cirrhosis.

Lead Product(s): Belapectin

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GR-MD-02

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 05, 2021

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Galectin Therapeutics

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Galectin Therapeutics Announces $20 Million Convertible Debt Financing from Its Chairman, Richard E. Uihlein

Details:

The financing will support the progress of belapectin in NAVIGATE trial for patients with NASH cirrhosis and exploring in combination for the treatment of metastatic melanoma.

Lead Product(s): Belapectin

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GR-MD-02

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Richard E. Uihlein

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Financing September 21, 2021

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Calliditas Therapeutics AB

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Calliditas Receives FDA Fast Track Designation for Setanaxib in PBC

Details:

Following positive results from a Phase 1 study conducted in 2020 which evaluated higher doses of setanaxib in healthy volunteers, Calliditas is planning to initiate a pivotal Phase 2/3 study in PBC.

Lead Product(s): Setanaxib

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GKT137831

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 09, 2021

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Calliditas Therapeutics AB

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US FDA Grants Fast Track Status to Calliditas’ Setanaxib for PBC

Details:

In a Phase 2 clinical trial, setanaxib demonstrated evidence of anti-fibrotic activity as measured by Fibroscan, combined with a favorable tolerability profile, as well as a statistically significant impact on fatigue.

Lead Product(s): Setanaxib

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GKT831

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 09, 2021

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Galectin Therapeutics

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Galectin Therapeutics to Present at 4th Global NASH Congress

Details:

Company will present poster titled "An innovative clinical development program: belapectin for NASH cirrhosis". Belapectin is a proprietary galactoarabino-rhamnogalacturonan polysaccharide polymer, Gal-3 inhibitor for esophageal varices in patients with NASH cirrhosis.

Lead Product(s): Belapectin

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GR-MD-02

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 27, 2021

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Galectin Therapeutics

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Galectin Therapeutics Announces Commencement of Patient Enrollment of the Adaptively-Designed Phase 2b/3 Trial of Belapectin

Details:

Compelling NASH-RX trial result could potentially lead to accelerated FDA approval and/or partnership opportunities and fulfill an acute unmet medical need.

Lead Product(s): Belapectin

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: GR-MD-02

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 30, 2020

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Galectin Therapeutics

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Galectin Therapeutics Submits Seamless Adaptively-Designed Phase 2b/3 NASH-RX Protocol in NASH Cirrhosis

Details:

Phase 2b/3 clinical study will evaluate the safety and efficacy of galectin-3 inhibitor, belapectin, for the prevention of esophageal varices in patients with non-alcoholic steatohepatitis cirrhosis.

Lead Product(s): Belapectin

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

Highest Development Status: Phase II/ Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 30, 2020

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