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    [{"orgOrder":0,"company":"HighTide Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HighTide Therapeutics Announces Positive Topline Results From Phase 2a Study of HTD1801 in NASH Patients","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"HighTide Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HighTide Therapeutics to Present Phase 2 Results of HTD1801 in NASH Patients Co-Morbid with Type 2 Diabetes at NASH Summit","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase 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              HighTide Therapeutics

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              HighTide Therapeutics Raises $107 Million in Series C/C+ Financing to Advance Innovative Pipeline and Business Collaborations

              Details:

              HighTide's lead candidate HTD1801 (berberine ursodeoxycholate), is a novel multifunctional molecule, being developed for the treatment of patients suffering from complex metabolic and digestive diseases.

              Lead Product(s): Berberine Ursodeoxycholate

              Therapeutic Area: Endocrinology Product Name: HTD1801

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: TCM Healthcare

              Deal Size: $107.0 million Upfront Cash: Undisclosed

              Deal Type: Series C Financing January 05, 2023

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              HighTide Therapeutics and Quotient Sciences Announce Agreement to Conduct a 14C Human ADME Program for HTD1801

              Details:

              HTD1801 (berberine ursodeoxycholate), is a first-in-class new molecular entity, currently in Phase II trials for the treatment of primary sclerosing cholangitis (PSC), and nonalcoholic steatohepatitis (NASH).

              Lead Product(s): Berberine Ursodeoxycholate

              Therapeutic Area: Endocrinology Product Name: HTD1801

              Highest Development Status: Phase II Product Type: Small molecule

              Recipient: Quotient Sciences

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Agreement December 15, 2022

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              HighTide Therapeutics Announces Presentations at The Liver Meeting® 2022

              Details:

              The data showing positive changes in gut microbiota are encouraging and provide another mechanism of action underlying the beneficial effects of HTD1801 (Berberine Ursodeoxycholate) in liver and metabolic diseases.

              Lead Product(s): Berberine Ursodeoxycholate

              Therapeutic Area: Endocrinology Product Name: HTD1801

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 25, 2022

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              HighTide Therapeutics Announces Early Completion of Enrollment in Phase 2 Clinical Study Evaluating HTD1801 in Type 2 Diabetes Mellitus

              Details:

              The unique design of HTD1801 (berberine ursodeoxycholate) results in its pleiotropic therapeutic effects. Previous Phase 2 study in adults with comorbid nonalcoholic steatohepatitis (NASH) and T2DM completed in the United States demonstrated overall clinical benefits.

              Lead Product(s): Berberine Ursodeoxycholate

              Therapeutic Area: Endocrinology Product Name: HTD1801

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable August 30, 2022

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              HighTide Therapeutics Announces First Patient Dosed in Phase 2 Clinical Study Evaluating HTD1801 in Type 2 Diabetes Mellitus

              Details:

              HTD1801 is a first-in-class new molecular entity with pleiotropic effects, designed to target both the metabolic pathways critical to the development of T2DM and pathogenic factors underlying liver dysfunction and the progression of NAFLD.

              Lead Product(s): Berberine Ursodeoxycholate

              Therapeutic Area: Endocrinology Product Name: HTD1801

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 29, 2022

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              HighTide Therapeutics Announces End-of-Phase 2 Meeting with FDA and Agreement to Proceed to Phase 3 for HTD1801 for the Treatment of PSC

              Details:

              The company had a productive discussion with FDA as part of an End-of-Phase 2 meeting, regarding the key elements of the study design of HTD1801 in patients with PSC and will be submitting a Phase 3 protocol to FDA for review and comment.

              Lead Product(s): Berberine Ursodeoxycholate

              Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: HTD1801

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: U.S. Food and Drug Administration

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Agreement February 22, 2022

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              HighTide Therapeutics Announces End-of-Phase 2 Meeting with FDA and Agreement to Proceed to Phase 3 for HTD1801 for the Treatment of PSC

              Details:

              The company had a productive discussion with FDA as part of an End-of-Phase 2 meeting, regarding the key elements of the study design of HTD1801 in patients with PSC and will be submitting a Phase 3 protocol to FDA for review and comment.

              Lead Product(s): Berberine Ursodeoxycholate

              Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: HTD1801

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: U.S. Food and Drug Administration

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 22, 2022

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              HighTide Therapeutics to Present New PSC and NASH Clinical Data at AASLD 2021

              Details:

              An orally active ionic salt of berberine and ursodeoxycholic acid in development for chronic liver diseases, HTD1801 is currently being evaluated in Phase 2 trials in PSC, NASH and PBC.

              Lead Product(s): Berberine Ursodeoxycholate

              Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: HTD1801

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 28, 2021

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              HighTide Therapeutics to Present Phase 2 Results of HTD1801 in NASH Patients Co-Morbid with Type 2 Diabetes at NASH Summit

              Details:

              HighTide will show the results of their Phase 2 study of HTD1801 in adults with NASH and type 2 diabetes mellitus. HTD1801 met primary endpoint in Phase 2 trial with statistically significant reduction in liver fat in patients with NASH and diabetes.

              Lead Product(s): Berberine Ursodeoxycholate

              Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: HTD1801

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 15, 2020

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              HighTide Therapeutics Announces Positive Topline Results From Phase 2a Study of HTD1801 in NASH Patients

              Details:

              HTD1801 met primary endpoint in Phase 2 trial with statistically significant reduction in liver fat in patients with NASH and diabetes.

              Lead Product(s): HTD1801

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

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 07, 2020

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