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Find Clinical Drug Pipelines for Hepatology (Liver, Pancreatic, Gall Bladder)

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            Lead Product(s): PXL770

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

            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 25, 2020

            Details:

            PXL770 treatment was observed to improve cardio-renal disease and adrenoleukodystrophy (ALD) /adrenomyeloneuropathy (AMN) in animal models.

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            Lead Product(s): PXL770

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: JMP Securities LLC

            Deal Size: $19.4 million Upfront Cash: Undisclosed

            Deal Type: Public Offering May 25, 2020

            Details:

            The use of proceeds will enable the Company to accelerate the development plans for PXL770 and PXL065 for the treatment of NASH, to pursue development activities in other metabolic diseases and for general corporate purposes.

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            Lead Product(s): Obeticholic Acid

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

            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 May 22, 2020

            Details:

            U.S.FDA has notified Intercept that its advisory committee meeting (AdCom) relating to the company’s new drug application (NDA) for obeticholic acid (OCA) for the treatment of liver fibrosis due to nonalcoholic steatohepatitis (NASH) has been postponed.

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            Lead Product(s): Namodenoson

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

            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 21, 2020

            Details:

            Patent allowance follows compelling Phase II data showing Namodenoson resolved all cases of NASH after 12 weeks of treatment, and it reduced hepatic fibrosis and steatosis in NAFLD and NASH patients.

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            Lead Product(s): CRV431

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 19, 2020

            Details:

            Hepion Pharmaceuticals has completed the submission of a Phase 1 data memo and the Phase 2a protocol to the FDA, and intends to commence its Phase 2a clinical trial of CRV431 for the treatment of NASH fibrosis in June.

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            Lead Product(s): Namodenoson

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

            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 18, 2020

            Details:

            All cases of NASH significantly resolved after 12 weeks of treatment with Namodenoson 25 mg.

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            Lead Product(s): Testosterone Undecanoate

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

            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 15, 2020

            Details:

            Clinical data for lead candidate TLANDO™ will be presented at the American Urological Association Virtual Conference. TLANDO is an oral testosterone replacement therapy product candidate for adult males with hypogonadism.

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            Lead Product(s): ASC41

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

            Highest Development Status: IND Enabling Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 13, 2020

            Details:

            Ascletis Pharma received IND approval from China's National Medical Products Administration (NMPA) for its in-house developed Category 1 Drug ASC41 to conduct clinical trials for Non-alcoholic Steatohepatitis (NASH) indication.

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            Lead Product(s): LPCN 1144

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

            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 13, 2020

            Details:

            The pharmacological effect of LPCN 1144 was investigated in a non-genomic, five arm, 12-week high fat diet ("HFD")-induced, rabbit animal model of NASH and hepatic fibrosis.

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            Lead Product(s): Elafibranor

            Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder)

            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 May 11, 2020

            Details:

            Elafibranor did not demonstrate a statistically significant effect on the primary endpoint of NASH resolution without worsening of fibrosis.

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