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Details:
Madrigal intends to use the net proceeds from this offering for its commercial activities in connection with the launch of Rezdiffra (resmetirom), a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of NASH, in the US.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Rezdiffra
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Goldman Sachs & Co. LLC
Deal Size: $600.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 18, 2024
Details:
Rezdiffra (resmetirom) is a once-daily, oral THR-β agonist designed to target key underlying causes of NASH. It is approved for the treatment of patients with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Rezdiffra
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 14, 2024
Details:
MGL-3196 (Resmetirom) is a once-daily, oral, liver-directed THR-β agonist , which is being evaluated for the treatment of NASH/MASH with Liver Fibrosis.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 05, 2024
Details:
Madrigal will use the proceeds for its clinical and commercial activities in preparation for a potential launch of MGL-3196 (resmetirom), a once daily, oral, thyroid hormone receptor-beta selective agonist designed to target key underlying causes of NASH in the liver.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Goldman Sachs & Co. LLC
Deal Size: $500.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering September 28, 2023
Details:
MGL-3196 (resmetirom) is a once daily, oral, thyroid hormone receptor (THR)-beta selective agonist designed to target key underlying causes of NASH in the liver.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2023
Details:
MGL-3196 (resmetirom), is a once daily, oral, liver-directed selective thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 17, 2023
Details:
MGL-3196 (resmetirom), is a once daily, oral, liver-directed selective thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 18, 2023
Details:
MGL-3196 (resmetirom), is a once daily, oral, liver-directed selective thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 06, 2023
Details:
MGL-3196 (resmetirom) is a liver-directed, orally active, selective thyroid hormone receptor-β agonist designed to improve NASH by increasing hepatic fat metabolism and reducing lipotoxicity. We aimed to assess the safety and efficacy of resmetirom in patients with NASH.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hercules Credit Facility
Deal Size: $255.0 million Upfront Cash: Undisclosed
Deal Type: Financing December 21, 2022
Details:
MAESTRO-NASH, a registrational Phase 3 trial, has achieved both liver histological improvement endpoints that FDA proposed as reasonably likely to predict clinical benefit to support accelerated approval for the treatment NASH with liver fibrosis.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2022
Details:
Madrigal’s lead candidate, MGL-3196 (resmetirom), is a once daily, oral, thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2022
Details:
Late-breaking data from double-blind portion of noninvasive Phase 3 MAESTRO NAFLD-1 study show MGL-3196 (resmetirom) to be safe and well-tolerated and to reduce liver fat, fibrosis measures on FibroScan and MRE, and liver enzymes, as well as multiple atherogenic lipids.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 25, 2022
Details:
Resmetirom (MGL-3196) is a liver-directed, orally active, selective thyroid hormone receptor-β agonist designed to improve NASH by increasing hepatic fat metabolism and reducing lipotoxicity.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2022
Details:
Madrigal’s lead candidate, resmetirom, is a first-in-class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR)-β selective agonist that is currently in two Phase 3 clinical studies, MAESTRO-NASH and MAESTRO- NAFLD-1.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 30, 2021
Details:
The MAESTRO-NAFLD-1 study revealed that Patients treated with 100 mg per day of resmetirom for up to 52 weeks achieved rapid and sustained improvements in multiple clinically relevant NASH endpoints and resmetirom continues to be well-tolerated.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 12, 2021
Details:
Madrigal will continue to enroll additional patients beyond those required for accelerated approval to provide for the clinical outcomes portion of the MAESTRO-NASH Phase 3 clinical trial of resmetirom.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2021
Details:
Resmetirom is the first orally administered, small-molecule, liver-directed, truly β-selective thyroid hormone receptor (THR) agonist and is currently in Phase 3 development for the treatment of NASH patients both with biopsy-confirmed fibrosis stage 2-3.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 13, 2020
Details:
Resmetirom is a liver-directed, small-molecule and a truly β-selective thyroid hormone receptor agonist. Madrigal has completed enrollment in its MAESTRO NAFLD-1 trial of resmetirom in patients with presumed NASH who are diagnosed using non-invasive assessments.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2020
Details:
The data from the ongoing open label arm of MAESTRO-NAFLD-1 confirm the robust effects of a 100 mg dose of resmetirom with direct actions in the liver at 16 weeks to significantly reduce both hepatic fat on serial MRI-PDFF as well as meaningfully reduce liver fibrosis.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 01, 2020
Details:
Recent presentations at EASL Digital ILC of secondary analysis of Ph2 data demonstrated that reduction in MRI-PDFF can predict improvement in all components of histologic response in NASH, including steatosis, ballooning, inflammation and fibrosis.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2020
Details:
MRI-PDFF reduction has been shown to be associated with improvement in NASH components as assessed on liver biopsy. These secondary analyses of Madrigal’s Phase 2 NASH clinical trial add significant additional insight into the potential of PDFF to predict NASH response.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MGL-3196
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 26, 2020
Details:
Once daily oral 80 mg and 100 mg Phase 3 doses of resmetirom deliver at least 50% to more than 60% reductions in liver fat, respectively.
Lead Product(s): Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 14, 2020
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