Madrigal

Madrigal Pharmaceuticals Appoints Carole Huntsman as Chief Commercial Officer

Retrieved on: 
Friday, November 10, 2023
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CONSHOHOCKEN, Pa., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that Carole Huntsman has been appointed Chief Commercial Officer.

Key Points: 
  • CONSHOHOCKEN, Pa., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that Carole Huntsman has been appointed Chief Commercial Officer.
  • This included executing the launch of Dupixent, a first-in-class therapy which has grown into an industry-leading medicine.
  • In 2022, Ms. Huntsman’s business unit was responsible for over $10 billion in annual net sales.
  • Bill Sibold, Chief Executive Officer of Madrigal, stated, “Carole Huntsman’s leadership skills and experience are a perfect fit for Madrigal as we prepare for a first-to-market launch of resmetirom in the U.S. She has an extensive track record of specialty launch success and excels in building and leading high-performing teams that deliver innovative new therapies to patients with serious diseases.

Madrigal Pharmaceuticals Provides Corporate Updates and Reports Third Quarter 2023 Financial Results

Retrieved on: 
Monday, November 6, 2023
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At the AASLD Liver Meeting next week, we will present a comprehensive analysis of noninvasive tests and imaging from the MAESTRO-NASH trial.

Key Points: 
  • At the AASLD Liver Meeting next week, we will present a comprehensive analysis of noninvasive tests and imaging from the MAESTRO-NASH trial.
  • The Agency noted that it is not currently planning to hold an advisory committee meeting to discuss the application.
  • In October 2023, we completed a public offering and received an additional $472.0 million in net cash proceeds.
  • These increases in interest income were due primarily to higher average interest rates in 2023.

Madrigal Pharmaceuticals Announces Participation at Three Upcoming Investor Conferences

Retrieved on: 
Thursday, November 2, 2023
NASH, Fatty liver disease, Webcast, Therapy, Pharmaceutical industry, Madrigal

CONSHOHOCKEN, Pa., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), announced today its management team will participate in fireside chats at three upcoming investor conferences:

Key Points: 
  • CONSHOHOCKEN, Pa., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), announced today its management team will participate in fireside chats at three upcoming investor conferences:
    5:00 pm ET on Wednesday, November 8, 2023.
  • 3:00 pm ET on Wednesday, Nov 29, 2023.
  • 1:00 pm ET on Thursday, November 30, 2023.
  • The fireside chats will be webcast and archived recordings will be available for replay in the Investors section of the Madrigal website after the events.

Madrigal Pharmaceuticals Announces Pricing of $500 Million Public Offering

Retrieved on: 
Friday, September 29, 2023
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The gross proceeds to Madrigal from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $500 million.

Key Points: 
  • The gross proceeds to Madrigal from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $500 million.
  • Madrigal has granted the underwriters of the offering a 30-day option to purchase up to an additional 494,429 shares of common stock from the company at the public offering price, less underwriting discounts and commissions.
  • Goldman Sachs & Co. LLC, Jefferies, TD Cowen, Evercore ISI and Piper Sandler are acting as joint bookrunning managers of the offering.
  • The offering is expected to close on October 3, 2023, subject to the satisfaction of customary closing conditions.

Madrigal Pharmaceuticals Announces Proposed Public Offering

Retrieved on: 
Thursday, September 28, 2023
Attention, Lexington Avenue, Therapy, NASH, TD, Telephone, Jefferies, Research, Goldman Sachs, Sale, Evercore, Public expenditure, Prospectus, Jefferies Group, Equity capital markets, ATTN:, Form, Madison Avenue, Fatty liver disease, Nicollet Mall, Security (finance), Madrigal

Madrigal also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock offered in the public offering at the public offering price, less underwriting discounts and commissions.

Key Points: 
  • Madrigal also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock offered in the public offering at the public offering price, less underwriting discounts and commissions.
  • All of the shares in the proposed offering are to be sold by Madrigal.
  • Goldman Sachs & Co. LLC, Jefferies, TD Cowen, Evercore ISI and Piper Sandler are acting as joint bookrunning managers of the proposed offering.
  • The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Madrigal Pharmaceuticals Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Thursday, September 14, 2023
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CONSHOHOCKEN, Pa., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that it made an inducement grant to Bill Sibold on September 11, 2023 in connection with his appointment as Madrigal’s new President and Chief Executive Officer.

Key Points: 
  • CONSHOHOCKEN, Pa., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that it made an inducement grant to Bill Sibold on September 11, 2023 in connection with his appointment as Madrigal’s new President and Chief Executive Officer.
  • The award was granted outside of the company’s Amended 2015 Stock Plan under the terms of the company's 2023 Inducement Plan (which was approved and adopted by the Board of Directors on September 8, 2023) and was approved by the company’s Compensation Committee in accordance with Nasdaq Listing Rule 5635(c)(4).
  • In addition, on September 14, 2023, Madrigal granted equity awards under the 2023 Inducement Plan to eight other new employees as a material inducement to their employment, all of which were approved in accordance with Nasdaq Listing Rule 5635(c)(4).
  • These employees received, in the aggregate, 12,989 time-based restricted stock units, which vest ratably over four years, subject to each such employee’s continued employment as of the vesting date.

Madrigal Pharmaceuticals Announces NDA Acceptance and Priority Review of the New Drug Application for Resmetirom for the Treatment of NASH with Liver Fibrosis

Retrieved on: 
Wednesday, September 13, 2023
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The Agency noted that it is not currently planning to hold an advisory committee meeting to discuss the application.

Key Points: 
  • The Agency noted that it is not currently planning to hold an advisory committee meeting to discuss the application.
  • Resmetirom is a once daily, oral, thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver.
  • Madrigal is seeking approval of resmetirom for the treatment of patients with NASH and liver fibrosis under the FDA’s accelerated approval pathway.
  • A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review).

Madrigal Pharmaceuticals Appoints Bill Sibold as Chief Executive Officer

Retrieved on: 
Monday, September 11, 2023
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CONSHOHOCKEN, Pa., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that Bill Sibold has succeeded Paul Friedman, M.D., as Chief Executive Officer (CEO) and joined Madrigal’s Board of Directors.

Key Points: 
  • CONSHOHOCKEN, Pa., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that Bill Sibold has succeeded Paul Friedman, M.D., as Chief Executive Officer (CEO) and joined Madrigal’s Board of Directors.
  • Paul has built an outstanding team and his many contributions to the biopharmaceutical industry will continue to impact the lives of patients for years to come.”
    Mr. Baker continued, “Bill Sibold is an ideal leader to guide Madrigal into its next phase of growth.
  • Previously, Mr. Sibold served as Chief Commercial Officer of Avanir Pharmaceuticals, President and CEO of Lycera Corp., and SVP U.S. Commercial for Biogen.
  • Mr. Sibold stated, “I am excited to join Madrigal at this pivotal moment.

Madrigal Pharmaceuticals Provides Corporate Updates and Reports Second Quarter 2023 Financial Results

Retrieved on: 
Tuesday, August 8, 2023
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Resmetirom new drug application (NDA) submitted to the U.S. Food and Drug Administration

Key Points: 
  • Resmetirom new drug application (NDA) submitted to the U.S. Food and Drug Administration
    NASH disease education and market development activities expand to support potential first-to-market launch in the U.S.
    CONSHOHOCKEN, Pa., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today provides a summary of recent corporate accomplishments and reports second quarter 2023 financial results.
  • Paul Friedman, M.D., Chief Executive Officer of Madrigal, stated, “The recent submission of the resmetirom NDA represents an important milestone for Madrigal and the NASH community.
  • Madrigal presented the Phase 3 MAESTRO-NASH primary results during the opening general session of the EASL Congress™.
  • Financial Results for the Six Months Ended June 30, 2023
    As of June 30, 2023, Madrigal had cash, cash equivalents and marketable securities of $298.4 million, compared to $358.8 million at December 31, 2022.

Madrigal Pharmaceuticals Completes Submission of New Drug Application Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis

Retrieved on: 
Monday, July 17, 2023
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Resmetirom is a once daily, oral, thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver.

Key Points: 
  • Resmetirom is a once daily, oral, thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver.
  • In the pivotal Phase 3 MAESTRO-NASH serial liver biopsy trial, resmetirom achieved both liver histological improvement endpoints – resolution of NASH and reduction of liver fibrosis – proposed by FDA as reasonably likely to predict clinical benefit to support accelerated approval for the treatment of NASH with liver fibrosis.
  • In April 2023, resmetirom was granted Breakthrough Therapy designation by FDA for the treatment of adults with NASH with liver fibrosis.
  • We’d like to thank the many patients and investigators who have contributed to the clinical research supporting the resmetirom NDA.”