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Madrigal (MDGL) to Raise Capital Via Public Offering of $500M
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Madrigal Pharmaceuticals, Inc. (MDGL - Free Report) priced its public offering of 1.25 million shares of its common stock at $151.69 per share.
The clinical-stage biopharmaceutical company also offered pre-funded warrants to purchase 2.05 million shares of common stock at a price of $151.6899 per pre-funded warrant to certain investors.
Madrigal expects gross proceeds of approximately $500 million from the offering before deducting the underwriting discounts and commissions and other estimated offering expenses.
The underwriters of the offering were granted 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.
Net proceeds from this offering will be primarily used for commercial activities in preparation for a potential launch of resmetirom in the United States. MDGL also expects to use the funds for general corporate purposes, including research and development expenditures, clinical trial expenditures, manufacture and supply of drug substance and drug products, potential acquisitions or licensing of new technologies, capital expenditures and working capital.
Earlier in the month, the FDA accepted for review of Madrigal’s new drug application (NDA) for resmetirom for treating adult patients with nonalcoholic steatohepatitis (NASH) with liver fibrosis.
The regulatory body has granted Priority Review to the NDA with a target action date of Mar 14, 2024.
Resmetirom is a once-daily oral thyroid hormone receptor-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.
The FDA generally grants Priority Review to applications for drugs that, upon approval, would lead to significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions.
With this designation, the FDA generally takes action on an application within 6 months compared with 10 months under standard review.
The successful development and commercialization of resmetirom for NASH will be a significant boost for the company. Madrigal seems to be upbeat about a tentative FDA approval and is gearing up for a launch of the same.
NASH is an advanced form of nonalcoholic fatty liver disease and a leading cause of liver-related mortality. The NASH market holds potential but is quite challenging with no approved therapies.
Earlier in the year, Intercept Pharmaceuticals shelved plans for its NASH treatment.
The decision came after the FDA issued a complete response letter to Intercept’s NDA seeking approval for OCA for treating pre-cirrhotic liver fibrosis due to NASH.
Consequently, Intercept decided to discontinue all NASH-related investments and immediately began the process of closing out the REGENERATE study.
Viking Therapeutics (VKTX - Free Report) is also developing a candidate, VK2809, for biopsy-confirmed NASH and fibrosis. Viking initiated the VOYAGE study, a phase IIb study to evaluate VK2809 in patients with NASH and fibrosis. The study achieved its primary endpoint, with patients receiving VK2809 experiencing statistically significant reductions in liver fat content from baseline to week 12 as compared with placebo.
VKTX expects to report data from the secondary and exploratory objectives of the study, including the evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of treatment, in the first half of 2024.
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Madrigal (MDGL) to Raise Capital Via Public Offering of $500M
Madrigal Pharmaceuticals, Inc. (MDGL - Free Report) priced its public offering of 1.25 million shares of its common stock at $151.69 per share.
The clinical-stage biopharmaceutical company also offered pre-funded warrants to purchase 2.05 million shares of common stock at a price of $151.6899 per pre-funded warrant to certain investors.
Madrigal expects gross proceeds of approximately $500 million from the offering before deducting the underwriting discounts and commissions and other estimated offering expenses.
The underwriters of the offering were granted 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.
Net proceeds from this offering will be primarily used for commercial activities in preparation for a potential launch of resmetirom in the United States. MDGL also expects to use the funds for general corporate purposes, including research and development expenditures, clinical trial expenditures, manufacture and supply of drug substance and drug products, potential acquisitions or licensing of new technologies, capital expenditures and working capital.
Earlier in the month, the FDA accepted for review of Madrigal’s new drug application (NDA) for resmetirom for treating adult patients with nonalcoholic steatohepatitis (NASH) with liver fibrosis.
The regulatory body has granted Priority Review to the NDA with a target action date of Mar 14, 2024.
Resmetirom is a once-daily oral thyroid hormone receptor-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.
The FDA generally grants Priority Review to applications for drugs that, upon approval, would lead to significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions.
With this designation, the FDA generally takes action on an application within 6 months compared with 10 months under standard review.
The successful development and commercialization of resmetirom for NASH will be a significant boost for the company. Madrigal seems to be upbeat about a tentative FDA approval and is gearing up for a launch of the same.
NASH is an advanced form of nonalcoholic fatty liver disease and a leading cause of liver-related mortality. The NASH market holds potential but is quite challenging with no approved therapies.
Earlier in the year, Intercept Pharmaceuticals shelved plans for its NASH treatment.
The decision came after the FDA issued a complete response letter to Intercept’s NDA seeking approval for OCA for treating pre-cirrhotic liver fibrosis due to NASH.
Consequently, Intercept decided to discontinue all NASH-related investments and immediately began the process of closing out the REGENERATE study.
Viking Therapeutics (VKTX - Free Report) is also developing a candidate, VK2809, for biopsy-confirmed NASH and fibrosis. Viking initiated the VOYAGE study, a phase IIb study to evaluate VK2809 in patients with NASH and fibrosis. The study achieved its primary endpoint, with patients receiving VK2809 experiencing statistically significant reductions in liver fat content from baseline to week 12 as compared with placebo.
VKTX expects to report data from the secondary and exploratory objectives of the study, including the evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of treatment, in the first half of 2024.