Madrigal Pharmaceuticals Announces Rolling Submission Of New Drug Application To U.S. FDA Seeking Accelerated Approval Of Resmetirom For The Treatment Of NASH With Liver Fibrosis
Portfolio Pulse from Happy Mohamed
Madrigal Pharmaceuticals has initiated a rolling submission of a New Drug Application (NDA) to the U.S. FDA for accelerated approval of resmetirom, a treatment for nonalcoholic steatohepatitis (NASH) with liver fibrosis. The company plans to complete the submission in July 2023. Resmetirom was granted Breakthrough Therapy designation in April 2023. Madrigal is currently conducting four Phase 3 clinical trials to demonstrate the safety and efficacy of resmetirom.
June 30, 2023 | 12:11 pm
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POSITIVE IMPACT
Madrigal Pharmaceuticals' stock could see positive movement as the company seeks accelerated FDA approval for its drug resmetirom. The completion of the submission process in July 2023 could serve as a significant milestone.
The news of Madrigal Pharmaceuticals seeking accelerated FDA approval for its drug resmetirom is directly related to the company and its future prospects. If approved, this could significantly boost the company's revenue and profitability, leading to a potential increase in its stock price.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 100