CONSHOHOCKEN, PA — Following an exciting first quarter, Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) has reported great strides in both research and financial achievements. Among the most significant is the FDA approval and subsequent launch of its groundbreaking treatment for nonalcoholic steatohepatitis (NASH) with advanced liver fibrosis – a disease previously without any FDA-approved therapies.
Rezdiffra ™ (resmetirom), Madrigal’s innovative, once-daily oral medication received an FDA approval on March 14, 2024. This approval marks a historic moment as the first and only FDA-approved therapy for NASH. Patients with NASH, sometimes referred to as “MASH”, tend to develop serious and progressive liver disease. This highlights the significance of Rezdiffra’s introduction to the pharmaceutical market.
According to Madrigal, approximately 1.5 million individuals have been diagnosed with NASH within the United States alone. Out of them, roughly 525,000 have NASH with serious liver fibrosis. Madrigal focuses on the 315,000 diagnosed patients with advanced liver fibrosis who are currently under the care of specialist physicians.
Bill Sibold, Chief Executive Officer of Madrigal, stated, “Madrigal is the first company to deliver an approved therapy for patients with NASH, which we believe will give us a strong competitive advantage for many years to come.” He further added that the company anticipates substantial enthusiasm from key stakeholders for Rezdiffra.
The results of the Phase 3 MAESTRO-NASH study, published in The New England Journal of Medicine, showcased the efficacy of Rezdiffra, with improvement or cessation of fibrosis in more than 80% of patients.
In financial news, Madrigal closed an upsized public offering on March 21, 2024, which generated gross proceeds of $600 million. On April 2, the company’s underwriters exercised their option to purchase additional shares, resulting in another $90 million in gross revenue. The net proceeds totaling $660 million will contribute to strengthening the Rezdiffra launch.
As of March 31, 2024, Madrigal reported having cash, cash equivalents, and marketable securities amounting to $1.1 billion, a marked increase from the $634.1 million held at the end of 2023.
This momentous approval opens doors for the European market as well. In March, Madrigal announced that its Marketing Authorization Application for resmetirom is under evaluation with the European Medicines Agency’s Committee for Medicinal Products for Human Use. If approved, it will be the first therapy for patients with NASH with liver fibrosis in Europe.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.