Following the FDA’s acceptance of Madrigal Pharmaceuticals’ new drug application (NDA) and priority review for its THR-β agonist (resmetirom) in non-alcoholic steatohepatitis (NASH) in September 2023, the company has taken steps to fortify its leadership and financial position to gear up for the imminent launch of resmetirom. The measures initiated by Madrigal for the launch are expected to set the tone for future launches of NASH therapies by other small companies, according to GlobalData, a leading data and analytics company.

In a pivotal move aligning with its vision for resmetirom, Madrigal made strategic changes in its leadership with the addition of two seasoned Sanofi alumni; Bill Sibold as chief executive officer (CEO) and Carole Huntsman as chief commercial officer (CCO).

Sravani Meka, Senior Immunology Analyst at GlobalData, comments: “Madrigal’s recent strategic leadership changes align with industry trends, indicating a positive step towards maximizing the commercial potential in the NASH landscape. It is obvious that the company hopes to leverage the expertise of the Sanofi alumni who have been involved in the successful commercialization of Dupixent, paving the way for patient, healthcare professional, and payer education on resmetirom’s role in NASH treatment.”

In addition to changes in its leadership team, Madrigal has also been proactively engaged in securing financial stability to support resmetirom’s clinical progression and future commercial activities. In December 2022, the company successfully concluded raising a total of $309 million following positive topline data from the pivotal Phase III MAESTRO-NASH clinical trial. Subsequently, in a public offering, Madrigal secured $500 million in late September 2023.

Sravani continues: “While the abovementioned financing endeavors signify substantial progress, it remains to be seen if the funds raised will be sufficient for a comprehensive market entry. As such, Madrigal may be positioning itself to procure a partnership with a more established pharmaceutical company or as an acquisition target to support a successful launch of resmetirom.”

Undoubtedly, with the anticipated launch of resmetirom in the NASH market, a pioneering move, Madrigal will face several inherent challenges.

Sravani concludes: “Of the over 30 late-stage NASH agents in development, most are being developed by small pharmaceutical companies. Therefore, as Madrigal continues to strategically prepare for the imminent market debut of resmetirom, other small companies may look to learn from how the company will aim to navigate the complexities of launching a first-to-market drug in a complex disease market.”