Madrigal Pharmaceuticals (MDGL) finished the trading session today 268.07% higher at $234.83 after unexpected positive topline results from the Pivotal Phase 3 MAESTRO-NASH Clinical Trial of its drug Resmetirom for the treatment of NASH and liver fibrosis. NASH is a fatty liver disease.
MAESTRO-NASH, a Phase 3 trial, has achieved both liver histological improvement endpoints that FDA proposed as reasonably likely to predict clinical benefit to support accelerated approval for the treatment NASH with liver fibrosis.
The Chief Medical Officer (CME) and President of Research of Madrigal Pharmaceuticals, Becky Taub, M.D., , commented on the results:
These pivotal Phase 3 results demonstrate the potential for resmetirom to help patients achieve improvement in both the underlying steatohepatitis that drives this disease and the resulting fibrosis that is associated with progression to cirrhosis and its complications. The topline data also reinforce our confidence in the safety and tolerability profile of resmetirom. We believe the Phase 3 MAESTRO clinical development program, including the MAESTRO-NAFLD-1 and MAESTRO-NAFLD-OLE safety clinical trials and the recently initiated MAESTRO-NASH-OUTCOMES clinical trial, provides a strong foundation for our new drug application (NDA) and the potential accelerated approval of resmetirom for the treatment of non-cirrhotic NASH with liver fibrosis.”Chief Medical Officer (CME) and President of Research of Madrigal Pharmaceuticals, Becky Taub, M.D.
Madrigal Pharmaceuticals is planning to ask the FDA to approve its Resmetirom drug, for NASH treatment. If approved, it would be the first to treat fibrosis due to NASH.
Madrigal Pharmaceuticals (MDGL) Stock
Madrigal market capitalization now stands at $4.016 billion. MDGL stock has a 52-week trading range between $52.33 to $236.39. The trading volume today jumped to 8.8 million stocks compared to a daily average of 300,000. Madrigal Pharmaceuticals has 17.1 million shares outstanding and the public float is 12.41 million. The short interest is 2.16 million or 17.40% of the shares.
After the announcement, Raymond James upgraded Madrigal Pharmaceuticals (MDGL) from Underperform to Market Perform.
Madrigal Pharmaceuticals Third Quarter Financial Results
Madrigal reported Operating expenses of $80.4 million and $208.3 million for the three month and nine month periods, compared to $63.2 million and $177.9 million in the same period of 2021.
MDGL had cash and cash equivalents of $153.2 million at the end of quarter, compared to $270.3 million at the end of 2021.
Research and development expenses for the quarter were $68.3 million, compared to $54.9 million in the third quarter of 2021. General and administrative expenses for the Q3 were $12.1 million, compared to $8.3 million in the Q3 2021.
Interest income for the third quarter was $0.7 million, compared to $0.1 million in the third quarter of 2021. The rise in interest income were due to higher average interest rates since the beggining of the year.
Nikolas has been involved in the finance industry for over fifteen years spanning across Europe and USA with a depth of knowledge and experience within many aspects of the financial markets. Nikolas gained several years experience with some of the Europe’s leading Brokers, as equity analyst, and trader managing accounts for both Private and Corporate Investors. He enjoys both the fundamental and technical aspects of trading focusing on stock markets and all FX majors. Currently, Nikolas provides analysis and comments to online financial publications. Educational background in Economics (BSc), and Finance (MSc).