Upon releasing positive data for lead drug candidate Mavacamten on Monday, investors flocked to Myokardia Inc (NASDAQ:MYOK), sending the stock soaring by 83%. The drug, which is designed to treat patients suffering from obstructive hypertrophic cardiomyopathy (oHCM), passed the Phase 2 trial with flying colors, beating out expectations.
Analyst Ritu Baral of Cowen notes that the study satisfied the FDA’s desired pivotal endpoint and met its own primary endpoint in regard to the left ventricular outflow tract (LVOT) along with the secondary endpoint of measuring normal mixed venous oxygen tension (pVO2).
Furthermore, Baral mentions that 9 of 10 patients suffering from inheritable cardiomyopathies saw significant improvement within just two weeks of testing. In the wake of meetings with the FDA and the encouraging data from Phase 2, Baral expects the company to begin the next major study on the drug before the end of the year.
The analyst is confident that the drug will be a catalyst for the company moving forward and that MYOK is well-positioned in the biotech industry to become a leader in treating cardiovascular disease. The analyst writes: “PIONEER met statistical significance on key secondary peak VO2 (pVO2), the potential pivotal endpoint of important to FDA. pVO2 is a measure of functional capacity the FDA deemed supportive of full approval in oHCM. Even though EXPLORED was not powered for this endpoint, the results are clear and the drug induced clinically and statistically significant improvements in pVO2 by the end of the 12 week treatment period (pVO2 was increased to 24.6 on average, from a baseline. We think Myokardia has a very promising platform of therapies for precision medicine cardiomyopathies, including a series of lead compounds for genetically defined/heritable ardiomyopathies. Myokardia is one of the very few biotechnology companies today focused on improving heart muscle function for cardiovascular diseases.”
On the financial front, the company ended the second quarter with $117 million on its balance sheet and a total net loss of $12.88 million. Earnings per share were more or less in-line with consensus at $0.41 vs. $0.37 and Baral believes that the financial state of the company “should suffice to support operation for at least 12 months.” Additionally, in reflecting the current patient market, the analyst has set expectations for oHCM peak sales in the US to $1.2 billion and $793 million in the EU.
The analyst reiterates an Outperform rating on MYOK while raising the price target from $28.00 to $56.00, representing a 78% increase from where the shares last closed. (To watch Baral’s track record, click here)
TipRanks analytics demonstrate MYOK as a Strong Buy. Out of 3 analysts polled by TipRanks in the last 3 months, all 3 are bullish on Myokardia stock. With an upside potential of 14%, the stock’s consensus target price stands at $36.00.