Shares of Myokardia Inc (NASDAQ:MYOK) are down nearly 3% Tuesday as investors digest the biotech firm’s third-quarter financial results. The company reported Q3 EPS of $(0.42) in line with street consensus, and reflecting a total net loss for the quarter of $14.2 million.
MyoKardia also provided an update on the company’s End-of-Phase 2 meeting with the FDA Division of Cardiovascular and Renal Products. The meeting focused on MyoKardia’s proposed registration program for mavacamten (formerly MYK-461) in symptomatic, obstructive hypertrophic cardiomyopathy (oHCM). MyoKardia is incorporating guidance from the FDA on study design elements and plans to proceed with the pivotal Phase 3 trial, EXPLORER-HCM, and a long-term extension study, as the key remaining studies in the mavacamten registration program. The company anticipates dosing the first patient in EXPLORER-HCM in the second quarter of 2018. Between now and study start, the company plans to review the final trial design with the FDA.
Myokardia CEO Tassos Gianakakos stated, “It has been a remarkable quarter for MyoKardia, highlighted by the PIONEER-HCM Phase 2 results and by our meeting with the FDA further clarifying our path to registration for mavacamten […] The progress we’ve made across our clinical pipeline has generated important disease insights that we believe strengthen our research platform. In the months to come, we expect to report important progress in our MYK-491 clinical program for dilated cardiomyopathy, present mavacamten data at the 2017 American Heart Association annual meeting and initiate a Phase 2 study of mavacamten in its second indication, non-obstructed HCM.”
On the ratings front, MyoKardia stock has been the subject of a number of recent research reports. In a report issued on November 3, Cowen analyst Ritu Baral reiterated a Buy rating on MYOK, with a price target of $56, which implies an upside of 41% from current levels. Similarly, on November 2, BMO’s Ian Somaiya reiterated a Buy rating on the stock and has a price target of $65.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ritu Baral and Ian Somaiya have a yearly average return of 23.6% and 14.7% respectively. Baral has a success rate of 52% and is ranked #76 out of 4703 analysts, while Somaiya has a success rate of 48% and is ranked #339.
Overall, 4 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $56.33 which is 41% above where the stock opened today.
MyoKardia engages in the discovery, development, and commercialization of targeted therapies for the treatment of cardiovascular diseases. The company focuses on the treatment of heritable cardiomyopathies, genetically-driven forms of heart failure that result from biomechanical defects in cardiac muscle contraction. It offers MYK-46, an orally-administered small molecule designed to reduce excessive cardiac muscle contractility leading to hypertrophic cardiomyopathy.