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MYOK

MyoKardia

$50.37

-3.1 (-5.80%)

07:42
10/30/18
10/30
07:42
10/30/18
07:42

MyoKardia announces pipeline updates at its R&D Day

MyoKardia announced an update on its clinical-stage and emerging pipeline at its R&D Day. MyoKardia shared interim data from the PIONEER Open-Label Extension, or OLE, study of mavacamten for the treatment of symptomatic oHCM. Twelve of twenty patients with oHCM who previously completed MyoKardia's Phase 2 PIONEER-HCM trial have enrolled in PIONEER-OLE, and seven patients have completed a twelve-week assessment. Despite treatment with therapies such as beta blockers and calcium channel blockers, patients entered PIONEER-OLE with significant left ventricular outflow tract, or LVOT, obstruction. Following resumed mavacamten treatment with individualized dosing, evaluable patients in PIONEER-OLE achieved a statistically significant reduction in LVOT obstruction, to a mean provoked gradient of 22.3mmHg. For reference, LVOT obstruction is defined as a gradient of 30.0mmHg or greater at rest and a gradient of greater than 50.0mmHg is considered to be hemodynamically significant. In MyoKardia's Phase 2 PIONEER-HCM clinical trial of mavacamten, reductions in LVOT obstruction correlated to improvements in patients' symptoms and exercise capacity. All patients maintained ejection fractions well in the normal range of greater than 50%. There have been no significant adverse events reported. The longest duration of treatment thus far has been 25 weeks. MyoKardia plans to present additional data from PIONEER-OLE in Q1 of 2019, including gradient and ejection fraction data from longer term exposures, NT-proBNP and NYHA functional classification changes. MyoKardia announced the expansion of its pipeline with MYK-224, a second HCM-targeted candidate with differentiated pharmaceutical properties. Like mavacamten, MYK-224 is designed to correct excess contractility and address impaired diastolic function, without affecting myosin-actin cross-bridge kinetics or inducing an increase in calcium transient or energy burden. MYK-224 has been optimized to enable rapid dose adjustment and simplify dose finding in patients. MyoKardia plans to initiate a Phase 1 clinical trial in 2019 followed by a Phase 2a trial in 2020 addressing a complementary HCM population to mavacamten. MyoKardia shared preclinical data from its emerging LUS-1 program, a class of agents targeted at improving diastolic compliance, or the ability of the heart to relax and fill. Experience in preclinical studies and observations from clinical trials of mavacamten suggests that it may improve diastolic function and compliance. Building on these data, MyoKardia has discovered compounds that improve diastolic compliance with minimal impact on contractility. Preclinical data were shared that demonstrate that MyoKardia's proprietary agents successfully uncouple contractility inhibition from improved diastolic compliance, with a net positive impact on stroke volume. MyoKardia plans to share more mavacamten clinical data relating to its potential diastolic benefits at the upcoming American Heart Association Annual Meeting in November and will disclose additional preclinical data in relevant disease models for its LUS-1 program in 2019.

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MYOK MyoKardia
$50.37

-3.1 (-5.80%)

08/09/18
WEDB
08/09/18
NO CHANGE
Target $77
WEDB
Outperform
MyoKardia price target raised to $77 from $64 at Wedbush
Wedbush analyst David Nierengarten raised his price target for MyoKardia (MYOK) to $77 from $64 as he now begins to value royalties on potential sales of mavacamten and MYK-491 in Europe based on increasing confidence that Sanofi (SNY) will elect to commercialize there. The analyst is also positive on MyoKardia ahead of the Phase 1b MYK-491 readout in dilated cardiomyopathy later this year, where a favorable safety profile and demonstration of clinical proof of mechanism could add at least $5/share to current levels. He reiterates an Outperform rating on MyoKardia shares.
09/10/18
MSCO
09/10/18
INITIATION
Target $72
MSCO
Overweight
MyoKardia initiated with an Overweight at Morgan Stanley
Morgan Stanley analyst Jeffrey Hung initiated MyoKardia (MYOK) at Overweight with a $72 price target, stating that the obstructive hypertrophic cardiomyopathy Phase 2 data for its lead program, mavacamten, were "robust" and the fact that the company is partnered with Sanofi (SNY) gives him incremental confidence. He expects a mavacamten launch in oHCM in early 2022 and peak U.S. sales for the drug of greater than $1.3B.
09/28/18
SBSH
09/28/18
INITIATION
Target $90
SBSH
Buy
MyoKardia initiated with a Buy at Citi
Citi analyst Mohit Bansal started MyoKardia with a Buy rating and $90 price target. Early data for the company's lead program Mavacamten in hypertrophic cardiomyopathy indicated significant improvement in obstruction and function, Bansal tells investors in a research note. His analysis and physician checks make him confident around questions of long term safety and efficacy.
10/01/18
CANT
10/01/18
INITIATION
Target $90
CANT
Overweight
MyoKardia initiated with an Overweight at Cantor Fitzgerald
Cantor Fitzgerald analyst Alethia Young started MyoKardia with an Overweight rating and $90 price target.

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