Cytokinetics, Incorporated CYTK announced that the FDA has granted a Breakthrough Therapy designation to its investigational candidate, aficamten, for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
The Breakthrough Therapy designation is granted to medicines being evaluated for serious conditions where early clinical evidence indicates the potential for substantial improvement using available therapy.
The above-mentioned Breakthrough Therapy designation was granted based on data from the cohorts 1 and 2 of the phase II REDWOOD-HCM study that evaluated aficamten in patients with symptomatic oHCM.
Data from the same showed that treatment with aficamten for 10 weeks led to statistically significant reductions from baseline in the average resting left ventricular outflow tract pressure gradient (LVOT-G) and the average post-Valsalva LVOT-G versus placebo. Also, patients treated with aficamten experienced improvements in their heart failure symptoms. Treatment with aficamten was generally well tolerated.
The company has also completed enrollment in the cohort 3 of the REDWOOD-HCM study for patients whose background therapy includes disopyramide. Data from this cohort is expected in the first quarter of 2022.
Shares of Cytokinetics have skyrocketed 68.6% so far this year against the industry’s decrease of 19.6%.
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We note that aficamten, a next-generation cardiac myosin inhibitor, is being developed for the potential treatment of HCM. The company is preparing the start-up activities for another phase III study – SEQUOIA-HCM – evaluating aficamten in patients with symptomatic oHCM.
Cytokinetics is developing its lead drug candidate, omecamtiv mecarbil, a cardiac myosin activator, for treating patients with heart failure.
Based on positive data from the phase III GALACTIC-HF study, the company is planning to submit a new drug application for omecamtiv mecarbil in the United States shortly.
Cytokinetics is also evaluating another pipeline candidate, reldesemtiv, in a phase III study for the treatment of patients with amyotrophic lateral sclerosis.
Zacks Rank & Stocks to Consider
Cytokinetics currently carries a Zacks Rank #4 (Sell).
Better-ranked stocks in the biotech sector include Sarepta Therapeutics, Inc. SRPT, Editas Medicine, Inc. EDIT and vTv Therapeutics Inc. VTVT, all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sarepta Therapeutics’ loss per share estimates have narrowed 31.3% for 2021 and 26% for 2022, over the past 60 days.
Earnings of Sarepta Therapeutics have surpassed estimates in two of the trailing four quarters, and missed the same on the other two occasions.
Editas Medicine’s loss per share estimates have narrowed 11.2% for 2021 and 4.6% for 2022, over the past 60 days.
Editas Medicine’s earnings have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions.
vTv Therapeutics’ loss per share estimates have narrowed 21.7% for 2021 and 2.9% for 2022, over the past 60 days.
vTv Therapeutics’ earnings have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
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