Cytokinetics, Incorporated CYTK announced that the FDA has accepted the company’s new drug application (NDA) for lead pipeline candidate, aficamten.
Aficamten is a next-in-class cardiac myosin inhibitor. The NDA is seeking approval of the candidate for the treatment of obstructive hypertrophic cardiomyopathy (HCM).
Year to date, Cytokinetics’ shares have lost 39.5% compared with the industry’s 7% decline.
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CYTK’s NDA Acceptance
The regulatory body assigned a standard review to the NDA and set a target action date of Sept. 26, 2025.
The FDA also informed the company that it is not planning to hold an advisory committee meeting to discuss the application.
The NDA is supported by the results from the phase III SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM) study on aficamten in patients with symptomatic obstructive HCM.
Results from SEQUOIA-HCM showed that treatment with aficamten for 24 weeks significantly improved exercise capacity compared to placebo, increasing peak oxygen uptake measured by cardiopulmonary exercise testing by 1.8 ml/kg/min compared to baseline in patients treated with aficamten versus 0.0 ml/kg/min in patients treated with placebo.
Statistically significant improvements were observed in all 10 prespecified secondary endpoints. Treatment-emergent serious adverse events occurred in 5.6% and 9.3% of patients on aficamten and placebo, respectively. Core echocardiographic left ventricular ejection fraction (LVEF) was less than 50% in five patients on aficamten compared to one on placebo. There were no instances of worsening heart failure or treatment interruptions due to low LVEF.
Additional analyses from SEQUOIA-HCM have demonstrated that treatment with aficamten is associated with favorable cardiac remodeling as well as improvements in cardiac structure, function and biomarkers without negatively impacting systolic function.
We remind investors that the FDA had granted orphan drug designation to aficamten for the treatment of symptomatic HCM in January 2021. It also granted Breakthrough Therapy Designation in December 2021 for treating obstructive HCM.
A potential approval and the successful development of the candidate will be a significant boost for late-stage, specialty cardiovascular biopharmaceutical company, CYTK, as it currently does not have any approved product in its portfolio.
CYTK’s Pipeline Progress
Aficamten is also currently being evaluated in MAPLE-HCM, a phase III clinical trial assessing aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM. FOREST-HCM is an open-label extension clinical study of aficamten in patients with HCM.
Meanwhile, Bayer AG BAYRY will acquire rights to aficamten in Japan. As per the joint development plan, Bayer plans to conduct a phase III study in Japanese patients with obstructive HCM. On the other hand, Cytokinetics will expand ACACIA-HCM, the ongoing global late-stage study of aficamten in patients with non-obstructive HCM, into Japan. This study is intended to support the potential marketing authorization of aficamten in Japan for Bayer. CYTK will also expand CEDAR-HCM, its ongoing study for pediatric patients with obstructive HCM.
Per the financial terms of the agreement, Cytokinetics will receive an upfront payment of €50 million and an additional €90 million upon achieving milestones through commercial launch, including €20 million, which are near-term. In addition, Cytokinetics is eligible to receive up to €490 million in commercial milestone payments upon achieving certain sales milestones by Bayer and tiered royalties on net sales of aficamten in Japan.
Zacks Rank and Stocks to Consider
Cytokinetics currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the biotech sector are Spero Therapeutics SPRO and Castle Biosciences, Inc. CSTL, both carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.13. Estimates for 2025 loss per share have narrowed from $1.54 to 54 cents.
Spero Therapeutics’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average surprise of 94.42%.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time frame. Year to date, shares of CSTL have surged 44.6%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
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