Please ensure Javascript is enabled for purposes of website accessibility

Here's Why Cytokinetics Is Skyrocketing 24.5% Today

By Todd Campbell - May 11, 2020 at 12:21PM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

The Food and Drug Administration is fast-tracking the biotech's lead drug candidate.

What happened

After the company disclosed that the Food and Drug Administration has awarded fast-track status to its lead drug candidate, omecamtiv mecarbil, shares in Cytokinetics (CYTK 3.04%) are surging 24.5% higher at 12:00 pm EST on Monday.

So what

Omecamtiv mecarbil is currently under evaluation by the biotech company in a large-scale phase 3 clinical trial, GALACTIC-HF, that's expected to have top-line results available in Q4, 2020. Since the treatment has the potential to help heart patients with reduced ejection fraction, the FDA awarded it a fast-track designation, which provides increased FDA guidance and a streamlined process of application for approval. 

A rocket lifting off into the sky.


A cardiac myosin activator, omecamtiv mecarbil stimulates a heart muscle protein responsible for causing the heart to contract and pump blood, potentially resulting in better cardiac function. Its GALACTIC-HF phase 3 study, which is being conducted in conjunction with collaboration partner Amgen (AMGN 0.79%), is determining if adding the therapy to standard care can reduce the risk of future heart failure events and death in heart failure patients. 

The trial has enrolled 8,256 patients in 35 countries who were hospitalized for the primary reason of heart failure or had a hospitalization or admission to an emergency room for heart failure within the past year.

Now what

The market potential for omecamtiv mecarbil is massive. Heart failure affects over 64 million people globally, and roughly half of those patients have reduced left ventricular function, suggesting they could benefit from the treatment. The number of heart patients is expected to climb as baby boomers get older, because approximately 20% of people over age 40 are at risk of developing heart failure. Because about 50% of heart failure patients pass away within five years of their initial hospitalization, there's significant need for new treatment options. 

If the drug is approved, Cytokinetics can receive up to $600 million in clinical-stage and commercial milestones, plus royalties on sales. Additionally, an agreement in which Cytokinetics is paying $40 million in phase 3 development gave it an increased royalty payout and the potential to co-commercialize omecamtiv mecarbil in institutional care settings in North America. Separately, Servier has licensed exclusive rights to market the treatment in Europe. 


Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Cytokinetics, Incorporated Stock Quote
Cytokinetics, Incorporated
$48.74 (3.04%) $1.44
Amgen Inc. Stock Quote
Amgen Inc.
$245.43 (0.79%) $1.92

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
S&P 500 Returns

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 06/29/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.