Please ensure Javascript is enabled for purposes of website accessibility
Free Article Join Over 1 Million Premium Members And Get More In-Depth Stock Guidance and Research

Why Ionis Pharmaceuticals Inc. Skyrocketed Higher Today

By Brian Orelli, PhD - Nov 7, 2016 at 12:50PM

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

More positive phase 3 data for its SMA drug Spinraza sends shares of the biotech soaring.

Image source: Getty Images.

What happened

Ionis Pharmaceuticals ( IONS 0.92% ) is up 20.8% at noon EST, after announcing with its partner Biogen ( BIIB -2.01% ) that their spinal muscular atrophy (SMA) drug nusinersen, which now goes by the branded name Spinraza, passed another phase 3 trial. Because Biogen is larger and not as dependent on Spinraza as Ionis, Biogen's shares are only up 7%.

So what

Earlier this year, the duo announced that Spinraza helped infants with type 1 SMA. The announcement today is for children with later-onset SMA, who fall into the type 2 class.

The results come from an interim look at the data, which caused the study to be stopped early because it was clear the drug was working. Specifically, over the 15 months patients took Spinraza, they had a mean improvement of 4.0 points on a test that measures different functional motor skills. Untreated patients had a decline of 1.9 points.

While it seemed likely that Spinraza would probably help type 2 patients since it was working in type 1 patients, some of today's gain is probably because of the magnitude of the difference between Spinraza-treated patients and the control group. Improved motor function implies that the children will live longer, which means they'll be taking the drug for a longer time, increasing sales.

Now what

Ionis and Biogen have already submitted marketing applications to the U.S. Food and Drug Administration and to European regulators. On Biogen's third-quarter conference call last month, Michael Ehlers, its head of research and development, said, "We've included data across all of our studies as well as preclinical data. We are going to seek a broad label for the treatment of SMA." Looks like Biogen is going to have to stuff a little more data into the application, which should help it get that "broad label" -- that is, approved for as many patients as possible.

Normally, adding data after an application is submitted causes an automatic delay of an FDA decision, but Biogen has said the agency is motivated to review the application quickly, given the unmet need for SMA treatments. Even if the submission causes a delay in approval, it'll still result in more sales for Biogen and Ionis, compared to waiting for an approval in type 1 SMA and then submitting a supplementary marketing application to get a second approval in type 2 SMA.

This article represents the opinion of the writer, who may disagree with the “official” recommendation position of a Motley Fool premium advisory service. We’re motley! Questioning an investing thesis – even one of our own – helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.

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

Ionis Pharmaceuticals, Inc. Stock Quote
Ionis Pharmaceuticals, Inc.
IONS
$26.39 (0.92%) $0.24
Biogen Inc. Stock Quote
Biogen Inc.
BIIB
$223.92 (-2.01%) $-4.60

*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 service.

Stock Advisor Returns
624%
 
S&P 500 Returns
140%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 12/05/2021.

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

Our Most Popular Articles

Premium Investing Services

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