Back to top

Image: Bigstock

Biogen's New Study to Test Higher Dose of SMA Drug Spinraza

Read MoreHide Full Article

Biogen Inc. (BIIB - Free Report) announced that it has initiated a phase II/III study on its spinal muscular atrophy (SMA) drug Spinraza (nusinersen). The DEVOTE study will evaluate a higher dose of Spinraza to see whether it can provide greater efficacy for the treatment of SMA.

Based on the long-term safety profile and proven efficacy of Spinraza, the DEVOTE study will also evaluate the safety and tolerability of the drug when administered at a higher dose. Moreover, long-term data from the SHINE study showed that treatment with Spinraza demonstrated improvements in or stabilization of motor function in patients aged 21, who are treated for up to almost six years.

Shares of Biogen have lost 21.9% so far this year, underperforming the industry’s decline of 1.1%.

We remind investors that the FDA approved Spinraza in late 2016 for treating both pediatric and adult patients with SMA. Subsequently, in June 2017, the drug was approved in the EU for the same indication.

Notably, Biogen licensed the global rights to develop, manufacture and commercialize Spinraza from Ionis Pharmaceuticals (IONS - Free Report) , a leader in antisense therapeutics.

Spinraza is the first and the only treatment approved for SMA in the United States. The drug has performed beyond expectations witnessing a strong patient uptake in the United States and internationally, and has now become the standard of care in SMA. The drug generated sales of little more than $1 billion during the first of half of 2019, reflecting year-over-year growth of almost 28%.

Notably, Novartis’ (NVS - Free Report) oral gene therapy for SMA Type 1 — Zolgensma — was approved by the FDA for use in children less than 2 years old in May 2019. Meanwhile, Roche (RHHBY - Free Report) and PTC Therapeutics are also evaluating their candidate risdiplam in a broad range of patients with SMA, which if successfully developed and approved, may compete with Spinraza in the future.

Zacks Rank

Biogen currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

5 Stocks Set to Double

Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.

Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.

Today, See These 5 Potential Home Runs >>


In-Depth Zacks Research for the Tickers Above


Normally $25 each - click below to receive one report FREE:


Roche Holding AG (RHHBY) - free report >>

Novartis AG (NVS) - free report >>

Biogen Inc. (BIIB) - free report >>

Ionis Pharmaceuticals, Inc. (IONS) - free report >>