Alexion to Start Pivotal Study on Ultomiris for ALS in Q1

Alexion Pharmaceuticals Inc. ALXN announced plans to start a pivotal phase III study to evaluate its long-acting C5 complement inhibitor, Ultomiris (ravulizumab), in a new indication — amyotrophic lateral sclerosis (ALS). The study will be called CHAMPION-ALS (n~350) and evaluate the efficacy and safety of Ultomiris across a broad ALS patient population. ALS is a neurological disorder characterized by progressive degeneration of nerve cells in the brain and the spinal cord, which control muscles throughout the body.

Alexion submitted an investigational new drug application (IND) for Ultomiris in ALS to the FDA in the fourth quarter of 2019. The company plans to initiate the phase III study in the first quarter of 2020.

The patients in the study will be randomized on a 2:1 basis to receive Ultomiris or placebo every eight weeks after an initial loading dose and may continue to receive their existing standard-of-care treatment for ALS. After 50 weeks, all patients will receive Ultomiris in a two-year, open-label extension phase of the study. The study will be conducted at about 90 sites across North America, Europe and the Asia Pacific.

Alexion’s share price has gained 1% in the past year against the industry’s decline of 1.8%.

 

We remind investors that Ultomiris is approved for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) to be administered every eight weeks. The drug is also approved in the United States for the treatment of atypical hemolytic uremic syndrome (aHUS) in adults and children one month and older.

Ultomiris recorded sales of $168.7 million in the nine months ended Sep 30, 2019.

The label expansion of the drug into additional indications will boost sales further.

Alexion Pharmaceuticals, Inc. Price

 

Alexion Pharmaceuticals, Inc. Price

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Zacks Rank & Other Stocks to Consider

Alexion is currently a Zacks Rank #1 (Strong Buy) stock.

A few similar-ranked stocks in the biotech sector are Anavex Life Sciences Corp. AVXL, ASLAN Pharmaceuticals Ltd. ASLN and Celsion Corp. CLSN. You can see the complete list of today’s Zacks #1 Rank stocks here.

Anavex’s loss per share estimates have narrowed from  64 cents to 48 cents for 2019 and from 67 cents to 42 cents for 2020 in the past 90 days. The company delivered a positive earnings surprise in three of the trailing four quarters by 0.57%, on average.

ASLAN’s loss per share estimates have narrowed from 69 cents to 67 cents for 2019 and from 62 cents to 61 cents for 2020 in the past 90 days. The company delivered a positive earnings surprise in three of the trailing four quarters by 24.65%, on average.

Celsion’s loss per share estimates have narrowed from $1.00 to 94 cents for 2019 and from 77 cents to 66 cents for 2020 in the past 90 days. The company delivered a positive earnings surprise in three of the trailing four quarters by 51.11%, on average.

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