4 Drug Stocks With Major FDA Decisions Coming This Month
April 3, 2017
By Mark Terry, BioSpace.com Breaking News Staff
April is well known for being tax-paying month. But for four biotech companies, April is the month where their stocks might take a big jump—or the reverse—because of important catalysts. Keith Speights, writing for The Motley Fool, takes a look.
1. Neurocrine Biosciences
Based in San Diego, Calif., Neurocrine Biosciences focuses on neurological and endocrine-based diseases. The company’s Ingrezza for tardive dyskinesia will have a decision by the U.S. Food and Drug Administration (FDA) by April 11.
Tardive dyskinesia patients have involuntary, repetitive movements of the face, trunk or extremities. There is no approved treatment.
Speights notes, “Neurocrine experienced a disappointment with Ingrezza earlier this year when the drug failed to meet the primary endpoint in a Phase II clinical study targeting adults with Tourette syndrome. The biotech has another Phase II study under way evaluating Ingrezza in treating pediatric Tourette syndrome.”
Neurocrine is currently trading for $44.20.
2. Incyte and 3. Eli Lilly
There have been numerous rumors that Gilead has plans to buy Incyte , and in mid-March, the rumors came back, causing the company’s stock to jump. If that happens, if it was more than rumors, expect Incyte stock to continue to climb. The company has two products on the market, Jakafi and Iclusig.
In this case, Incyte and Eli Lilly are expecting the FDA to make a decision on baricitinib for rheumatoid arthritis by April 14. It was originally scheduled to make a decision in January 2017, but the FDA wanted more time to review the data. Incyte developed the drug, but licensed it to Lilly in 2009. It is being evaluated in psoriatic arthritis, atopic dermatitis, and systemic lupus erythematosus.
Speights write, “Does the delay hint at problems? Not necessarily. Baricitinib looked great in late-stage clinical studies, even beating top-selling rheumatoid arthritis drug Humira in a head-to-head comparison. Also, the drug already won European approval in February.”
Incyte is currently trading for $139.67.
Eli Lilly is currently trading for $84.56.
4. BioMarin Pharmaceutical
Based in San Rafael, Calif., BioMarin Pharmaceutical has five drugs on the market for rare diseases. They are Vimizim for Morquio A Syndrome; Kuvan for phenylketonuria (PKU); Naglazyme for mucopolysaccharidosis (MPS) VI, Aldurazyme for MPS I; and Firdapse for Lambert-Eaton Myasthenic Syndrome (LEMS).
The FDA should make a decision on the company’s Brineura for CLN2 disease by April 27. CLN2 is a type of Batten disease, which usually is diagnosed in children between the ages of two and four. It includes language delay and seizures, which then are followed by movement disorders, motor deterioration, dementia, and blindness. Patients typically die between the ages of 10 and 16. There are no approved treatments.
Speights writes, “Late-stage study results showed significant improvement in the rate of clinical decline for children receiving Brineura. Even incremental improvement can mean the difference between children being able to walk and talk—or not. It’s impossible to know for sure what the FDA will do, but I expect there will be a firestorm from Batten disease patient advocates if the agency doesn’t approve Brineura.”
BioMarin Pharmaceutical is currently trading for $87.93.