What: Shares of Alkermes (ALKS -1.64%), a global biopharmaceutical company developing therapies to treat a range of diseases and disorders, jumped as much as 11% after reporting positive top-line results from a late-stage study involving experimental intramuscular injection aripiprazole lauroxil for the treatment of schizophrenia. Shares have since cooled and are up less than 4% as of this writing.
So what: According to Alkermes' press release, patients taking the once-monthly treatment, either in a 441 mg or 882 mg dose, "demonstrated statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) total scores at week 12 compared to placebo." On top of meeting its primary endpoint, aripiprazole lauroxil also met its secondary endpoint of improvement from baseline in the Clinical Global Impression – Improvement Scale at week 12. Following this data, Alkermes is merely dotting its I's and crossing its T's in preparation for a new drug application filing next quarter. The press release also notes that the company will release its full phase 3 data on the drug at an upcoming medical conference.
Now what: It's always a bit tough to get too excited when you don't have the full data set in front of you, but as far as this is set to become an additional long-term injectable dosing option for schizophrenia patients this looks like a winner. The therapy was well-tolerated, safe, and it met both its primary and secondary endpoint, so I'm certainly leaning toward it having a better chance of being approved than rejected by the Food and Drug Administration at this point in time.
Alkermes itself is a really interesting case wherein a number of mid-cap and larger biopharmaceutical companies are moving their pipeline focus onto rare diseases, it's pushing back into the large chronic disease market. The company is profitable and it has a healthy and growing portfolio and pipeline. Long story short, I won't beat around the bush about recommending you get Alkermes on your watchlist and would suggest biotech-savvy investors dive more deeply into this company when they have the chance.
