What happened
After management announced a compassionate-use program so that patients could continue getting its cannabidiol epilepsy drug, Insys Therapeutics' (INSY) shares shot 27% higher in February, according to S&P Global Market Intelligence.
So what
Insys Therapeutics has been struggling to overcome backlash stemming from allegations and the arrest of former executives who have been accused for illegally marketing the company's opioid pain medicine, Subsys.
IMAGE SOURCE: GETTY IMAGES.
Subsys is approved for use in breakthrough cancer pain; however, investigations into prescribing activity have led to the arrest of the company's former CEO, Michael Babich, on charges of providing kickbacks for prescriptions in unapproved indications.
The Subsys saga has led to questions regarding the company's focus. Specifically, up until last month, there's been little news regarding the development progress of Insys Therapeutics' marijuana-based epilepsy program. The company is evaluating the use of a chemical cannabinoid, cannabidiol (CBD), in patients with tough-to-treat childhood forms of epilepsy.
Management's disclosure that it has begun a compassionate-use program to allow patients who were participating in a 48-week safety study for CBD, therefore, came as much-welcomed news.
Now what
It remains to be seen if the news is too little, too late, and the company continues to be mired in uncertainty given that interim CEO and founder Dr. John Kapoor stepped down last month.
Competitor GW Pharmaceuticals (GWPH) has already reported data from three separate trials showing that its CBD-based drug, Epidiolex, can reduce monthly seizures in childhood epilepsy by about 40%. Those findings put GW Pharmceuticals on track to file for FDA approval this year. Based on that timeline, the FDA could grant Epidiolex a green light in 2018, giving it a big head start over Insys Therapeutics.
Insys Therapeutics also continues to wrestle with its Subsys overhang and a C-suite turnstile. The departure of Kapoor was expected, but it still raises questions for investors regarding leadership, and it still remains to be seen if Insys Therapeutics will face fines or penalties associated with Subsys.
With question marks remaining, it's hard to get too excited about Insys Therapeutics creating a compassionate-use program for its marijuana medicine. Investors are probably best off waiting on the sidelines for actual safety or efficacy data and clarity into management's plans regarding its marijuana program before buying. Instead, it might be better to focus on other stock ideas.
