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Insys Therapeutics Inc (NASDAQ: INSY) announced the FDA approval of Syndros, and is waiting on a controlled substance designation from the Drug Enforcement Agency [DEA]. Piper Jaffray’s David Amsellem reiterated an Overweight rating on the company, with a price target of $28.
Syndros is an oral solution of dronabinol, or the cannabinoid THC, and received FDA approval for anorexia associated with weight loss in patients with AIDS, and chemotherapy-induced nausea and vomiting in patients who have failed conventional anti-emetics.
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Thoughts On DEA And Commercial Impact
Management had previously indicated that it expected a schedule II controlled substance designation for Syndros. “Recall that Marinol has a less restrictive schedule III designation, meaning that prescribers can write up to 5 refills (whereas no refills are permitted for a schedule II product),” analyst David Amsellem wrote.
The analyst believes a schedule II designation would not have a major commercial impact, since patients in these settings typically use dronabinol on an as-needed basis. The impact would have been higher if this were a chronic use product. Moreover, physicians in oncology supportive care are well-versed in prescribing schedule II products.
“Given these dynamics, and the fact that the product has meaningful differentiation vs. its predecessor (i.e., faster onset of action; no refrigeration needed), we believe that Syndros is well positioned to gain traction in the broader dronabinol market,” Amsellem stated. He also expressed optimism regarding a significant number of physicians who were not prescribing Marinol starting to prescribe Syndros.
Amsellem estimated peak sales of $300M-$400M+ and a long-term EPS CAGR of around 25-30 percent.
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New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.