Investors are showing interest in Insys Therapeutics’ newly announced US Food and Drug Administration designation as the company works to rebuild trust with its shareholders.
Investors are showing interest in Insys Therapeutics’ newly announced US Food and Drug Administration (FDA) designation as the company works to rebuilds trust with its shareholders.
On Thursday (August 30), Insys Therapeutics (NASDAQ:INSY) received notice from the FDA it has been given fast track designation for its epinephrine nasal spray as an investigational treatment for anaphylaxis—a potential game-changer for the long-lived EpiPen.
“We look forward to working with the agency to make it available to those who may be interested in an alternative to intramuscular auto-injectors as soon as possible,” Steve Sherman, senior vice president of regulatory affairs at Insys, said in the press release.
In early August, Insys announced it had settled the opioid lawsuit with the US Department of Justice for US$150 million. According to the company’s management team, there is the potential for additional payments up to US$75 million.
Although Insys has since let go of the main players which illegally pushed its opioid-based product, Subsys—which has contributed to the opioid crisis—the company must now amend bridge of trust with investors.
Insys is now focusing on its spray epinephrine technology. The product is currently in development for allergy sufferers who experience anaphylaxis. It brings the potential for a needle-free, non-invasive and simplified option to the EpiPen.
A previous clinical trial published findings in mid-June 2018, demonstrating that the product showcased rapid drug absorption. According to the study, this is necessary for patients undergoing anaphylaxis.
In the US, over 200,000 anaphylaxis take place on an annual basis while up to 150 million people around the world may experience it at some point in their lives.
Insys has three other sprays in its pipeline currently in development, including sublingual, nasal and cannabinoid products. Insys is going from a different angle with its developmental spray pipeline, finding different methods to deliver novel drugs such as naloxone, buprenorphine and more.
The company hopes to use this differentiated method of delivery to meet the shortcomings of products already on the market.
Indications for the sprays include moderate-to-severe acute pain, opioid dependence and opioid overdose. Childhood absence epilepsy, anorexia from cancer are some initial treatment opportunities for the cannabinoid product candidates.
Insys has also reported fast track designation for its cannabidiol oral solution for Prader-Willi syndrome, which is currently in its Phase 2 stage of development.
In early trading on Thursday, Insys’ share price increased as high as 45 percent, but settled at a 34.05 percent increase over the one day-trading period to close at US$10.67.
Over the last month, analysts have released split consensus on the company, with two rating the company as a a “Buy” a with one ranking the company as a “Sell.” Price targets from the analysts range from US$4 to US$10.
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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.