Insys Therapeutics Inc. Poised For Strong Growth In Earnings Ahead
Christopher Stoehr • 16 Comments
Christopher Stoehr • 16 Comments
Wed, Sep. 21, 11:15 AM
- Insys Therapeutics (INSY -5.5%) President & CEO Dr. John Kapoor has decided to leave the company to pursue "outside interests." He will remain on board until his replacement is appointed. The search for a successor has been initiated.
- The stock has been in a long-term downtrend since last year. Shares bottomed at $11.45 on June 27, down ~75% from July 2015 before reversing. Last month, the company reported positive results from a Phase 3 study of pain candidate Buprenorphine Sublingual Spray. It plans to meet with the FDA by year end to clarify the requirements for a New Drug Application (NDA).
- Previously: Insys' Buprenorphine Sublingual Spray successful in late-stage study; shares up 9% premarket (Aug. 24)
Tue, Sep. 20, 4:46 PM
- via Bespoke - see table
- Five of the stocks have > 50% of their shares sold short.
- SHLD leads the pack.
Fri, Sep. 9, 11:00 AM
Wed, Sep. 7, 3:32 PM
- GW Pharmaceuticals (GWPH +20.6%) is up on more than double normal volume amidst rumors that it is working with an investment bank after unnamed companies contacted it about a possible transaction.
- The company's lead product candidate is Phase 3-stage Epidiolex (cannabidiol) in development for the treatment of certain kinds of epilepsy, infantile spasms and tuberous sclerosis complex. A U.S. marketing application is on tap for H1 2017 for Lennox-Gastaut syndrome and Dravet syndrome, two forms of childhood epilepsy.
- Fellow cannabidiol developers Insys Therapeutics (INSY +4.8%) and Zynerba Pharmaceuticals (ZYNE +9%) are also up. Insys' candidate is in development for the treatment of cocaine dependence. Zynerba's (ZYN002) is a topical gel formulation for the potential treatment of knee pain due to arthritis and Fragile X syndrome.
Wed, Aug. 24, 9:14 AM
Wed, Aug. 24, 9:04 AM
- Insys Therapeutics (NASDAQ:INSY) is ahead 9% premarket on increased volume in response to its announcement of successful results in its Phase 3 study assessing Buprenorphine Sublingual Spray for the treatment of moderate-to-severe postoperative pain in patients undergoing bunionectomy, a procedure that requires an incision on the top or side of the big toe joint.
- The primary endpoint was the summed pain intensity difference over 48 hours. The three dosages of Buprenorphine evaluated (0.5 mg 3x/day, 0.25 mg 3x/day, 0.125 mg 3x/day) were all statistically significantly better than placebo with the highest dose showing the largest reduction (expected for a pain medication).
- The company plans to discuss the results with the FDA by year end as well as the steps required to file a New Drug Application (NDA).
- Update: Slingshot Insights has a proposed expert interview to better understand these results as well as Recro Pharma's (NASDAQ:REPH) late-stage data on IV meloxicam. Astute investors will want to participate.
Thu, Aug. 18, 8:13 AM
- The first patient has been enrolled in a Phase 2 study assessing Insys Therapeutics' (NASDAQ:INSY) pharmaceutical cannabidiol candidate for the treatment of cocaine dependence.
- Target enrollment is 110 subjects. The primary endpoint is drug-cue-induced craving at Day 8 as measured by a 10-point visual analog scale (VAS). Secondary endpoints are stress-induced craving at Day 8, cocaine use during the post-detoxification phase and the number of days to relapse.
- According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is December 2018. The estimated study completion date is December 2019.
Thu, Aug. 11, 11:56 AM
Wed, Aug. 3, 9:41 AM
Wed, Aug. 3, 6:52 AM
Tue, Aug. 2, 5:30 PM
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Fri, Jul. 15, 5:38 PM
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Tue, Jul. 5, 8:39 AM
- Insys Therapeutics (NASDAQ:INSY) is up 21% premarket on robust volume in response to its announcement that the FDA has approved its dronabinol oral solution, Syndros, for the treatment of anorexia-associated weight loss in patients with AIDS and the treatment of chemotherapy-induced nausea and vomiting (CINV) in patients who have not responded to conventional antiemetic treatments.
- It is the first dronabinol solution approved in the U.S.
- Syndros is a liquid formulation of the pharmaceutical cannabinoid, dronabinol, a synthetic version of tetrahydrocannabinol (THC). It is awaiting scheduling by the U.S. Drug Enforcement Administration.
- Read now Insys Therapeutics Is Hoping Syndros Is Its Blockbuster Marijuana Ticket