Insys Therapeutics, Inc.NASDAQ
Insys Therapeutics Inc. Poised For Strong Growth In Earnings Ahead
Christopher Stoehr • 16 Comments
Christopher Stoehr • 16 Comments
Thu, Dec. 8, 4:13 PM
- Six former executives at Insys Therapeutics (INSY -11.9%) were arrested today on charges they orchestrated a scheme to bribe doctors to prescribe Subsys, a product containing the powerful opioid fentanyl, to non-cancer patients which was contrary to the product's labeling.
- Former CEO Michael Babich was among the group charged in the indictment filed in a Boston federal court. Also on the hook are ex-VP of Sales Alec Burlakoff, former national sales director Richard Simon, former sales directors Sunrise Lee and Joseph Rowan and former VP of managed markets Michael Gurry. Elizabeth Gurreiri, former reimbursement services manager, was arrested in October.
- Charges have also been filed in New York, Connecticut and Alabama against at least five former Insys employees. Illinois' AG sued the company in August following a $1.1M settlement in Oregon.
Mon, Nov. 7, 11:01 AM
Thu, Nov. 3, 7:04 AM
Wed, Nov. 2, 5:30 PM
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Tue, Oct. 18, 1:14 PM
- The U.S. District Court for the District of Massachusetts issued an arrest warrant last week for former Insys Therapeutics (INSY +6.7%) Reimbursement Services manager Elizabeth Gurrieri charging her with conspiracy to commit wire fraud. The charge stems from her activities managing prior payment authorizations related to Subsys (fentanyl sublingual spray). She allegedly instructed her group to intentionally mislead insurers and pharmacy benefit managers about patients' conditions in order to obtain authorizations for payment.
- A former sales manager was also arrested recently over charges of orchestrating illegal kickbacks to prescribers in order to drive sales of Subsys.
Tue, Oct. 18, 6:36 AM
Thu, Oct. 13, 7:14 AM
- On a preliminary basis, Insys Therapeutics (NASDAQ:INSY) expects Q3 revenues of $54M - 55M, based on anticipated Subsys sales. Based on the midpoint of $54.5M, revenues will be down over 40% yoy.
- The company believes it will be cash flow-positive at this level which will enable it to meet its product development and growth objectives.
Mon, Oct. 3, 12:29 PM
- Former Insys Therapeutics (INSY +4.9%) district sales manager Jeffery Perlman was arrested recently over charges of orchestrating illegal kickbacks to prescribers to goose sales of pain med Subsys (fentanyl sublingual spray). Mr. Perlman allegedly helped organize "educational" events at upscale restaurants featuring speakers who had experience with the drug.
- The speakers were paid fees of $1,000 and above for each event, but apparently didn't have to address the attendees. The events were merely social gatherings among friends and co-workers absent of any educational component. In order to disguise the events legitimate speaking programs, the sign-in sheets were forged, supposedly with Perlman's knowledge.
- A few months ago, Connecticut nurse Heather Alfonso pleaded guilty to accepting $83K in kickbacks from the company. She admitted that she prescribed Subsys to patients who were not suffering from cancer, the drug's approved indication. She is now a cooperating witness.
- Perlman worked at Insys from February 2013 to December 2015. Former CEO Michael Babich resigned in November 2015. Current chief Dr. John Kapoor announced his intention to leave several weeks ago as soon as a successor can be appointed.
- The company's dubious promotional practices were first exposed in an April 2015 by the Southern Investigative Reporting Foundation. A month later, two Mobile, AL-based pain specialists who were the top prescribers of Subsys were arrested on charges of illegal prescription drug distribution and conspiracy to commit healthcare fraud in order to increase insurance reimbursement.
- Previously: Insys Therapeutics off 17% on bearish article by investigative reporter (Dec. 3, 2015)
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