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INSYS Therapeutics Inc (INSY.OQ)

INSY.OQ on NASDAQ Stock Exchange Global Market

15.95USD
22 Jul 2016
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Latest Key Developments (Source: Significant Developments)

Insys Therapeutics announces FDA approval of Syndros
Tuesday, 5 Jul 2016 06:55am EDT 

Insys Therapeutics Inc : Syndros is currently awaiting scheduling by U.S. Drug Enforcement Administration . Company anticipates launching Syndros in second half of 2016 . Syndros is approved for use in treating anorexia associated with weight loss in patients with AIDS . Insys therapeutics announces FDA approval of Syndros .Syndros is also approved for use in treating nausea, vomiting associated cancer chemotherapy in patients.  Full Article

Kessler Topaz Meltzer & Check, LLP Files Shareholder Class Action Against Insys Therapeutics Inc - ACSWIR
Saturday, 6 Feb 2016 12:01am EST 

Insys Therapeutics Inc:The law firm of Kessler Topaz Meltzer & Check, LLP announces that it has filed a shareholder class action lawsuit against Insys Therapeutics on behalf of purchasers of the Company's securitiesbetween March 3, 2015 and January 25, 2016 - ACSWIR.The shareholder class action complaint alleges that Insys and certain of its executive officers made a series of false and misleading statements, and failed to disclose material adverse facts, about the Company's business and operations to investors during the Class Period.Specifically, the defendants are alleged to have failed to disclose that the Company was engaged in the illegal and improper off-labeling marketing of Subsys;.certain Insys employees - including Defendant Michael L. Babich, the President and Chief Executive Officer of Insys during much of the Class Period - were complicit in an illegal kickback scheme operated for the purpose of increasing prescriptions of Subsys.as a result, the Company's financial statements were materially false and misleading at all relevant times.  Full Article

Insys Therapeutics Inc announces stock repurchase program
Thursday, 5 Nov 2015 06:52am EST 

Insys Therapeutics Inc:Has approved the repurchase of up to $50 million of the Company's common stock.Intends to finance the share repurchase program through available cash and cash equivalents on hand.  Full Article

Insys Therapeutics Inc says John Kapoor appointed CEO
Thursday, 5 Nov 2015 06:51am EST 

Insys Therapeutics Inc:Says Michael L. Babich has stepped down as President and Chief Executive Officer of Insys.Says appoints John N. Kapoor as President and Chief Executive Officer effective November 4, 2015.Says Kapoor will continue to serve of the Chairman of the Company's Board of Directors.  Full Article

Insys Therapeutics announces naloxone sublingual spray received fast track designation from the FDA for treatment of opioid intoxication or overdose
Thursday, 29 Oct 2015 03:03pm EDT 

Insys Therapeutics Inc:Announced that the U.S. Food and Drug Administration has granted Fast Track designation to its Naloxone Sublingual Spray for the treatment of known or suspected opioid intoxication or overdose.  Full Article

Insys Therapeutics Inc Submits to the FDA the New Drug Application for Dronabinol Oral Solution
Thursday, 6 Aug 2015 07:00am EDT 

Insys Therapeutics Inc:Submits to the U.S. Food and Drug Administration (FDA) the New Drug Application (NDA).Says this is for Dronabinol Oral Solution for anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.  Full Article

Insys Therapeutics Inc receives FDA orphan drug designation for its Pharmaceutical Cannabidiol for treatment of infantile spasms
Tuesday, 4 Aug 2015 08:00am EDT 

Insys Therapeutics Inc:Says U.S FDA has granted orphan drug designation to its pharmaceutical cannabidiol (CBD) candidate for treatment of infantile spasms (IS).  Full Article

Insys Therapeutics submits NDA for dronabinol oral solution
Tuesday, 2 Jun 2015 07:00am EDT 

Insys Therapeutics:Submits nda for dronabinol oral solution.Says expects the current nda contains all information required to permit a substantive review by the FDA.  Full Article

Insys Therapeutics Inc announces its pharmaceutical cannabidiol received fast track designation from FDA
Thursday, 26 Feb 2015 07:00am EST 

Insys Therapeutics Inc:Says U.S. Food and Drug Administration has granted fast track designation to its pharmaceutical cannabidiol formulation for treatment of dravet syndrome, a rare form of childhood epilepsy.Says drug development program with fast track designation is afforded greater access to FDA for purpose of expediting the drug's development, review and potential approval to get important new drugs to patient earlier.  Full Article

Insys Therapeutics Inc enters into exclusive sub-license agreement with Gold Coast Therapeutics
Tuesday, 24 Feb 2015 07:00am EST 

Insys Therapeutics Inc:Enters into exclusive sub-license agreement with Gold Coast Therapeutics to develop a unique combination of cromolyn sodium and cetirizine as a new chemical entity for the treatment of chronic prostatitis/chronic pelvic pain syndrome, or CP/CPPS.  Full Article

BRIEF-Insys Therapeutics announces FDA approval of Syndros

* Syndros is currently awaiting scheduling by U.S. Drug Enforcement Administration