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INSYS Therapeutics Inc (INSY.OQ)

INSY.OQ on NASDAQ Stock Exchange Global Market

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16 Jan 2018
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Latest Key Developments (Source: Significant Developments)

Insys' Treatment For Prader-Willi Syndrome Gets ‘Fast Track’ Designation
Tuesday, 26 Dec 2017 

Dec 26 (Reuters) - Insys Therapeutics Inc ::FDA GRANTS INSYS THERAPEUTICS ‘FAST TRACK’ DESIGNATION FOR CANNABIDIOL (CBD) ORAL SOLUTION AS INVESTIGATIONAL TREATMENT FOR PRADER-WILLI SYNDROME.INSYS THERAPEUTICS - PLAN TO START CLINICAL DEVELOPMENT PROGRAM FOR CANNABIDIOL ORAL SOLUTION IN LATE Q1 OF 2018.  Full Article

Insys Therapeutics Inc - ‍Study Is Expected To Be Completed In Late 2018 For Of Cbd Oral Solution-A​
Tuesday, 19 Dec 2017 

Dec 19 (Reuters) - Insys Therapeutics Inc ::INSYS THERAPEUTICS INITIATES PHASE 2 CLINICAL TRIAL OF CANNABIDIOL (CBD) ORAL SOLUTION FOR TREATMENT OF REFRACTORY CHILDHOOD ABSENCE EPILEPSY IN PEDIATRIC PATIENTS.INSYS THERAPEUTICS INC - ‍STUDY IS EXPECTED TO BE COMPLETED IN LATE 2018 FOR OF CBD ORAL SOLUTION-A​.  Full Article

Insys Therapeutics' NDA For Buprenorphine Sublingual Spray Accepted By FDA
Wednesday, 6 Dec 2017 

Dec 6 (Reuters) - Insys Therapeutics Inc ::FDA ACCEPTS NEW DRUG APPLICATION (NDA) FOR BUPRENORPHINE SUBLINGUAL SPRAY FROM INSYS THERAPEUTICS.SAYS ‍UNDER PDUFA, FDA HAS SET TARGET DATE OF JULY 28, 2018 TO COMPLETE REVIEW OF NDA FOR BUPRENORPHINE SUBLINGUAL SPRAY​.SAYS ‍DATA FROM RECENTLY COMPLETED 7-DAY SAFETY & TOLERABILITY STUDY TO BE SUBMITTED TO FDA IN Q1 2018, MAY IMPACT PDUFA DATE​.  Full Article

Insys Therapeutics reports Q3 loss per share of $2.30
Thursday, 2 Nov 2017 

Nov 2 (Reuters) - Insys Therapeutics Inc :Insys therapeutics reports third quarter 2017 results.Q3 loss per share $2.30.Q3 revenue $48.9 million.Q3 revenue view $35.5 million -- Thomson Reuters I/B/E/S.Q3 earnings per share view $-0.16 -- Thomson Reuters I/B/E/S.Insys therapeutics inc qtrly ‍net revenue was unfavorably impacted by approximately $5 million due to product returns​.Insys therapeutics inc qtrly ‍ gross revenue was $48.9 million, resulting in net revenue of $30.7 million​.  Full Article

Insys Therapeutics provides update on NASDAQ trading hold
Monday, 30 Oct 2017 

Oct 30 (Reuters) - Insys Therapeutics Inc ::Insys Therapeutics provides update on NASDAQ trading hold.Subsequent to trading hold placed on stock on Thursday after market close, received series of questions on Friday from NASDAQ​.Questions received from NASDAQ on Oct 27 have been addressed, co is awaiting response from NASDAQ regarding resumption of trading​.  Full Article

Insys Therapeutics replaces 90 pct of original sales force
Friday, 6 Oct 2017 

Oct 6 (Reuters) - Insys Therapeutics Inc : :Insys Therapeutics addresses New Jersey complaint.Insys Therapeutics inc - ‍company is under new management and has replaced 90 percent of original sales force and commercial organization​.Insys Therapeutics says it continues to work with relevant authorities to resolve issues related to inappropriate actions taken by some of co's former employees​.‍Accordingly, co has taken "a series of major actions to prevent mistakes of past from happening in future​".  Full Article

Insys Therapeutics files new drug application for buprenorphine sublingual spray
Friday, 29 Sep 2017 

Sept 29 (Reuters) - Insys Therapeutics Inc :Insys Therapeutics files new drug application (NDA) for buprenorphine sublingual spray with FDA.  Full Article

Insys addresses Arizona Attorney General complaint
Friday, 1 Sep 2017 

Sept 1 (Reuters) - Insys Therapeutics Inc ::Insys addresses Arizona Attorney General complaint.Says continue to cooperate with investigation by Arizona Attorney General Office.Says ‍allegations in Arizona AG's complaint relate to former employees, physicians that are no longer associated with co/its speaker bureau​.  Full Article

Insys Therapeutics Q2 loss per share $0.11
Thursday, 3 Aug 2017 

Aug 3 (Reuters) - Insys Therapeutics Inc :Insys Therapeutics reports second quarter 2017 results.Q2 adjusted non-gaap earnings per share $0.03.Q2 loss per share $0.11.Q2 revenue $42.6 million versus i/b/e/s view $36.8 million.Q2 earnings per share view $-0.11 -- Thomson Reuters I/B/E/S.Insys Therapeutics Inc- ‍charges related to litigation award and government settlements were $4.5 million for q2 of 2017​.Insys Therapeutics Inc says expect to file at least one new drug application with FDA each year for next five years.Appointed Andrew G. Long as chief financial officer.  Full Article

Insys announces availability of Syndros by prescription
Monday, 31 Jul 2017 

July 31 (Reuters) - Insys Therapeutics Inc :Insys announces availability of Syndros, the first and only FDA-approved liquid dronabinol, by prescription.Insys Therapeutics Inc - Syndros is now available for health care professionals to prescribe.  Full Article

Ex-Insys employee seeks ban on mentioning 'opioid crisis' at trial

Jan 11 A former Insys Therapeutics Inc employee accused of engaging in a scheme to pay medical practitioners kickbacks to prescribe a fentanyl-based treatment is seeking to bar U.S. prosecutors from referring to the "opioid crisis" at his trial.