Edition:
United Kingdom

INSYS Therapeutics Inc (INSY.OQ)

INSY.OQ on NASDAQ Stock Exchange Global Market

9.15USD
21 Sep 2018
Change (% chg)

$-0.30 (-3.17%)
Prev Close
$9.45
Open
$9.49
Day's High
$9.66
Day's Low
$9.03
Volume
279,410
Avg. Vol
159,233
52-wk High
$14.00
52-wk Low
$4.10

Latest Key Developments (Source: Significant Developments)

FDA Grants Insys Therapeutics ‘Fast Track’ Designation For Epinephrine Nasal Spray As Investigational Treatment For Anaphylaxis
Thursday, 30 Aug 2018 

Aug 30 (Reuters) - INSYS Therapeutics Inc ::FDA GRANTS INSYS THERAPEUTICS ‘FAST TRACK’ DESIGNATION FOR EPINEPHRINE NASAL SPRAY AS INVESTIGATIONAL TREATMENT FOR ANAPHYLAXIS.  Full Article

Insys Therapeutics Q2 Adj Shr Loss $0.33
Wednesday, 8 Aug 2018 

Aug 8 (Reuters) - INSYS Therapeutics Inc ::INSYS THERAPEUTICS REPORTS SECOND QUARTER 2018 RESULTS.Q2 NET REVENUE $23.5 MILLION VERSUS $42.6 MILLION.Q2 LOSS PER SHARE $0.37.Q2 ADJUSTED LOSS PER SHARE $0.33.BELIEVE WE REMAIN ON TRACK TO SUBMIT AN NDA FOR NALOXONE NASAL SPRAY BY END OF 2018.Q2 REVENUE VIEW $25.9 MILLION -- THOMSON REUTERS I/B/E/S.Q2 EARNINGS PER SHARE VIEW $-0.16 -- THOMSON REUTERS I/B/E/S.  Full Article

Insys Therapeutics Q2 Loss Per Share $0.37
Wednesday, 8 Aug 2018 

INSYS Therapeutics Inc ::INSYS THERAPEUTICS REPORTS SECOND QUARTER 2018 RESULTS.Q2 LOSS PER SHARE $0.37.Q2 REVENUE $38 MILLION VERSUS $58.2 MILLION.Q2 REVENUE VIEW $25.9 MILLION -- THOMSON REUTERS I/B/E/S.Q2 EARNINGS PER SHARE VIEW $-0.16 -- THOMSON REUTERS I/B/E/S.Q2 ADJUSTED LOSS PER SHARE $0.33.BELIEVE WE REMAIN ON TRACK TO SUBMIT AN NDA FOR NALOXONE NASAL SPRAY BY END OF 2018.  Full Article

Insys Therapeutics Reaches Agreement In Principle To Settle DOJ Investigation
Wednesday, 8 Aug 2018 

Aug 8 (Reuters) - INSYS Therapeutics Inc ::INSYS THERAPEUTICS REACHES AGREEMENT IN PRINCIPLE TO SETTLE DEPARTMENT OF JUSTICE INVESTIGATION.INSYS THERAPEUTICS INC - INSYS ALSO EXPECTS THAT A FINAL SETTLEMENT WOULD INCLUDE OTHER MATERIAL NON-FINANCIAL TERMS.INSYS - AGREEMENT IN PRINCIPLE TO SETTLE CIVIL AND CRIMINAL INVESTIGATION INTO INAPPROPRIATE SALES, COMMERCIAL PRACTICES BY SOME FORMER CO EMPLOYEES.INSYS - CONSISTENT WITH PREVIOUS PUBLIC STATEMENTS & DISCLOSURES, TERMS OF AGREEMENT IN PRINCIPLE CALL FOR CO TO PAY $150 MILLION OVER 5 YRS.  Full Article

Insys Therapeutics Receives Complete Response Letter From FDA For Buprenorphine NDA
Friday, 27 Jul 2018 

INSYS Therapeutics Inc ::INSYS THERAPEUTICS RECEIVES COMPLETE RESPONSE LETTER FROM FDA FOR BUPRENORPHINE NDA.INSYS THERAPEUTICS - CRL INDICATES THAT SOME BUPRENORPHINE NDA DATA SUGGESTED POTENTIAL SAFETY CONCERNS.  Full Article

Insys Therapeutics Responds To Unsealing Of Previously Filed Qui Tam Complaints
Tuesday, 15 May 2018 

May 15 (Reuters) - INSYS Therapeutics Inc ::INSYS THERAPEUTICS RESPONDS TO UNSEALING OF PREVIOUSLY FILED QUI TAM COMPLAINTS AND RECAPS TRANSFORMATION EFFORTS.INSYS THERAPEUTICS - ONGOING DIALOGUE WITH DOJ HAS NOT RESULTED IN INFORMATION THAT WOULD CAUSE CO TO REVISE ESTIMATE OF MINIMUM LIABILITY EXPOSURE.INSYS THERAPEUTICS SAYS CONTINUES TO HAVE ONGOING DIALOGUE WITH U.S. DOJ REGARDING INVESTIGATION THAT IN DEC 2013 WAS COMMENCED BY DOJ'S CIVIL DIVISION.  Full Article

Insys Therapeutics Announces Exclusive License Partnership To Commercialize Subsys In Middle East
Tuesday, 8 May 2018 

May 8 (Reuters) - INSYS Therapeutics Inc ::INSYS THERAPEUTICS ANNOUNCES EXCLUSIVE LICENSE PARTNERSHIP WITH LUNATUS TO COMMERCIALIZE SUBSYS® (FENTANYL SUBLINGUAL SPRAY) IN THE MIDDLE EAST.INSYS - CO'S RESPONSIBILITIES WILL INCLUDE SUPPLYING SUBSYS TO LUNATUS, WHOSE RESPONSIBILITIES WILL INCLUDE OBTAINING APPROVALS TO COMMERCIALIZE SUBSYS.INSYS - LUNATUS WILL BE EXCLUSIVE LICENSEE FOR SUBSYS IN BAHRAIN, JORDAN, KUWAIT, LEBANON, OMAN, QATAR, SAUDI ARABIA AND UNITED ARAB EMIRATES.  Full Article

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

UPDATE 2-Maryland charges Insys with engaging in deceptive opioid scheme

Sept 6 Maryland on Thursday charged Insys Therapeutics Inc with deceptively marketing a powerful opioid pain killer so that it was prescribed inappropriately beyond its intended use with cancer patients.