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Kyowa Hakko Kirin Co Ltd (4151.T)

4151.T on Tokyo Stock Exchange

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Latest Key Developments (Source: Significant Developments)

Ultragenyx, Kyowa Kirin Say Crysvita Met Main Goal Of Phase 3 Study
Thursday, 17 May 2018 08:30am EDT 

May 17 (Reuters) - Ultragenyx Pharmaceutical Inc ::ULTRAGENYX AND KYOWA KIRIN ANNOUNCE TOPLINE PHASE 3 STUDY RESULTS DEMONSTRATING SUPERIORITY OF CRYSVITA® (BUROSUMAB) TREATMENT TO ORAL PHOSPHATE AND ACTIVE VITAMIN D IN CHILDREN WITH X-LINKED HYPOPHOSPHATEMIA (XLH).ULTRAGENYX PHARMACEUTICAL INC - PHASE 3 STUDY OF CRYSVITA® (BUROSUMAB) MET ITS PRIMARY ENDPOINT.ULTRAGENYX PHARMACEUTICAL - PHASE 3 STUDY OF CRYSVITA SHOWED IMPROVEMENT IN IMPORTANT METABOLIC AND FUNCTIONAL MEASURES WITH CRYSVITA TREATMENT.  Full Article

Mylan Says Non-Contingent Payments For 4 Agreements Total About $265 Mln
Thursday, 10 May 2018 05:59pm EDT 

May 10 (Reuters) - Kyowa Hakko Kirin Co Ltd <4151.T>::MYLAN NV - NON-CONTINGENT PAYMENTS FOR 4 AGREEMENTS, 3 OF WHICH WERE ENTERED INTO AFTER MARCH 31, 2018, TOTAL ABOUT $265.0 MILLION - SEC FILING.MYLAN-ON APRIL 9, A UNIT RECEIVED CIVIL INVESTIGATIVE DEMAND FROM COMMERCIAL LITIGATION BRANCH OF U.S. DOJ CONCERNING TAA COMPLIANCE FOR SOME PRODUCTS.MYLAN - ON APRIL 18, SOME EMPLOYEES OF MYLAN S.P.A. WERE SERVED WITH SEARCH WARRANTS ISSUED BY PUBLIC PROSECUTOR’S OFFICE IN MILAN, ITALY.MYLAN-WARRANTS BY MILAN PUBLIC PROSECUTOR’S OFFICE SEEK INFORMATION ON INTERACTIONS WITH ITALIAN HOSPITAL, SALES OF SOME REIMBURSABLE MYLAN S.P.A. DRUGS.  Full Article

Kyowa Kirin, Ultragenyx Announce Crysvita Receives Conditional Marketing Authorization In Europe For The Treatment Of X–Linked Hypophosphatemia In Children
Friday, 23 Feb 2018 08:00am EST 

Feb 23 (Reuters) - Ultragenyx Pharmaceutical Inc ::KYOWA KIRIN AND ULTRAGENYX ANNOUNCE CRYSVITA® (BUROSUMAB) RECEIVES CONDITIONAL MARKETING AUTHORIZATION IN EUROPE FOR THE TREATMENT OF X–LINKED HYPOPHOSPHATEMIA IN CHILDREN.ULTRAGENYX PHARMACEUTICAL - ‍FIRST COMMERCIAL LAUNCH OF CRYSVITA IS EXPECTED TO TAKE PLACE IN GERMANY IN Q2 OF 2018​.  Full Article

Kyowa Hakko Kirin appoints KPMG AZSA LLC as new corporate auditor
Wednesday, 21 Feb 2018 01:46am EST 

Feb 21 (Reuters) - Kyowa Hakko Kirin Co Ltd <4151.T>:Says it appoints KPMG AZSA LLC as new corporate auditor, to replace Ernst & Young ShinNihon LLC, effective March 23 .  Full Article

Kyowa Hakko Kirin sells 66.6 pct stake in unit Kyowa Medex
Thursday, 4 Jan 2018 01:40am EST 

Jan 4(Reuters) - Kyowa Hakko Kirin Co Ltd <4151.T>:Says it sold 66.6 percent stake in wholly owned unit Kyowa Medex Co., Ltd., to Hitachi Chemical Company, Ltd <<<4217.T>>>, on Jan. 4 .  Full Article

Kyowa Hakko Kirin says change of chairman and president
Friday, 22 Dec 2017 01:37am EST 

Dec 22 (Reuters) - Kyowa Hakko Kirin Co Ltd <4151.T> ::Says it appoints current president and CEO Nobuo Hanai as new chairman and CEO, Masashi Miyamoto as new president .Changes will be effective on the day of ordinary general meeting of shareholders scheduled in March 2018.  Full Article

Reata Pharmaceuticals- Entered Third Supplement To Exclusive License & Supply Agreement With Kyowa Hakko
Thursday, 7 Dec 2017 05:20pm EST 

Dec 7 (Reuters) - Kyowa Hakko Kirin Co Ltd <4151.T>::REATA PHARMACEUTICALS-ON DEC 7 CO ENTERED THIRD SUPPLEMENT TO EXCLUSIVE LICENSE & SUPPLY AGREEMENT, BY & BETWEEN CO, KYOWA HAKKO KIRIN CO LTD (KHK).REATA SAYS THIRD SUPPLEMENT ALLOWS CO TO BEGIN PORTION OF PHASE 3 CLINICAL STUDY OF RTA 402 IN FIELD OF ALPORT SYNDROME IN JAPAN - SEC FILING.REATA PHARMACEUTICALS - ON DEC 7 CO ENTERED FOURTH SUPPLEMENT TO EXCLUSIVE LICENSE & SUPPLY AGREEMENT, BY & BETWEEN CO & KHK.  Full Article

Kyowa Hakko Kirin Announces FDA Acceptance For Filing And Priority Review Designation Of Mogamulizumab's Biologics License Application
Tuesday, 28 Nov 2017 05:00am EST 

Nov 28 (Reuters) - Kyowa Hakko Kirin Co Ltd <4151.T>::KYOWA HAKKO KIRIN ANNOUNCES FDA ACCEPTANCE FOR FILING AND PRIORITY REVIEW DESIGNATION OF MOGAMULIZUMAB'S BIOLOGICS LICENSE APPLICATION.  Full Article

Kyowa Hakko Kirin says voluntary adoption of International Financial Reporting Standards (IFRS)
Thursday, 26 Oct 2017 03:13am EDT 

Oct 26 (Reuters) - Kyowa Hakko Kirin Co Ltd <4151.T>:Says it plans to adopt International Financial Reporting Standards (IFRS) as the new accounting method, to replace the Japanese Generally Accepted Accounting Principles .The change is to be implemented in its consolidated financial statements for the fiscal year ending December 31, 2017.  Full Article

ULTRAGENYX AND KYOWA HAKKO KIRIN ANNOUNCE FDA ACCEPTANCE OF BUROSUMAB’S BIOLOGICS LICENSE APPLICATION
Tuesday, 10 Oct 2017 08:30am EDT 

Oct 10 (Reuters) - Ultragenyx Pharmaceutical Inc ::ULTRAGENYX AND KYOWA HAKKO KIRIN ANNOUNCE FDA ACCEPTANCE AND PRIORITY REVIEW DESIGNATION OF BUROSUMAB’S BIOLOGICS LICENSE APPLICATION.ULTRAGENYX PHARMACEUTICAL INC - ‍PRESCRIPTION DRUG USER FEE ACT (PDUFA) ACTION DATE FOR BLA IS APRIL 17, 2018​.ULTRAGENYX PHARMACEUTICAL INC - FDA HAS NOT INFORMED COMPANIES WHETHER AN ADVISORY COMMITTEE MEETING TO DISCUSS APPLICATION WILL BE NEEDED​.ULTRAGENYX - FDA ACCEPTED BLA FOR BUROSUMAB TO TREAT PEDIATRIC, ADULT PATIENTS WITH X-LINKED HYPOPHOSPHATEMIA, GRANTED PRIORITY REVIEW STATUS​.  Full Article

BRIEF-Aevi Genomic Medicine Expands Collaboration With Kyowa Hakko Kirin Co

* AEVI GENOMIC MEDICINE INC - EXPANDED COLLABORATION WITH KYOWA HAKKO KIRIN CO LTD