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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)

FDA Approves Poteligeo Injection For Treatment Of Mycosis Fungoides And Sézary Syndrome
Wednesday, 8 Aug 2018 

Aug 8 (Reuters) - U.S. Food and Drug Administration:U.S. FDA - APPROVED POTELIGEO INJECTION FOR TREATING ADULTS WITH RELAPSED/REFRACTORY MYCOSIS FUNGOIDES OR SÉZARY SYNDROME AFTER AT LEAST 1 PRIOR SYSTEMIC THERAPY.U.S. FDA SAYS GRANTED APPROVAL FOR TREATMENT FOR TWO RARE TYPES OF NON-HODGKIN LYMPHOMA TO KYOWA KIRIN, INC.  Full Article

Kyowa Kirin Announces FDA Approval Of Poteligeo For Treatment Of Mycosis Fungoides & Sézary Syndrome
Wednesday, 8 Aug 2018 

Aug 8 (Reuters) - Kyowa Hakko Kirin Co Ltd <4151.T>::KYOWA KIRIN ANNOUNCES FDA APPROVAL OF POTELIGEO® (MOGAMULIZUMAB-KPKC) FOR THE TREATMENT OF MYCOSIS FUNGOIDES AND SÉZARY SYNDROME.KYOWA HAKKO KIRIN SAYS KYOWA KIRIN INTERNATIONAL PLC WILL BE RESPONSIBLE FOR COMMERCIALIZING POTELIGEO IN U.S. & THIS IS PLANNED TO COMMENCE IN Q4 2018.  Full Article

Kyowa Hakko Kirin sells 66.6 pct stake in unit Kyowa Medex
Thursday, 4 Jan 2018 

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 

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
Friday, 8 Dec 2017 

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 

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 

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 

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