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Loxo Oncology Inc (LOXO.OQ)

LOXO.OQ on NASDAQ Stock Exchange Global Market

140.00USD
13 Dec 2018
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Latest Key Developments (Source: Significant Developments)

Bayer Says Response To FDA Warning Letter Going According To Plan
Tuesday, 13 Nov 2018 04:15am EST 

Nov 13 (Reuters) - Bayer ::CEO SAYS RESPONSE TO FDA WARNING LETTER GOING ACCORDING TO PLAN, EXPECTS RE-INSPECTION BY FDA IN 2019.CEO SAYS EXPECT SLIGHT GROWTH IN AGRICULTURE INDUSTRY THIS YEAR.CEO SAYS WE WILL LIKELY HAVE TO DEAL WITH GLYPHOSATE LITIGATION BEYOND 2021.CEO SAYS BURDEN DUE TO FDA WARNING LETTER WAS MID-DOUBLE DIGIT MILLION EURO AMOUNT IN Q3.CEO SAYS MORE EXTERNAL DRUG DEVELOPMENT DEALS POSSIBLE IN ORDER OF MAGNITUDE OF DEAL WITH LOXO ONCOLOGY.  Full Article

Loxo Oncology Qtrly Loss Per Share $0.89
Thursday, 8 Nov 2018 06:45am EST 

Nov 8 (Reuters) - Loxo Oncology Inc ::LOXO ONCOLOGY REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS.LOXO ONCOLOGY INC - QTRLY LOSS PER SHARE $0.89.LOXO ONCOLOGY INC - REVENUE FROM THE COLLABORATION AGREEMENT WAS $42.5 MILLION FOR Q3 OF 2018, COMPARED TO NONE FOR THE Q3 OF 2017.  Full Article

Loxo Oncology Announces Receipt Of Breakthrough Therapy Designation For LOXO-292
Monday, 15 Oct 2018 06:45am EDT 

Oct 15 (Reuters) - Loxo Oncology Inc ::LOXO ONCOLOGY ANNOUNCES RECEIPT OF BREAKTHROUGH THERAPY DESIGNATION FROM U.S. FOOD AND DRUG ADMINISTRATION FOR LOXO-292 FOR THE TREATMENT OF RET FUSION-POSITIVE THYROID CANCER.  Full Article

Bayer Says U.S. FDA Accepts Larotrectinib New Drug Application
Tuesday, 29 May 2018 06:49am EDT 

May 29 (Reuters) - Bayer ::SAYS U.S. FDA ACCEPTS LAROTRECTINIB NEW DRUG APPLICATION AND GRANTS PRIORITY REVIEW.SAYS U.S. FDA GRANTED PRIORITY REVIEW FOR LAROTRECTINIB FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS.  Full Article

FDA Accepts Larotrectinib New Drug Application And Grants Priority Review
Tuesday, 29 May 2018 06:45am EDT 

May 29 (Reuters) - Loxo Oncology Inc ::FDA ACCEPTS LAROTRECTINIB NEW DRUG APPLICATION AND GRANTS PRIORITY REVIEW.LOXO ONCOLOGY INC - PDUFA DATE SET FOR NOVEMBER 26, 2018 FOR LAROTRECTINIB.LOXO ONCOLOGY INC - LAROTRECTINIB HAS ALSO BEEN GRANTED BREAKTHROUGH THERAPY DESIGNATION.LOXO ONCOLOGY INC - BAYER PLANS TO SUBMIT A MARKETING AUTHORIZATION APPLICATION (MAA) IN EUROPEAN UNION IN 2018.  Full Article

Loxo Oncology Reports Quarterly Non-Gaap Net Loss Per Share $1.24
Thursday, 1 Mar 2018 06:45am EST 

March 1 (Reuters) - Loxo Oncology Inc ::LOXO ONCOLOGY REPORTS FOURTH QUARTER AND YEAR-END 2017 FINANCIAL RESULTS.‍LAROTRECTINIB ROLLING NDA SUBMISSION ON TRACK FOR COMPLETION IN MARCH​.‍LOXO-292 PHASE 1 CLINICAL DATA UPDATE EXPECTED IN FIRST HALF 2018​.‍ REVENUE FROM COLLABORATION AGREEMENT WAS $21.3 MILLION FOR Q4 COMPARED TO NONE FOR Q4 2016​.INITIATION OF PHASE 1 CLINICAL TRIAL FOR LOXO-305 (BTK) IS EXPECTED IN SECOND HALF OF 2018.QTRLY NET LOSS PER SHARE OF COMMON STOCK, BASIC AND DILUTED $0.69‍​.QUARTERLY NON-GAAP NET LOSS PER SHARE $1.24.Q4 EARNINGS PER SHARE VIEW $-1.13 -- THOMSON REUTERS I/B/E/S.  Full Article

Bayer Announces Initiation Of Rolling Submission Of NDA In U.S. For Larotrectinib
Wednesday, 20 Dec 2017 06:49am EST 

Dec 20 (Reuters) - BAYER AG ::INITIATION OF ROLLING SUBMISSION OF NDA IN U.S. FOR LAROTRECTINIB FOR TREATMENT OF TRK FUSION CANCERS​.‍COMPLETION OF NDA SUBMISSION EXPECTED IN EARLY 2018​.  Full Article

Loxo Oncology Initiates Rolling Submission Of NDA To U.S. FDA For TRK Fusion Cancers Treatment
Wednesday, 20 Dec 2017 06:45am EST 

Dec 20 (Reuters) - Loxo Oncology Inc ::LOXO ONCOLOGY INITIATES ROLLING SUBMISSION OF NEW DRUG APPLICATION TO U.S. FOOD AND DRUG ADMINISTRATION FOR LAROTRECTINIB FOR THE TREATMENT OF TRK FUSION CANCERS.LOXO ONCOLOGY INC - COMPANY EXPECTS TO COMPLETE NDA SUBMISSION IN EARLY 2018.  Full Article

Loxo Oncology Announces Updated Larotrectinib Pediatric Clinical Trial Data Demonstrating Continued Durability Of Response In TRK Fusion Cancers
Monday, 4 Dec 2017 06:45am EST 

Dec 4 (Reuters) - Loxo Oncology Inc ::LOXO ONCOLOGY ANNOUNCES UPDATED LAROTRECTINIB PEDIATRIC CLINICAL TRIAL DATA DEMONSTRATING CONTINUED DURABILITY OF RESPONSE IN TRK FUSION CANCERS.LOXO ONCOLOGY INC - LAROTRECTINIB DEMONSTRATES CENTRAL NERVOUS SYSTEM ACTIVITY WITH FIRST-EVER TRK FUSION GLIOBLASTOMA RESPONSE WITH A TRK INHIBITOR.  Full Article

Bayer may terminate Loxo agreement if Larotrectinib is unapproved
Tuesday, 14 Nov 2017 07:58am EST 

Nov 14 (Reuters) - Loxo Oncology :Agreement with Bayer includes standstill provision preventing Bayer from acquiring 5 percent or more of co's voting securities​.Loxo says Bayer may terminate agreement if co gets CRL from U.S. Food and Drug agency with respect to Larotrectinib - SEC filing​.Bayer may terminate agreement if co does not get marketing approval for Larotrectinib by December 31, 2018​.  Full Article

German stocks - Factors to watch on Nov. 27

BERLIN, Nov 27 The following are some of the factors that may move German stocks on Tuesday: