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Loxo Oncology Inc (LOXO.OQ)

LOXO.OQ on NASDAQ Stock Exchange Global Market

179.17USD
18 Jun 2018
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$2.24 (+1.27%)
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Latest Key Developments (Source: Significant Developments)

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

Bayer, Loxo Oncology form partnership to develop, commercialise cancer drugs​
Tuesday, 14 Nov 2017 07:00am EST 

Nov 14 (Reuters) - Bayer Ag :Says it and loxo oncology to develop and commercialize two novel oncology therapies selectively targeting genetic drivers of cancer​.Says alliance to ‍target genetic drivers of cancer larotrectinib (loxo-101) and loxo-195 target tropomyosin receptor kinase (trk) fusion proteins​.Says ‍first filing for larotrectinib is planned in u.s. In late 2017 or early 2018, with eu filing expected in 2018.​.Says ‍loxo oncology will receive an upfront payment of usd 400 million and is eligible for usd 450 million in milestone payments​.Says ‍additional usd 200 million in milestone payments upon loxo-195 regulatory approvals and first commercial sale events in certain major markets.​.Says ‍will share development costs on a 50/50 basis.​.Says ‍bayer will lead ex-u.s. Regulatory activities, and worldwide commercial activities.​.Says ‍in u.s., where bayer and loxo oncology will co-promote products, parties will share commercial costs and profits on a 50/50 basis.​.Says ‍bayer will pay loxo oncology tiered double-digit percentage royalties on future net sales outside of u.s. And u.s. And ex-u.s. Sales milestones totaling usd 500 million.​.  Full Article

Loxo Oncology announces development and commercialization partnership with Bayer for cancer drugs
Tuesday, 14 Nov 2017 07:00am EST 

Nov 14 (Reuters) - Loxo Oncology Inc :Loxo Oncology announces global development and commercialization partnership with Bayer for larotrectinib and LOXO-195.Loxo Oncology Inc - ‍Loxo Oncology and Bayer to co-promote in U.S. with a 50/50 profit share; Bayer to commercialize RoW​.Loxo Oncology Inc - ‍under terms of agreement, Loxo Oncology will receive a $400 million upfront payment​.Loxo Oncology Inc - deal includes ‍up to $1.55 billion in upfront, regulatory, and commercial milestones​.Loxo Oncology - co eligible for $450 million in milestone payments upon larotrectinib approvals, first commercial sale events in some markets​.Loxo Oncology - co also eligible for additional $200 million in payments upon LOXO-195 approvals, first commercial sale events in some markets​.Loxo Oncology - ‍outside of U.S., ​Bayer will pay co royalties on sales, sales milestones totaling $475 million for larotrectinib & LOXO-195.  Full Article

Loxo Oncology reports quarterly loss per share of ‍$2.45
Thursday, 2 Nov 2017 06:45am EDT 

Nov 2 (Reuters) - Loxo Oncology Inc ::Loxo Oncology announces third quarter 2017 financial results.Qtrly non-GAAP loss per share ‍$0.94.‍Larotrectinib New Drug Application (NDA) submission to U.S. FDA on track for year end 2017 / early 2018​.Qtrly GAAP loss per share ‍$2.45​.  Full Article

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Loxo-Bayer cancer drug gets priority review from FDA

Loxo Oncology and Bayer AG said on Tuesday the U.S. Food and Drug Administration granted priority review to their cancer drug and would decide on the marketing application by Nov. 26.