Edition:
United Kingdom

Loxo Oncology Inc (LOXO.OQ)

LOXO.OQ on NASDAQ Stock Exchange Global Market

78.97USD
15 Dec 2017
Change (% chg)

$-3.98 (-4.80%)
Prev Close
$82.95
Open
$83.12
Day's High
$83.12
Day's Low
$75.87
Volume
661,312
Avg. Vol
160,572
52-wk High
$95.78
52-wk Low
$26.36

Latest Key Developments (Source: Significant Developments)

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

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 

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 

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 

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 

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

Loxo Oncology announces positive results from independent review committee assessment of larotrectinib dataset
Wednesday, 18 Oct 2017 

Oct 18 (Reuters) - Loxo Oncology Inc :Loxo Oncology announces positive top-line results from independent review committee assessment of larotrectinib dataset.Loxo Oncology Inc - ‍75% overall response rate by independent review; 80% overall response rate by investigator assessment​.Loxo Oncology Inc - ‍larotrectinib adverse event profile is consistent with data previously presented publicly.Loxo Oncology - ‍consistent with prior guidance, co expects to submit NDA for evaluation by U.S. FDA in late 2017 or early 2018​.Loxo Oncology - expects to submit marketing authorisation application for evaluation of larotrectinib dataset​ by EMA in 2018.  Full Article

Loxo Oncology Q2 net loss per share $0.77
Wednesday, 3 Aug 2016 

Loxo Oncology Inc : Loxo oncology announces second quarter 2016 financial results . Qtrly net loss per share $0.77 . Q2 earnings per share view $-0.63 -- Thomson Reuters I/B/E/S .Continues to expect cash burn of $48 to $52 million in 2016.  Full Article

Loxo Oncology's LOXO-101 wins FDA's breakthrough therapy status
Wednesday, 13 Jul 2016 

Loxo Oncology Inc : Loxo Oncology Receives Breakthrough Therapy Designation From U.S. Food And Drug Administration For LOXO 101 .Remain on track to provide an enrollment update regarding loxo-101 phase 2 trial in second half of 2016.  Full Article

Aisling Capital III reports 18.6 pct stake in Loxo Oncology
Friday, 27 May 2016 

Loxo Oncology Inc :Aisling Capital III, LP reports a stake of 18.6% in Loxo Oncology Inc as of May 17, 2016 - SEC filing.  Full Article

Loxo Oncology prices follow-on offering of common stock
Thursday, 12 May 2016 

Loxo Oncology Inc :Prices follow-on offering of common stock.  Full Article

BRIEF-Loxo Oncology Announces Updated Larotrectinib Pediatric Clinical Trial Data Demonstrating Continued Durability Of Response In TRK Fusion Cancers

* LOXO ONCOLOGY ANNOUNCES UPDATED LAROTRECTINIB PEDIATRIC CLINICAL TRIAL DATA DEMONSTRATING CONTINUED DURABILITY OF RESPONSE IN TRK FUSION CANCERS