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Loxo Oncology Inc (LOXO.OQ)

LOXO.OQ on NASDAQ Stock Exchange Global Market

77.40USD
20 Nov 2017
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Latest Key Developments (Source: Significant Developments)

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

Loxo Oncology announces positive results from independent review committee assessment of larotrectinib dataset
Wednesday, 18 Oct 2017 06:00am EDT 

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 posts Q3 loss per share $1.14
Tuesday, 8 Aug 2017 06:45am EDT 

Aug 8 (Reuters) - Loxo Oncology Inc :Loxo Oncology announces second quarter 2017 financial results.Loxo Oncology Inc qtrly loss per share $1.14.Q2 earnings per share view $-0.98 -- Thomson Reuters I/B/E/S.  Full Article

Loxo Oncology acquires BTK inhibitor program
Monday, 31 Jul 2017 06:45am EDT 

July 31 (Reuters) - Loxo Oncology Inc :Loxo Oncology announces acquisition of highly selective, reversible BTK inhibitor program.Loxo Oncology Inc - ‍entered into a definitive agreement to purchase Bruton's Tyrosine Kinase inhibitor program from RedX Pharma PLC​.Loxo Oncology Inc - ‍under terms of agreement, Loxo Oncology has made a $40 million payment to RedX Pharma PLC for full acquisition of BTK discovery program​.Loxo Oncology Inc - ‍lead candidate from this program is expected to enter clinical development in 2018​.Loxo Oncology Inc - Loxo Oncology is not subject to milestone or royalty obligations.  Full Article

Redx Pharma says disposal of BTK inhibitor drug development program
Monday, 31 Jul 2017 02:00am EDT 

July 31 (Reuters) - Redx Pharma Plc ::DISPOSAL OF BTK INHIBITOR DRUG DEVELOPMENT PROGRAM.SAYS ‍JOINT ADMINISTRATORS OF CO, UNIT ENTERED INTO AN UNCONDITIONAL AGREEMENT FOR DISPOSAL TO LOXO ONCOLOGY INC.​.SAYS DISPOSAL ‍FOR SUM OF US$40 MILLION​.  Full Article

Loxo Oncology prices follow-on offering of common stock
Wednesday, 14 Jun 2017 09:20pm EDT 

June 14 (Reuters) - Loxo Oncology Inc ::Loxo Oncology prices follow-on offering of common stock.Says public offering of 3.15 million common shares priced at $72.00per share.  Full Article

Loxo Oncology announces proposed public offering of common stock
Tuesday, 13 Jun 2017 04:02pm EDT 

June 13 (Reuters) - Loxo Oncology Inc : :Loxo Oncology announces proposed public offering of common stock.Loxo Oncology- to use proceeds for early commercialization activities for larotrectinib, research and development activities, including those related to Loxo-195, Loxo-292.  Full Article

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Loxo signs lucrative cancer drug deal with Bayer, but shares fall

Loxo Oncology on Tuesday signed a collaboration agreement for its promising cancer drugs with Germany's Bayer AG that could be worth up to $1.55 billion to the tiny U.S. company, but its shares fell 11 percent as the deal appeared to end near-term likelihood of a takeover.