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Exelixis Inc (EXEL.O)

EXEL.O on Nasdaq

9.18USD
29 Jul 2016
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Latest Key Developments (Source: Significant Developments)

EU Medicines Agency recommends approval of two new cancer drugs
Friday, 22 Jul 2016 07:21am EDT 

EU Medicines Agency : EU medicines agency recommendations for july 2016 . Recommends approval of Exelixis Inc’S cabozantinib to treat advanced renal cell carcinoma .Recommends Approval Of Baxter International Inc’S Irinotecan to treat pancreatic cancer.  Full Article

Exelixis, Ipsen post results from advanced renal cell carcinoma study
Monday, 6 Jun 2016 07:30am EDT 

Exelixis Inc : Exelixis and its partner Ipsen announce positive overall survival results from subgroup analyses of phase 3 trial of CABOMETYX(tm) (cabozantinib) tablets in advanced renal cell carcinoma at 2016 ASCO annual meeting .Additional data from pivotal meteor trial underscore clinically meaningful benefit of CABOMETYX across subgroups of patients.  Full Article

Exelixis and Ipsen announce Phase 3 trial results of CABOMETYX
Monday, 6 Jun 2016 02:31am EDT 

Exelixis Inc and Ipsen :Announced on Sunday Phase 3 trial results of CABOMETYX (cabozantinib) tablets demonstrating significant overall survival benefit for previously treated patients with advanced renal cell carcinoma presented at ASCO.  Full Article

Exelixis and Ipsen announce Phase 3 trial results of CABOMETYX
Sunday, 5 Jun 2016 07:36am EDT 

Exelixis Inc and Ipsen :Announced on Sunday Phase 3 trial results of CABOMETYX (cabozantinib) tablets demonstrating significant overall survival benefit for previously treated patients with advanced renal cell carcinoma presented at ASCO.  Full Article

Ipsen SA says Exelixis Inc reported positive top-line results from Cabosun phase 2 trial of Cabozantinib
Monday, 23 May 2016 02:31pm EDT 

Ipsen Sa says Exelixis Inc: reported positive top line results from Cabosun phase 2 trial of Cabozantinib in patients with untreated advanced renal cell carcinoma . Trial met its primary endpoint, statistically significant improvement in progression-free survival for Cabozantinib compared with Sunitinib .Safety data in Cabozantinib-treated arm of study were consistent with those observed in previous studies in patients with advanced rcc.  Full Article

Exelixis says phase 2 trial met primary endpoint for advanced renal cell carcinoma
Monday, 23 May 2016 09:02am EDT 

Exelixis : Trial met its primary endpoint .Announces results from randomized phase 2 trial cabosun demonstrate cabozantinib significantly improved progression free survival versus sunitinib in previously untreated advanced renal cell carcinoma.  Full Article

Exelixis and Ipsen enter into exclusive licensing agreement
Tuesday, 1 Mar 2016 01:00am EST 

Ipsen SA:Exelixis and Ipsen enter into exclusive licensing agreement to commercialize and develop novel cancer therapy cabozantinib in regions outside the United States, Canada and Japan.Ipsen will have exclusive commercialization rights for current and potential future cabozantinib indications outside the United States, Canada and Japan.Exelixis will receive $200 million upfront payment and subsequent regulatory and commercial milestones ‍​.The agreement also includes up to $545 million of potential commercial milestones and provides for Exelixis to receive tiered royalties up to 26 pct on Ipsen`s net sales of cabozantinib in its territories.  Full Article

FDA approves Exelixis Inc's Cotellic (Cobimetinib) for use in Combination with Vemurafenib to Treat Advanced Melanoma
Tuesday, 10 Nov 2015 01:37pm EST 

Exelixis Inc:Announced that the U.S. Food and Drug Administration (FDA) has approved COTELLIC (cobimetinib) as a treatment for patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with vemurafenib.Says Cotellic is expected to be available in the U.S. within two weeks.Says Exelixis and Genentech to co-promote cotellic in the United States.Roche anticipates a decision from the European Commission by year-end.  Full Article

Exelixis Inc Announces Positive Overall Survival Results from Phase 3 Pivotal Trial
Tuesday, 6 Oct 2015 01:00am EDT 

Exelixis Inc:Says a positive overall survival (OS) results from coBRIM, the phase 3 pivotal trial evaluating cobimetinib, in combination with vemurafenib in previously untreated patients with unresectable locally advanced or metastatic melanoma carrying a BRAF V600 mutation.Exelixis' collaborator Genentech, informed the co that coBRIM met its secondary endpoint of demonstrating a statistically significant and clinically meaningful increase in overall survival for patients receiving the combination of cobimetinib and vemurafenib, as compared to vemurafenib monotherapy.Ongoing study monitoring did not identify any new safety signals.Long-term safety data are expected later this year.  Full Article

Exelixis Inc announces positive results from METEOR Phase 3 pivotal trial of cabozantinib
Friday, 25 Sep 2015 06:09pm EDT 

Exelixis Inc:Says Cabozantinib showed a strong trend towards improving overall survival as compared to everolimus at an interim analysis.Says Cabozantinib met the primary endpoint of improving progression-free survival as compared to everolimus.U.S. and EU regulatory filings anticipated by end of 2015 and early 2016, respectively.  Full Article

BRIEF-Ipsen and Exelixis receive positive CHMP opinion for Cabometyx

* Ipsen and its partner Exelixis receive positive CHMP opinion for Cabometyx (cabozantinib) for treatment of advanced renal cell carcinoma in adults