Key Developments: Exelixis Inc (EXEL.O)

EXEL.O on Nasdaq

3.15USD
22 May 2015
Change (% chg)

$0.01 (+0.32%)
Prev Close
$3.14
Open
$3.14
Day's High
$3.16
Day's Low
$3.04
Volume
2,160,356
Avg. Vol
3,610,556
52-wk High
$4.55
52-wk Low
$1.26

Search Stocks

Latest Key Developments (Source: Significant Developments)

Exelixis Inc's cabozantinib grants Fast Track designation by FDA for advanced renal cell carcinoma
Thursday, 9 Apr 2015 08:30am EDT 

Exelixis Inc:Says U.S. Food & Drug Administration (FDA) grants Fast Track designation to cabozantinib for treatment of patients with advanced renal cell carcinoma (RCC) who have received one prior therapy.Says Cabozantinib is it's lead compound and inhibits activity of multiple tyrosine kinases including MET, VEGFRs and RET.Cabozantinib is subject of METEOR, an ongoing phase 3 pivotal trial in patients with metastatic RCC who have experienced disease progression following treatment with at least one VEGFR tyrosine kinase inhibitor.Exelixis expects to release top-line results from trial in Q2 of 2015.In addition to metastatic RCC development program, Exelixis is also evaluating cabozantinib in CELESTIAL, a phase 3 pivotal trial in second-line hepatocellular carcinoma (HCC).  Full Article

Exelixis Inc issues earnings guidance for FY 2015
Thursday, 26 Feb 2015 10:13am EST 

Exelixis Inc:Announces that results for FY 2015 are expected to be in the same levels with the results of previous year.  Full Article

Exelixis Inc announces acceptance of new drug application for cobimetinib in combination with Vemurafenib for treatment of patients with BRAF V600 mutation-positive advanced Melanoma
Thursday, 19 Feb 2015 01:00am EST 

Exelixis Inc:Says that the U.S. Food and Drug Administration has accepted for review Genentech's New Drug Application for cobimetinib in combination with vemurafenib for patients with unresectable or metastatic melanoma harboring a BRAF V600 mutation.Cobimetinib is a specific MEK inhibitor that was discovered by Exelixis and is now the subject of a worldwide co-development agreement between Exelixis and Genentech, a member of the Roche Group.FDA has granted Priority Review to the NDA and assigned a Prescription Drug User Fee Act (PDUFA) action date of Aug. 11, 2015.  Full Article

Exelixis Inc and Swedish Orphan Biovitrum AB (Sobi) extend and restructure distribution agreement for COMETRIQ
Wednesday, 7 Jan 2015 08:30am EST 

Exelixis Inc:Has extended and restructured its agreement with Swedish Orphan Biovitrum AB (Sobi).To support distribution and commercialization of COMETRIQ (cabozantinib) for progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC) in the European Union (EU), Switzerland, Norway, Russia, and Turkey.Says agreement, which was established in Feb. 2013 and due to expire on Dec.31 will extend to Dec. 31, 2019.Moreover, payment structure of partnership will transition from fixed fees paid by Exelixis to Sobi to support initial build out of COMETRIQ European commercial infrastructure to a sales margin-based approach.Exelixis continues to maintain commercial rights for all other potential cabozantinib oncology indications on global basis.  Full Article

Exelixis Inc. files new drug application
Monday, 15 Dec 2014 01:00am EST 

Exelixis Inc:Says that it has completed the filing of its New Drug Application with FDA for cobimetinib, a specific MEK inhibitor discovered by Exelixis.Says it is in combination with vemurafenib for previously untreated patients with unresectable locally advanced or metastatic melanoma harboring a BRAF V600 mSays Cobimetinib has received Fast Track designation by the FDA.Roche submitted a Marketing Authorization Application for the combination to the European Medicines Agency in Sept. of this yearutation.  Full Article

Exelixis announces results from COMET-2 Pivotal Phase 3 Trial
Monday, 1 Dec 2014 08:00am EST 

Exelixis Inc:Says top-line results from the final analysis of COMET-2 a randomized, double-blind, controlled trial of cabozantinib in men with metastatic castration-resistant prostate cancer.Trial did not meet its primary endpoint of alleviation of bone pain, as determined by comparing the percentage of patients in the two treatment arms who achieved a pain response at Week 6 that was confirmed at Week 12 without increase in narcotic medication.To submit the results from the COMET program for potential presentation at a future medical meeting.  Full Article

Exelixis, Inc announces positive preliminary data from an investigator-sponsored Phase 1 trial of XL888 and vemurafenib
Saturday, 15 Nov 2014 10:00pm EST 

Exelixis, Inc:Announces preliminary results from a phase 1 investigator-sponsored trial (IST) evaluating the safety and activity of XL888.Says that it discovered small molecule oral inhibitor of Heat Shock Protein 90 (HSP90), in combination with vemurafenib in patients with unresectable stage III/IV BRAF V600 mutation-positive melanoma.Says safety and efficacy results support the further investigation of 90 mg of XL888 twice weekly (BIW) and vemurafenib 960 mg twice daily (BID) in additional studies that would include a third agent.Says that based on these results, as well as findings from coBRIM, the phase 3 pivotal trial of cobimetinib, an Exelixis-discovered MEK inhibitor, and vemurafenib in previously untreated metastatic melanoma patients with a BRAF V600 mutation.Says the Moffitt Center plans to initiate a phase 1b IST of the triple combination of vemurafenib, cobimetinib, and XL888 in a similar patient population.  Full Article

Exelixis Inc announces positive top-line results from a phase 2 trial of Cabozantinib and Erlotinib in patients with EGFR Wild-Type Non-Small Cell Lung Cancer
Tuesday, 4 Nov 2014 04:14pm EST 

Exelixis Inc:Says positive top-line results from a randomized phase 2 trial of cabozantinib and erlotinib alone or in combination as second- or third-line therapy in patients with stage IV EGFR wild-type non-small cell lung cancer (NSCLC).This trial (Study E1512) is sponsored by the U.S. National Cancer Institute (NCI) through a Cooperative Research and Development Agreement between the Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis, NCI and Exelixis.Study E1512 was designed and is being conducted by the ECOG-ACRIN Cancer Research Group as part of Exelixis' collaboration with the NCI.  Full Article

Exelixis Inc announces positive results from phase 3 pivotal trial of cobimetinib in combination with vemurafenib in patients with BRAF V600 Mutation-Positive Advanced Melanoma
Monday, 29 Sep 2014 03:00am EDT 

Exelixis Inc:Says positive results from coBRIM, the phase 3 pivotal trial conducted by Exelixis' collaborator Genentech, a member of the Roche Group, evaluating cobimetinib.A specific MEK inhibitor discovered by Exelixis, in combination with vemurafenib in previously untreated patients with unresectable locally advanced or metastatic melanoma harboring a BRAF V600 mutation.Trial met its primary endpoint of demonstrating a statistically increase in investigator-determined progression-free survival (PFS).The median PFS was 9.9 months for the combination of cobimetinib and vemurafenib versus 6.2 months for vemurafenib alone (hazard ratio [HR]=0.51, 95 percent CI 0.39-0.68; p<0.0001), demonstrating the combination reduced the risk of the disease worsening by half (49 percent).The median PFS by independent review committee (IRC), a secondary endpoint, was 11.3 months for the combination arm compared to 6.0 months for the control arm (HR=0.60, 95 percent CI 0.45-0.79; p=0.0003).Objective response rate (ORR), another secondary endpoint, was 68% for the combination versus 45% for vemurafenib alone (p<0.0001).Overall survival data are not yet mature (HR=0.65, 95 percent CI 0.42-1.00; p=0.046), and at the interim analysis the p-value did not cross the prespecified boundary for significance.Safety profile of the combination was consistent with that observed in a previous study.  Full Article

Exelixis Inc announces results from COMET-1 Phase 3 pivotal trial of cabozantinib in men with metastatic castration-resistant prostate cancer
Monday, 1 Sep 2014 06:00pm EDT 

Exelixis Inc:Says phase 3 pivotal trial of cabozantinib in men with metastatic castration-resistant prostate cancer (mCRPC) whose disease progressed after treatment with docetaxel as well as abiraterone and/or enzalutamide.Trial did not meet its primary endpoint of demonstrating a statistically significant increase in overall survival (OS) for patients treated with cabozantinib as compared to prednisone.  Full Article

Search Stocks