Key Developments: Exelixis Inc (EXEL.O)

EXEL.O on Nasdaq

1.33USD
19 Dec 2014
Price Change (% chg)

$-0.02 (-1.48%)
Prev Close
$1.35
Open
$1.39
Day's High
$1.42
Day's Low
$1.32
Volume
12,186,749
Avg. Vol
2,850,167
52-wk High
$8.41
52-wk Low
$1.28

Search Stocks

Latest Key Developments (Source: Significant Developments)

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

Exelixis, Inc announces positive top line results for phase 3 pivotal trial of cobimetinib in combination with vemurafenib
Monday, 14 Jul 2014 01:00am EDT 

Exelixis, Inc:Announces positive top line results from coBRIM, the phase 3 pivotal trial evaluating cobimetinib, a specific MEK inhibitor discovered by Exelixis.Says it is in combination with vemurafenib in previously untreated patients with unresectable locally advanced or metastatic melanoma harboring the BRAF(V600)mutation.Exelixis' collaborator Genentech, a member of the Roche Group, informed the company that coBRIM met its primary endpoint, delivering a statistically increase in progression-free survival (PFS) for the combination of cobimetinib plus vemurafenib as compared to vemurafenib alone.Adverse events were consistent with those observed in a previous study of the combination.  Full Article

Exelixis, Inc announces CFO change - Form 8-K
Thursday, 8 May 2014 04:30pm EDT 

Exelixis, Inc:Says it and Frank Karbe, the executive vice president and chief financial officer, have entered into a transition and consulting agreement dated May 7 and effective as of May 2 pursuant to which Karbe‚Äôs employment with the company will cease on June 2.Effective on the transition date, Deborah Burke, the vice president, finance and controller, will assume the role of interim chief financial officer until a permanent replacement is named.  Full Article

Exelixis, Inc update on ongoing COMET-1 Phase 3 pivotal trial in men with metastatic castration-resistant prostate cancer
Tuesday, 25 Mar 2014 07:30pm EDT 

Exelixis, Inc:Says that the Independent Data Monitoring Committee (IDMC) notified the company that a planned interim analysis of the COMET-1 phase 3 pivotal trial has been completed.That the IDMC recommended the trial proceed to its final analysis.Exelixis continues to anticipate top-line data from COMET-1 in 2014.  Full Article

Exelixis, Inc receives approval for COMETRIQ in the european union
Tuesday, 25 Mar 2014 06:00am EDT 

Exelixis, Inc:Says European Commission has approved COMETRIQ (cabozantinib) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC).The European Commission granted conditional marketing authorization following a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) issued in Dec. 2013.  Full Article

UPDATE 1-Roche, GSK melanoma pill combinations look similar in showdown

* Shares in Roche's biotech partner Exelixis jump 20 pct (Adds Exelixis share price jump, more on treatment debate)

Search Stocks