Key Developments: Exelixis Inc (EXEL.O)

EXEL.O on Nasdaq

3.33USD
2:29pm EDT
Price Change (% chg)

$0.01 (+0.30%)
Prev Close
$3.32
Open
$3.28
Day's High
$3.44
Day's Low
$3.26
Volume
1,977,402
Avg. Vol
5,495,136
52-wk High
$8.41
52-wk Low
$3.02

Search Stocks

Latest Key Developments (Source: Significant Developments)

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

Exelixis Inc announces pricing of overnight offering of 10,000,000 shares of common stock
Thursday, 23 Jan 2014 08:33am EST 

Exelixis Inc:Says pricing of its overnight underwritten public offering of 10,000,000 shares of newly issued common stock at a price to the public of $8.00 per share.Says it also granted the underwriter a 30-day option to purchase up to an additional 1,500,000 shares of common stock in connection with the offering.Says all of the shares of common stock in the offering are being sold by company.Says net proceeds from the offering will be $75.6 mln after deducting the underwriting discount and estimated offering expenses payable by company.Says offering is expects to close the offering on or about Jan. 28, subject to customary closing conditions.  Full Article

Exelixis Inc launches proposed overnight public offering of common stock
Wednesday, 22 Jan 2014 04:00pm EST 

Exelixis Inc:Says it plans to offer 10,000,000 shares of its common stock in an overnight underwritten public offering.Says the company expects to grant the underwriter a 30-day option to purchase up to an additional 1,500,000 shares of common stock in connection with the offering.Says all of the shares of common stock in the offering will be sold by Exelixis.Says Cowen and Company is acting as underwriter for the offering.  Full Article

Exelixis Inc initiates phase 2 clinical trial of Cabozantinib Plus Abiraterone
Monday, 2 Dec 2013 06:00am EST 

Exelixis Inc:Says it initiates a phase 2 clinical trial.Says it compares cabozantinib plus abiraterone and prednisone (abiraterone/prednisone) versus abiraterone/prednisone in patients.  Full Article

Exelixis Inc Announces COMETRIQ (cabozantinib) Clinical Trial Data in Patients with Progressive, Metastatic Medullary Thyroid Cancer
Sunday, 2 Jun 2013 09:00am EDT 

Exelixis Inc announced the presentation of additional data from clinical trials of COMETRIQ (cabozantinib) in patients with progressive, metastatic medullary thyroid cancer (MTC). Long-term follow-up of a phase 1 trial (Abstract #6090) shows that 30% of progressive, metastatic MTC patients treated with COMETRIQ experienced disease control (DC) and have remained progression-free for more than two years. A separate presentation (Abstract #6000) reports data from the prospective analysis of RET mutational status and retrospective ad hoc analysis of RAS mutational status of patients in EXAM, Exelixis` phase 3 pivotal trial of COMETRIQ in progressive, metastatic MTC. These data show improvement in progression-free survival (PFS) with COMETRIQ treatment compared to placebo in all genetically defined subgroups, with a greater effect on PFS seen in the RET mutation positive and RET mutation unknown subgroups. The U.S. Food & Drug Administration approved COMETRIQ for the treatment of progressive, metastatic MTC in November 2012. The label allows for use of COMETRIQ in progressive, metastatic MTC without regard to mutation status.  Full Article

Exelixis Inc Announces Presentation of Updated Phase 2 Data for Cabozantinib in Men with Heavily-Pretreated Metastatic Castration-Resistant Prostate Cancer
Saturday, 1 Jun 2013 09:00am EDT 

Exelixis Inc announced updated interim data from 144 docetaxel-pretreated patients with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases treated with cabozantinib in an ongoing non-randomized expansion (NRE) cohort of its phase 2 randomized discontinuation trial. Median overall survival was 10.8 months in a patient population in which 73% of patients had received two or more prior therapies including docetaxel and abiraterone, enzalutamide, and/or cabazitaxel. Furthermore, a retrospective analysis of the interim data shows that early responses in bone scan, circulating tumor cell (CTC) levels, and pain are associated with longer median overall survival (OS) as compared to non-responders. These post hoc findings, particularly the bone scan response results, support the rationale for potential future prospective validation of the association of bone scan response with OS in Exelixis` ongoing phase 3 COMET trials in mCRPC. The interim results presented comprise data from 144 men with mCRPC in the NRE cohort of an ongoing phase 2 randomized discontinuation trial. All patients had disease progression in either bone or soft tissue disease within 6 months of completion of docetaxel treatment, and the protocol differed from typical CRPC studies in that it excluded patients who progressed by PSA criteria alone, who generally have a better overall prognosis. All patients also had bone metastases on bone scan and 31% had measurable soft tissue disease.  Full Article

Swedish Orphan Biovitrum AB Signs Distribution and Commercialization Agreement with Exelixis Inc Regarding COMETRIQ
Friday, 22 Feb 2013 02:30am EST 

Swedish Orphan Biovitrum AB (Sobi) announced that Sobi and Exelixis Inc have entered into a three-year agreement to support the distribution and commercialization of COMETRIQ (cabozantinib) for metastatic medullary thyroid cancer (MTC) in the European Union (EU) and potentially other countries. No other indication is covered by this agreement, and Exelixis maintains full commercial rights for COMETRIQ in MTC outside the covered territory and for all other indications on a global basis. On November 29, 2012, Exelixis announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for COMETRIQ for the proposed indication of treatment of progressive, unresectable, locally advanced, or metastatic MTC. Under the terms of the agreement, Exelixis will continue to be responsible for regulatory approvals in the covered territory. Sobi will serve as the exclusive distributor of COMETRIQ in the covered territory where applicable for NPU requests, and will, if approved by the EMA, promote, market, and sell COMETRIQ for MTC in the covered territory. Exelixis' payments to Sobi include certain pre-determined fixed fees as well as potential performance based milestones related to the commercialization of the product in the covered territory. Exelixis will book revenues based on product sold to Sobi. Exelixis has the ability to terminate the agreement at will at any time upon payment of certain pre-determined fees.  Full Article

Exelixis Inc Reaffirms FY 2012 Revenue Guidance
Wednesday, 7 Nov 2012 04:17pm EST 

Exelixis Inc announced that it continues to expects fiscal 2012 revenues in the range of $40.0 million to $60.0 million. According to I/B/E/S Estimates, analysts on an average are expecting the Company to report revenue of $45.7 million for fiscal 2012.  Full Article

Exelixis Inc Announces Interim Data for Cabozantinib 40 mg Dose Cohort in Metastatic Castration-Resistant Prostate Cancer
Sunday, 30 Sep 2012 05:45am EDT 

Exelixis Inc announced interim data from 51 patients with metastatic castration-resistant prostate cancer (CRPC) and bone metastases receiving a 40 mg daily dose of cabozantinib in an ongoing non-randomized expansion (NRE) cohort of a phase 2 randomized discontinuation trial. The data suggest that the 40 mg daily dose has similar clinical activity to the 100 mg daily dose previously reported from this trial for key parameters, including reduction of metastatic bone and soft tissue disease, and reduction of bone-related pain and narcotic use, with apparent improvement in adverse event rates and tolerability. The interim results reported include data from 51 men enrolled in the 40 mg NRE cohort of an ongoing phase 2 randomized discontinuation trial. All patients had bone metastases on bone scan and 41% had measurable soft tissue disease. All patients had received prior docetaxel, 67% had received prior abiraterone or enzalutamide (MDV3100), and 25% had received prior cabazitaxel. Bone-directed therapies such as zoledronic acid, denosumab, and radionuclides were used in 45%, 41% and 6% of patients, respectively. 71% of patients had received at least 2 prior lines of therapy for CRPC. Clinically significant pain, defined as baseline pain score by Brief Pain Inventory (BPI) ≥4, was present in 53% of patients, with 45% of these patients receiving chronic narcotic administration.  Full Article

Search Stocks