Stock Monitor: Eyenovia Post Earnings Reporting
LONDON, UK / ACCESSWIRE / May 21, 2018 / If you want access to our free research report on Exelixis, Inc. (NASDAQ: EXEL), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=EXEL as the Company's latest news hit the wire. On May 17, 2018, the Company announced that the European Commission (EC) has approved the Company's partner Ipsen for CABOMETYX® (cabozantinib) 20 mg, 40 mg, and 60 mg for the first-line treatment of adults with intermediate- or poor-risk advanced renal cell carcinoma (RCC) in the European Union. Register today and get access to over 1,000 Free Research Reports by joining our site below:
Active-Investors.com is currently working on the research report for Eyenovia, Inc. (EYEN), which also belongs to the Healthcare sector as the Company Exelixis. Do not miss out and become a member today for free to access this upcoming report at:
Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Exelixis most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:
Under the terms of the collaboration with Ipsen, Exelixis will receive a milestone payment of $50 million for the EC approval, of which approximately $46 million was recognized as collaboration revenue in Q1 2018. The payment will be made by Ipsen within the next 70 days.
Expanded EC Approval to Include First-Line Treatment is Based on Results of CABOSUN Trial
CABOMETYX was approved in the European Union in September 2016 for the treatment of advanced RCC in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. The expanded EC approval to include first-line treatment is based on results of the CABOSUN trial, which met its primary endpoint of improved progression-free survival (PFS) compared to sunitinib in patients with previously untreated advanced RCC determined to be intermediate-or poor-risk by the International Metastatic RCC Database Consortium criteria.
CABOSUN was a randomized, open-label, active-controlled phase-2 trial conducted in May 2016 that enrolled 157 patients with advanced RCC determined to be intermediate-or poor-risk by the IMDC criteria. Patients were randomized 1:1 to receive cabozantinib (60 mg once daily) or sunitinib (50 mg once daily, 4 weeks on followed by 2 weeks off). The primary endpoint was PFS. Eligible patients were required to have locally advanced or metastatic clear-cell RCC.
FDA and CHMP Approved CABOMETYX® for Previously Untreated Intermediate- or Poor-Risk Advanced RCC
On March 23, 2018, Ipsen received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), for CABOMETYX® 20 mg, 40 mg, and 60 mg for the first-line treatment of adults with intermediate-or poor-risk advanced RCC. On December 19, 2017, the US Food and Drug Administration (FDA) approved CABOMETYX® for the expanded indication of patients with advanced RCC based on the results from the CABOSUN trial.
Post announcement of the news, shares of Exelixis surged in pre-market trade.
About Renal Cell Carcinoma
RCC is a kidney cancer that originates in the lining of the proximal convoluted tubule, a part of the very small tubes in the kidney that transport primary urine. RCC is the most common type of kidney cancer in adults. Initial treatment is most commonly either partial or complete removal of the affected kidney(s). Where the cancer has not metastasized or burrowed deeper into the tissues of the kidney, the five-year survival rate is 65%–90%, but this is lowered considerably when the cancer has spread. The body is remarkably good at hiding the symptoms and as a result people with RCC often have advanced disease by the time it is discovered.
About CABOMETYX® (cabozantinib)
Cabometyx® is an oral small molecule inhibitor of receptors, including VEGFR, MET, AXL, and RET. In preclinical models, cabozantinib has been shown to inhibit the activity of these receptors, which are involved in normal cellular function and pathologic processes such as tumor angiogenesis, invasiveness, metastasis and drug resistance. Cabometyx® is available in 20 mg, 40 mg, or 60 mg doses. The recommended dose is 60 mg orally, once daily
Exelixis and Ipsen Collaboration
In February 2016, Exelixis and Ipsen jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications outside of the United States, Canada, and Japan. This agreement was amended in December 2016 to include commercialization rights for Ipsen in Canada. On April 25, 2016, the FDA approved Cabometyx® tablets for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy and on September 09, 2016, EC approved Cabometyx® tablets for the treatment of advanced RCC in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy in the European Union, Norway, and Iceland.
Stock Performance Snapshot
May 18, 2018 - At Friday's closing bell, Exelixis' stock was slightly up 0.09%, ending the trading session at $21.58.
Volume traded for the day: 3.59 million shares.
Stock performance in the last month – up 2.32%; and past twelve-month period – up 2.62%
After last Friday's close, Exelixis' market cap was at $6.40 billion.
Price to Earnings (P/E) ratio was at 26.67.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.2% at the end of the session.
Active-Investors (A-I) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and Canadian stocks. A-I has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below.
A-I has not been compensated; directly or indirectly; for producing or publishing this document.
PRESS RELEASE PROCEDURES:
The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third-party research service company (the "Reviewer") represented by a credentialed financial analyst [for further information on analyst credentials, please email email@example.com. Rohit Tuli, a CFA® charterholder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by A-I. A-I is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way.
A-I, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. A-I, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, A-I, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice.
NOT AN OFFERING
This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither A-I nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://active-investors.com/legal-disclaimer/.
For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at:
Phone number: 73 29 92 6381
Office Address: 6, Jalan Kia Peng, Kuala Lumpur, 50450 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.