A very nice article on EXEL from SA: Exelixis (NASDAQ:EXEL) is a company focused on developing small molecule therapies for cancer. Three medicines developed at Exelixis have been met with regulatory approval, including cabozantinib and cobimetinib. Its lead product, Cabometyx (cabozantinib), was approved by the FDA in April 2016 for advanced renal cell carcinoma and resulted in $62 million in 1Q 2017 sales. The drug has about 20% market share of the second line treatment and 35% of the third line.
EXEL has also obtained FDA approval in 2012 for another cabozantinib drug, Cometriq, for treating medullary thyroid carcinoma, resulting in $6.5 million in 1Q 2017 sales, after topping $40 million in 2016. Its third product, Cotellic, won FDA approval for advanced melanoma in 2015 in combination with Roche's (OTCQX:RHHBY) Zelboraf. EXEL posted earnings of $0.05 1Q 2017, has paid down some debt, and earned the prestigious title, "profitable." The company stock has erupted four-fold over the past year, making analysts wonder if it's too late to buy into EXEL.
Label expansion studies for cabozantinib into non-small lung, breast, and endometrial cancers are underway in an impressive eleven mid-stage clinical trial line-up. EXEL stands to gain significant market expansion after having submitted an sNDA for Cabometyx in first line advanced kidney cancer based on Phase 2 results, which would bring the potential annual sales of its big three (Cabometyx, Cometriq, and Cotellic) to approximately $1.5 billion mark for its cabozantinib franchise.
i think most people in this board are still with hope and confidence. i'd like to share a story. i've seen early this year NVIDIA (check its chart if you are not familiar with semiconductor industry) experiences quite similar patterns like EXEL. NVDA price increased ~4X in 2016, but until Q1 of 2017, the price staggered back n forth even dropped after a strong earning report. it was clearly non sense in terms of their stock price vs the bright future/earnings/products of the company. Until the recent earning report in May, though nothing too impressive, price has soared ~40% and stays there for several days already. EXEL may be different and may experience potential manipulations. But why manipulate on a company with bright future?
BIG MONEY IS ACCUMULATED BIG TIME. Something is up. Probably last chance ever to buy here...
Sorry to say but all I see is a big manipulation by big boys to position themselves for a buyout. I wonder if potential suitors and collude with banks or other funds to accumulate shares or short shares and other manipulation to lower the stock price and get a kick-back when offer is made and accepted. I just wonder. I believe they do it under the table and without detection, but you can probably pay them off with next share offering etc. WS is so rigged and its clear...
If this is the reward for beating the earnings estimate (down 30%) I wonder what the pos would be if they had missed the lofty ws expectations?? What a scam. No news from Exelixis and this pps manipulation is very suspicious. Something big is about to happen. I can guarantee that the short ratio has increased the last 2 weeks.
What is this buyout that everybody is talking about? There are not even rumors of buyout, much less any talks.
What are the chances the PPS will be over $50 by the end of the year?
Is +4.19% PM the real deal or 1 share?
Sorry guys - I am out. Sucked it up and took the loss.
Love the company, don't like the trade. The 50 SMA turned over since I entered and not interested in holding over the long weekend.
There must be something brewing for them to take it down from $24.85 to $19.5 in three weeks. Lets see if we get some news before ASCO related to trial update or new partnership/buyout.
8K out Exelixis Files 8K - Changes Exec Mgmt >EXEL
4:28 pm ET May 25, 2017 (Dow Jones) Print Exelixis Inc. (EXEL) filed a Form 8K - Changes in Company Executive Management - with the U.S Securities and Exchange Commission on May 24, 2017.
On May 24, 2017, at the 2017 Annual Meeting of Stockholders (the "Annual Meeting") of Exelixis, Inc. ("Exelixis"), Exelixis' stockholders approved the Exelixis, Inc. 2017 Equity Incentive Plan (the "2017 Plan"). The 2017 Plan was previously approved, subject to stockholder approval, by Exelixis' Board of Directors on February 23, 2017, and amended by the Compensation Committee on March 22, 2017. The 2017 Plan became effective immediately upon stockholder approval at the Annual Meeting.
The terms of the 2017 Plan provide for the grant of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, other stock awards, and performance awards that may be settled in cash, stock, or other property. The 2017 Plan is the successor to the Exelixis, Inc. 2014 Equity Incentive Plan (the "2014 Plan") and no further awards may be granted under the 2014 Plan. Subject to adjustment for certain changes in Exelixis' capitalization, the aggregate number of shares of Exelixis' common stock that may be issued under the 2017 Plan will not exceed the sum of (1) 24,000,000 shares, (2) 453,064 shares, which is the number of unallocated shares remaining available for grant under the 2014 Plan as of May 24, 2017, and (3) shares subject to outstanding stock awards granted under the 2014 Plan, the Exelixis, Inc. 2016 Inducement Award Plan, the Exelixis, Inc. 2000 Equity Incentive Plan, the Exelixis, Inc. 2000 Non-Employee Directors' Stock Option Plan or the Exelixis, Inc. 2011 Equity Incentive Plan (together, the "Prior Plans") that, from and after May 24, 2017 (i) expire or terminate for any reason prior to exercise or settlement, (ii) are forfeited, cancelled or otherwise returned to Exelixis because of the failure to meet a contingency or condition required for the vesting of such shares, or (iii) other than with respect to outstanding stock options and stock appreciation rights granted under the Prior Plans with respect to which the exercise or strike price is at least 100% of the fair market value of the underlying common stock on the date of grant are reacquired or withheld (or not issued) by Exelixis to satisfy a tax withholding obligation in connection with a stock award.
The number of shares of Exelixis' common stock available for issuance under the 2017 Plan will be reduced by (i) one share for each share of common stock issued pursuant to a stock option or stock appreciation right with an exercise or strike price of at least 100% of the fair market value of the underlying common stock on the date of grant, and (ii) 1.5 shares for each share of common stock issued pursuant to a full value award (i.e., any stock award that is not a stock option or stock appreciation right with an exercise or strike price of at least 100% of the fair market value of the underlying common stock on the date of grant).
A more complete summary of the terms of the 2017 Plan is set forth in Exelixis' definitive proxy statement for the Annual Meeting filed with the Securities and Exchange Commission on April 13, 2017 (the "Proxy Statement"). That summary and the foregoing description are qualified in their entirety by reference to the text of the 2017 Plan, which is filed as Exhibit 10.1 hereto and incorporated herein by reference.
Public companies must file a Form 8-K, or current report, with the SEC generally within four days of any event that could materially affect a company's financial position or the value of its shares.
(END) Dow Jones Newswires
May 25, 2017 16:28 ET (20:28 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
Asco is the event that puts focus on oncology stocks, it tends to float all boats. What we need to remember is the submission cut off date for Abstracts was back on Feb 2, most data in the presentation was more than six months ago. What we want to see is updates that excite, last years proclamation that " Exel set the Gold Standard in RCC" was one such benefit of the conference to Exel.
•04:52 am (EXEL, URBN, CHS +2) Watch These 5 Huge Put Purchases In Wednesday Trade I don't know much about option trading. Can someone explain how do PUT and CALL options may affect to the stock price value?
ASCO to watch List JUNE 4 Abstract 4562 A phase I study of cabozantinib plus nivolumab (CaboNivo) and cabonivo plus ipilimumab (CaboNivoIpi) in patients (pts) with refractory metastatic (m) urothelial carcinoma (UC) and other genitourinary (GU) tumors. Poster Board: #240 Andrea B. Apolo, M.D. - First Author Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health
Pretty solid volume. Reassuring
Social, are we still looking at Cabo ph 3 interim results for HCC by end of June? I ask because BMY just got priority reviews for Opdivo for HCC in Previously Treated HCC.... Thx, U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb's Application for Opdivo (nivolumab) in Previously Treated Hepatocellular Carcinoma
11:15 am ET May 24, 2017 (BusinessWire) Print Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma (HCC) after prior sorafenib therapy. The FDA granted the application priority review and previously granted Opdivo orphan-drug designation for the treatment of HCC. The FDA action date is September 24, 2017.
"We believe the FDA acceptance of our application for Opdivo with priority review status is an important recognition of the significant unmet need for patients with HCC, which is often diagnosed in the advanced stage when treatment options are limited," said Ian M. Waxman, M.D., development lead, Gastrointestinal Cancers, Bristol-Myers Squibb. "We are committed to exploring new treatment options for these patients and look forward to working with the FDA to potentially extend the use of Opdivo as a treatment option in this setting."
The submission was based on data from the Phase 1/2 CheckMate -040 study investigating Opdivo in advanced HCC patients with and without hepatitis B virus or hepatitis C virus infections. Data from this study were recently published in The Lancet and will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2017 during a poster discussion session on June 3, 2017 from 4:45-6:00 PM CDT in Hall D2.
About Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the most common type of liver cancer and the second most frequent cause of cancer death worldwide. More than 700,000 people around the world, including about 40,000 people in the United States, are diagnosed with HCC each year. The majority of these cases are caused by hepatitis B virus (HBV) or hepatitis C virus (HCV) infections, making HBV/HCV the most common risk factors for liver cancer.
HCC is often diagnosed in the advanced stage where treatment options are limited and outcomes are poor, with one-year survival rates in the advanced setting of approximately 44%. For patients who are intolerant to or who have progressed during sorafenib therapy, median survival remains less than 11 months with currently available treatment options.
Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research
At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines for hard-to-treat cancers that could potentially improve outcomes for these patients.
We are leading the scientific understanding of I-O through our extensive portfolio of investigational compounds and approved agents. Our differentiated clinical development program is studying broad patient populations across more than 35 types of cancers with 14 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs position us to advance I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O/radiation therapies across multiple tumors and potentially deliver the next wave of therapies with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how patients' individual tumor biology can be used as a guide for treatment decisions throughout their journey.
We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body's own immune system to help restore anti-tumor immune response. By harnessing the body's own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo's leading global development program is based on Bristol-Myers Squibb's scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union and Japan. In October 2015, the company's Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.
Very little volume today, at least the selling has abated.
Just a crazy observation from an old trader - if last week's whippy action continues, I consider it an extremely bullish signal. Just watch it bounce from the 19's.
Hello hello ! So, we just made some lunch money for the rest of the week. How are you feeling ? all those who cried on this board last Monday and were willing to sell. Shame on those who sold. You boys will never learn.