20.84 0.00 (0.00%)
After hours: 4:31PM EDT
|Bid||20.58 x 2900|
|Ask||21.00 x 34100|
|Day's Range||20.31 - 20.90|
|52 Week Range||18.03 - 32.50|
|PE Ratio (TTM)||42.27|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||N/A|
In the first quarter, Bristol-Myers Squibb’s (BMY) Opdivo witnessed sales close to $1.5 billion, driven by a robust rise in demand across the approved indications of lung cancer, renal cell carcinoma (or RCC), head and neck cancer, and melanoma. Further, the company is also witnessing robust uptake of Opdivo as adjuvant therapy for melanoma patients. To know more about Opdivo as an adjuvant melanoma therapy, please read Opdivo Could Be Key Revenue Driver for Bristol-Myers Squibb in 2018.
Label expansion of a few prominent drugs along with pipeline updates were the key areas of focus for investors in the biotech space.
Exelixis (EXEL) is focused on the label expansion and life cycle management of the cabozantinib franchise in collaboration with Bristol-Myers Squibb (BMY) and Roche Holdings (RHHBY). The above diagram shows the rationale for studying cabozantinib in combination with immunotherapy in multiple cancer indications. Exelixis is currently evaluating the safety and preliminary activity, in terms of objective response rate and progression-free survival, of a combination of cabozantinib with nivolumab and a combination of cabozantinib with nivolumab and ipilimumab in advanced hepatocellular carcinoma (or HCC) indications in an ongoing Phase 2 trial.
On January 16, Exelixis (EXEL) and Ipsen announced positive results from the CELESTIAL Phase 3 trial highlighting the statistically significant and clinically meaningful improvement in the trial’s primary end point of overall survival due to cabozantinib therapy compared to a placebo in second-line and third-line hepatocellular carcinoma (or HCC) patients.
In the first quarter, Exelixis’s (EXEL) Cabometyx witnessed more than a 20% sequential rise in prescription volume driven by both new patient starts and a robust rise in the total number of patients on the therapy. According to a report, ~295,000 people across the world are diagnosed with kidney cancer every year, while 134,000 kidney cancer patients die every year. According to the American Cancer Society’s Cancer Facts & Figures 2018, the annual incidence of kidney cancer in the United States is ~65,000, while the annual death toll of the disease is 15,000. Another report estimates that almost 70%–75% of renal cell cancer (or RCC) patients suffer from clear cell RCC.
Exelixis (EXEL) aims to position Cabometyx as the preferred tyrosine-kinase inhibitor (or TKI) in the renal cell carcinoma (or RCC) segment. At the end of 2017, Cabometyx had managed to acquire a 42% share of the second-line and new patient advanced RCC market, higher than its 39% market share at the end of the third quarter of 2017. Cabometyx demonstrated superiority over Pfizer’s (PFE) Sutent as a first-line RCC therapy in its Phase 2 CABOSUN trial in terms of progression-free survival, which has helped boost physicians’ confidence in Cabometyx.
The company reported net income of close to $115.9 million in the quarter, a YoY rise of ~594% and a sequential rise of 201%. Exelixis reported diluted GAAP (generally accepted accounting principles) EPS (earnings per share) of close to $0.37, a YoY rise of ~585% and a sequential rise of 201%. Analysts expect Exelixis to report revenue of close to $723 million in 2018, a YoY rise of ~59.8%.
European Commission approves Exelixis' (EXEL) Cabometyx 20 mg, 40 mg and 60 mg for the first-line treatment of adults with intermediate- or poor-risk renal cell carcinoma in the European Union.
On May 11, Exelixis’s (EXEL) closing price was $19.55, almost 12.9% lower than its closing price on May 4. This fall was mainly attributable to unfavorable results released from its Phase 3 IMblaze370 study comparing a combination regimen of Cotellic (cobimetinib) with Roche Holdings’ (RHHBY) Tecentriq (atezolizumab) compared to Bayer’s Stivarga in locally advanced or metastatic colorectal cancer indications. Exelixis and Roche Holdings’ investigational combination regimen failed to demonstrate a statistically significant improvement in the primary end point of overall survival compared to Stivarga in difficult-to-treat patients who had witnessed disease progression or had been unable to tolerate at least two chemotherapy treatments.
Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling the Peaks (Biotech Stocks Hitting 52-week highs on May 16) Abaxis Inc (NASDAQ: ABAX ) (announced a deal to be bought ...
On March 7, Merck (MRK) announced that it had entered a collaboration with Eisai for the co-development and co-commercialization of the latter’s oral protein tyrosine kinase inhibitor, Lenvima, as a monotherapy and in combination regimens with Keytruda in multiple oncology indications. Lenvima monotherapy is currently approved in more than 50 countries as treatment for progressive differentiated thyroid cancer patients that witness disease progression despite being treated with radioactive iodine therapy. Lenvima in combination with Novartis’s (NVS) Afinitor is approved in more than 40 countries for the second-line renal cell carcinoma indication.
Array BioPharma (ARRY) was a big mover last session, as the company saw its shares rise more than 5% on the day amid huge volumes.
Zacks.com featured highlights include: Marine Products, Nutrisystem, Exelixis, Illumina and Baxter
Exelixis stock tanked Thursday after a regimen using its drug and another from Roche failed in a late-stage study of hard-to-treat colon cancer patients.
A company with a favorable efficiency level is expected to provide stellar returns as it is believed to be positively correlated with price performance.
In April 2018, the FDA accepted for priority review Regeneron Pharmaceuticals (REGN) and Sanofi’s (SNY) Biologics License Application (or BLA) for cemiplimab for the treatment of individuals with metastatic CSCC (cutaneous squamous cell carcinoma) or individuals with locally advanced CSCC who cannot be treated with surgery. In September 2017, the FDA granted cemiplimab Breakthrough Therapy designation status for the treatment of metastatic CSCC. The FDA provided a Prescription Drug User Fee Act action date of October 28, 2018.