Bristol-Myers Partners Array To Investigate Cancer Candidate
Zacks Investment Research | May 30, 2017 11:13PM ET
Bristol-Myers Squibb Company (NYSE:BMY) and Array BioPharma (NASDAQ:ARRY) entered into a clinical research collaboration to investigate the safety, tolerability and efficacy of Array's binimetinib in combination with Bristol-Myers Squibb's Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen. The combination will be assessed to treat metastatic colorectal cancer in patients with microsatellite stable tumors.
Bristol-Myers’ shares have lost 7.7% year to date against the Zacks classified Large Cap Pharmaceuticals industry’s gain of 9.1%.
Binimetinib is an investigational MEK inhibitor that is being studied in clinical trials in advanced cancer patients, including the phase III COLUMBUS trial in patients with BRAF-mutant melanoma and the phase III BEACON CRC trial in patients with BRAF V600E-mutant colorectal cancer.
The phase I/II study is anticipated to begin in the second half of 2017, and the results from this study will be used to determine optimal approaches to advance the development of these combinations. The study will evaluate the preliminary anti-tumor activity of combining binimetinib with Opdivo as well as binimetinib in combination with the Opdivo + Yervoy regimen. Per the agreement, Array and Bristol-Myers Squibb will jointly support the study sponsored by the former.
However, we remind investors that in Mar 2017, Array withdrew its new drug application (NDA) for its binimetinib, from the FDA’s Division of Oncology Products 2. The candidate was being evaluated as a monotherapy for the treatment of NRAS-mutant melanoma, a rare, mutationally-driven subset of skin cancer.
In fact, the decision to withdraw the NDA was based on thorough discussions with the FDA, following late cycle review meeting held with agency. According to the feedback received from the FDA, the clinical benefit demonstrated in the phase III NEMO study was not sufficient to support the NDA for that indication. Nonetheless, the action will not impact the other ongoing trial on the drug.
Recently, Bristol-Myers also collaborated with Advaxis, Inc. (NASDAQ:ADXS) to evaluate ADXS-DUAL, an investigational immunotherapy targeting HPV-associated cancers, and the former’s Opdivo, as a potential combination treatment option for women with metastatic cervical cancer. The study is expected to start by the end of 2017 and will assess this combination regimen in women with persistent, recurrent or metastatic (squamous or non-squamous cell) carcinoma of the cervix who have failed at least one prior line of systemic chemotherapy.
Get The News You Want
Bristol-Myers Squibb Company Price
Bristol-Myers Squibb Company Quote
Zacks Rank & Stock to Consider
Both Bristol-Myers and Array carry a Zacks Rank #3 (Hold). Another better-ranked stock in the health care sector is VIVUS, Inc. (NASDAQ:VVUS) sporting a Zacks Rank #1 (Strong Buy). You can see .
VIVUS’ loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 30 days. The company posted positive earnings surprises in all of the four trailing quarters with an average beat of 233.69%.
More Stock News: 8 Companies Verge on Apple-Like Run
Did you miss Apple (NASDAQ:AAPL)'s 9X stock explosion after they launched their iPhone in 2007? Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs. A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Zacks Investment Research
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.