Bristol-Myers Squibb Co (NYSE:BMY) announced that the European Medicines Agency (EMA) validated its type II variation application, which seeks to extend the current indications for Opdivoto include the treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after failure of prior platinum-containing therapy. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
“The high frequency of metastatic urothelial carcinoma and its relapsing nature highlight the substantial need for new treatment approaches with high and durable responses,” said Fouad Namouni, M.D., head of development, Oncology,Bristol-Myers Squibb. “We look forward to working with the EMA to potentially extend the use of Opdivo and bring the science of Immuno-Oncology to help patients in Europe fight this difficult-to-treat, advanced form of bladder cancer.”
The application primarily included data from CheckMate -275, a Phase 2, open-label, single-arm study assessing the safety and efficacy of Opdivo in patients with locally advanced unresectable or mUC that has progressed after a platinum-containing therapy. The primary endpoint in CheckMate -275 trial is objective response rate, and additional efficacy measures included durability of response and overall survival. Data from this study will be presented at the 2016 European Society for Medical Oncology Congress. (Original Source)
Shares of Bristol Myers are currently trading at $55.74, up 0.66 or 1.20%. BMY has a 1-year high of $77.12 and a 1-year low of $55.02. The stock’s 50-day moving average is $60.17 and its 200-day moving average is $67.47.
On the ratings front, Bristol Myers has been the subject of a number of recent research reports. In a report released today, Citigroup analyst Andrew Baum maintained a Buy rating on BMY, with a price target of $70, which implies an upside of 26.5% from current levels. Separately, on September 12, Jefferies’s Jeffrey Holford maintained a Hold rating on the stock and has a price target of $57.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Andrew Baum and Jeffrey Holford have a total average return of 2.8% and 7.9% respectively. Baum has a success rate of 50% and is ranked #1733 out of 4166 analysts, while Holford has a success rate of 63% and is ranked #367.
Overall, 9 research analysts have assigned a Hold rating and 6 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $70.38 which is 27% above where the stock opened today.
Bristol-Myers Squibb Co. engages in the discovery, development, licensing, manufacturing, marketing, distribution, and sale of biopharmaceutical products. Its pharmaceutical products include chemically-synthesized drugs or small molecules and an increasing portion of products produced from biological processes called biologics. Bristol-Myers biopharmaceutical research and development efforts in the affective (psychiatric) disorders, Alzheimer’s/dementia, cardiovascular, diabetes, hepatitis, HIV/Acquired Immunodeficiency Syndrome (AIDS), oncology, immunologic disorders and fibrotic disease areas.