Bristol-Myers Squibb Co (NYSE:BMY) announced that the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA), which seeks to expand the use ofOpdivo to patients with locally advanced unresectable or metastatic urothelial carcinoma (mUC) that has progressed on or after platinum-containing therapy. The FDA granted the application priority review and previously granted Opdivo Breakthrough Therapy Designation for mUC in June 2016, reinforcing the need for new treatment approaches in this patient population. The FDA action date is March 2, 2017.
“We are pleased that the FDA has accepted our application for Opdivo in previously treated patients with metastatic urothelial carcinoma, an advanced form of bladder cancer,” said Vicki Goodman, M.D., development lead, Melanoma and Genitourinary Cancers, Bristol-Myers Squibb. “We look forward to working with regulatory authorities to potentially bring Opdivo to this patient community, which has historically had limited treatment options.”
The submission was based on data from CheckMate -275, a Phase 2, single-arm clinical trial evaluating the safety and efficacy of Opdivo in 270 patients with metastatic or unresectable urothelial carcinoma that has progressed or recurred following treatment with a platinum-based agent in the metastatic setting or within one year after neoadjuvant/adjuvant platinum therapy. The primary endpoint in the trial was confirmed objective response rate (ORR) based on assessments by the blinded independent review committee. Key secondary endpoints included progression-free survival (PFS), overall survival (OS), safety and quality of life. Data from this study was recently presented at the 2016 European Society for Medical Oncology Congress. (Original Source)
Shares of Bristol Myers are currently trading at $50.00, down $0.36 or -0.71%. BMY has a 1-year high of $77.12 and a 1-year low of $49.10. The stock’s 50-day moving average is $54.01 and its 200-day moving average is $65.43.
On the ratings front, Bristol Myers has been the subject of a number of recent research reports. In a report issued on October 19, Jefferies analyst Jeffrey Holford reiterated a Hold rating on BMY, with a price target of $54, which implies an upside of 8% from current levels. Separately, on October 17, Credit Suisse’s Vamil Divan maintained a Hold rating on the stock and has a price target of $58.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jeffrey Holford and Vamil Divan have a total average return of 6.1% and 8.9% respectively. Holford has a success rate of 54.5% and is ranked #509 out of 4183 analysts, while Divan has a success rate of 47% and is ranked #441.
The street is mostly Neutral on BMY stock. Out of 16 analysts who cover the stock, 10 suggest a Hold rating and 6 recommend to Buy the stock. The 12-month average price target assigned to the stock is $67.80, which represents a potential upside of 35% from where the stock is currently trading.
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.