Bristol-Myers Squibb Co (NYSE:BMY) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Opdivo (nivolumab) for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin. The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
“We recognize the enormous challenges facing classical Hodgkin lymphoma patients who do not respond to or who progress following currently available treatments, and we are dedicated to helping these patients in their fight against this devastating disease,” said Emmanuel Blin, senior vice president and chief strategy officer, Bristol-Myers Squibb. “Today’s CHMP positive opinion marks an important milestone in applying our Immuno-Oncology science to delivering a treatment option for patients with this hematologic malignancy. If approved by the European Commission, Opdivo will become the first PD-1 inhibitor approved to treat a hematologic malignancy in the European Union, further building on our established heritage in blood cancer care.”
The CHMP positive opinion is based on data from the Phase 2 CheckMate -205 and the Phase 1 CheckMate -039 trials, evaluating patients with relapsed or refractory cHL after ASCT and treatment with brentuximab vedotin. These results showed Opdivo delivered an objective response rate, as assessed by an independent radiologic review committee, of 66%. In CheckMate -205 and -039, among all patients (safety population: n=263), the most common adverse events (reported in at least 20%) were fatigue (32.3%), diarrhea (28.9%), pyrexia (27.1%) and cough (25.9%). (Original Source)
Shares of Bristol Myers Squibb closed yesterday at $50.24, up $0.23 or 0.46%. BMY has a 1-year high of $77.12 and a 1-year low of $49.12. The stock’s 50-day moving average is $56.24 and its 200-day moving average is $67.14.
On the ratings front, BMY has been the subject of a number of recent research reports. In a report issued on October 10, Leerink analyst Seamus Fernandez reiterated a Buy rating on the stock, while BMO’s Alex Arfaei maintained a Hold rating.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Seamus Fernandez and Alex Arfaei have a total average return of 3.7% and 5.8% respectively. Fernandez has a success rate of 52% and is ranked #957 out of 4182 analysts, while Arfaei has a success rate of 62% and is ranked #654.
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 $69.40, which represents a potential upside of 38% 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.