A major catalyst is coming up for Bristol-Meyers Squibb's (BMY) experimental chemotherapy, ipilimumab, in 2 days!!!
I know I don't usually invest in large cap pharmas but BMY's investigational drug has the potential to gain FDA's approval as a first in class therapy for advanced skin cancer as soon as this coming Friday. BMY's ipilimumab modulates the body's immune system through a novel mechanism to attack tumor cells. In the latest clinical trial, ipilimumab extended cancer patients' lives by nearly 4 months compared to the control. This is remarkable given that these are late stage (unresectable stage III or IV) melanoma patients with poor prognosis who had received multiple treatments before. It is also the first time that a drug shows increased survival in this patient population in a phase III study. While the end point of the trial, improved survival, was met, there were more side effects including colitis, gastrointestinal irritation, diarrhea, skin rash, and 14 deaths out of 403 patients compared to the control arm.
Catalyst: PDUFA 2011-03-26
What to do?
Based on the need for a new treatment for a severe disease such as advanced melanoma, I believe that the efficacy demonstrated by ipilimumab, despite having characteristic side effects, is sufficient for the drug to pass FDA's strict standard and gain an approval. I'm planning to purchase Apr $26 call and hold through the catalyst.
