Exelixis, Inc. (NASDAQ:EXEL) announced positive overall survival (OS) results from coBRIM, the phase 3 pivotal trial evaluating cobimetinib, a specific MEK inhibitor discovered byExelixis, in combination with vemurafenib in previously untreated patients with unresectable locally advanced or metastatic melanoma carrying a BRAF V600 mutation. Exelixis’ collaborator Genentech, a member of the Roche Group, informed the company that coBRIM met its secondary endpoint of demonstrating a statistically significant and clinically meaningful increase in overall survival for patients receiving the combination of cobimetinib and vemurafenib, as compared to vemurafenib monotherapy. Ongoing study monitoring did not identify any new safety signals. Long-term safety data are expected later this year. These data will be the subject of a presentation at an upcoming medical meeting.
“The positive effect of the combination of cobimetinib and vemurafenib on overall survival is a major step forward for patients with advanced BRAF V600 mutation-positive melanoma in search of new treatment options,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “We continue to work with our partners at Genentech in preparation for the potential U.S. approval and launch of cobimetinib to deliver this important potential treatment option to patients, physicians and caregivers in the United States as quickly as possible.”
Exelixis announced the first regulatory approval of cobimetinib in Switzerland in August 2015. U.S. and EU regulatory applications sponsored by Genentech and Roche, respectively, are currently under review. In the United States, the Prescription Drug User Fee Act action date is November 11, 2015. In the EU, Roche anticipates a regulatory decision by the end of this year following a positive opinion from the European Committee for Medicinal Products for Human Use announced in late September. (Original Source)
Shares of Exelixis closed yesterday at $5.90. EXEL has a 1-year high of $6.81 and a 1-year low of $1.26. The stock’s 50-day moving average is $5.85 and its 200-day moving average is $4.29.
On the ratings front, Exelixis has been the subject of a number of recent research reports. In a report issued on September 28, Cowen analyst Eric Schmidt reiterated a Buy rating on EXEL. Separately, on September 18, William Blair’s John Sonnier reiterated a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Eric Schmidt and John Sonnier have a total average return of 33.0% and 16.7% respectively. Schmidt has a success rate of 56.5% and is ranked #46 out of 3770 analysts, while Sonnier has a success rate of 56.8% and is ranked #334.
Exelixis Inc is a biotechnology company that develops small molecule therapies for the treatment of cancer.