Following the recommendation by an independent Data Monitoring Committee (DMC), Gilead Sciences, Inc. (NASDAQ:GILD) announced that its Phase 3 Study 115 evaluating Zydelig® (idelalisib) added to standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients will be unblinded early. The DMC recommendation is based upon a predefined interim analysis indicating a statistically significant benefit in efficacy for progression-free survival (PFS) and overall survival (OS) in patients receiving Zydelig plus bendamustine and rituximab, compared to those receiving only bendamustine and rituximab. The safety profile of Zydelig was consistent with prior studies. Detailed results from this study will be presented during a late-breaking abstracts session (#LBA-5) at the Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida taking place December 5-8.
Zydelig is approved in the United States in combination with rituximab for patients with relapsed CLL for whom rituximab alone would be considered appropriate therapy due to comorbidities.
“The clinical benefit observed in this Phase 3 study adds to the body of evidence demonstrating the potential of Zydelig-containing treatment regimens for patients with previously treated CLL,” said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “We look forward to sharing the detailed scientific data with the hematology community at the upcoming ASH meeting.”
Study 115 is a randomized, double-blind, placebo-controlled, Phase 3 study evaluating the efficacy and safety of Zydelig in combination with bendamustine and rituximab among 416 adult patients with previously treated CLL. Eligible patients were randomized (1:1) to receive six cycles of bendamustine and rituximab over 24 weeks combined with either Zydelig 150 mg or placebo taken orally twice daily continuously until disease progression or unacceptable toxicity. The primary endpoint is PFS. (Original Source)
Shares of Gilead Sciences closed last Friday at $102.57. GILD has a 1-year high of $123.37 and a 1-year low of $85.95. The stock’s 50-day moving average is $103.63 and its 200-day moving average is $109.64.
On the ratings front, Gilead has been the subject of a number of recent research reports. In a report issued on November 13, Maxim Group analyst Jason Kolbert reiterated a Buy rating on GILD, with a price target of $137, which represents a potential upside of 33.6% from where the stock is currently trading. Separately, on November 5, Piper Jaffray’s Joshua Schimmer upgraded the stock to Buy .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Joshua Schimmer have a total average return of -13.5% and -2.9% respectively. Kolbert has a success rate of 27.7% and is ranked #3835 out of 3842 analysts, while Schimmer has a success rate of 36.8% and is ranked #3480.
Overall, 2 research analysts have assigned a Hold rating and 9 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 $132.67 which is 29.3% above where the stock closed last Friday.
