Celgene Corporation (NASDAQ:CELG) announced that its phase III SUNBEAM trial, evaluating the efficacy and safety of ozanimod, an investigational oral, selective S1P 1 and 5 receptor modulator, in patients with relapsing multiple sclerosis (RMS), met the primary endpoint in reducing annualized relapse rate (ARR), compared to weekly interferon (IFN) β-1a (Avonex®).
SUNBEAM evaluated two orally administered treatment doses (0.5 mg and 1 mg) of ozanimod, with patients treated for at least one year. The randomized phase III trial enrolled 1,346 RMS patients in 20 countries.
Top-line data show that both the ozanimod 1 mg and 0.5 mg treatment arms demonstrated statistically significant and clinically meaningful improvements compared to Avonex® for the primary endpoint of ARR and the measured secondary endpoints of the number of gadolinium-enhancing MRI lesions and the number of new or enlarging T2 MRI lesions at month 12. As agreed to in the Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration, a pre-specified analysis on the time to onset of disability progression will be conducted using pooled results from both the SUNBEAM and RADIANCE phase III trials.
The overall safety and tolerability profile was consistent with results from previously reported phase II RMS (RADIANCE) and phase II ulcerative colitis (TOUCHSTONE) trials.
“The safety and efficacy results from SUNBEAM are consistent with the long-term results from the phase II trial (RADIANCE). These data add to the growing body of evidence supporting the use of ozanimod as a disease modifying therapy for relapsing forms of multiple sclerosis,” said Bruce Cree, Associate Professor of Neurology, Multiple Sclerosis Center, Department of Neurology, University of California San Francisco. “We look forward to the continued study of ozanimod as well as presentation of the full results of the phase III trial at an upcoming international scientific meeting.”
“People living with multiple sclerosis need additional therapies and we are pleased that oral ozanimod showed meaningful improvements across primary and measured secondary endpoints in this study,” said Scott Smith, President of Celgene Inflammation and Immunology. “We look forward to data from the confirmatory phase III RADIANCE trial in the second quarter as we advance toward planned regulatory submissions by year-end.”
Shares of Celgene Corporation closed yesterday at $118.66, down $1.81 or -1.50%. CELG has a 1-year high of $127 and a 1-year low of $94.39. The stock’s 50-day moving average is $116.21 and its 200-day moving average is $111.96.
On the ratings front, Celgene has been the subject of a number of recent research reports. In a report released yesterday, Canaccord analyst John Newman reiterated a Buy rating on CELG, with a price target of $156, which represents a potential upside of 31% from where the stock is currently trading. On January 27, Jefferies’ Brian Abrahams maintained a Buy rating on the stock and has a price target of $142.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, John Newman and Brian Abrahams have a yearly average loss of -10.7% and a return of 9.2% respectively. Newman has a success rate of 34% and is ranked #4389 out of 4459 analysts, while Abrahams has a success rate of 51% and is ranked #469.
Sentiment on the street is mostly bullish on CELG stock. Out of 16 analysts who cover the stock, 14 suggest a Buy rating and 2 recommend to Hold the stock. The 12-month average price target assigned to the stock is $142.43, which represents a potential upside of 20% from where the stock is currently trading.
Celgene Corp. is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. Its targeting areas include intracellular signaling pathways, protein homeostasis and epigenetics in cancer and immune cells, immunomodulation in cancer and autoimmune diseases and therapeutic application of cell therapies. The company’s products include Revlimid, Vidaza, Thalomid, Pomalyst/Imnovid, Abraxane, and Istodax.