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Celgene (CELG) Multiple Sclerosis Drug Meets Primary Endpoint
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Celgene Corporation announced positive results from the phase III trial, RADIANCE that evaluated the efficacy and safety of experimental candidate ozanimod.
Celgene’s share price movement shows that the stock has outperformed the Zacks classified Medical-Biomedical and Genetics industry in the past year. Specifically, the stock gained 13.4% during this period, against the industry’s decline of 9.7%.
The candidate was being evaluated for the treatment of relapsing multiple sclerosis (RMS).
The results from the trial showed that the candidate met the primary endpoint in reducing annualized relapse rate (ARR), compared to weekly interferon (IFN) β-1a (Avonex).
The trial evaluated two doses (0.5 mg and 1 mg) of oral ozanimod, with patients who have been treated for two years. The results showed that both ozanimod 0.5 mg and 1 mg doses demonstrated statistically significant and clinically meaningful reductions in the primary endpoint of ARR and the key secondary endpoints of the number of new or enlarging T2 MRI lesions over 24 months of treatment compared to Avonex and the number of gadolinium-enhancing MRI lesions at 24 months of treatment compared to Avonex.
The overall safety and tolerability profile was consistent with results from the recently completed phase III SUNBEAM RMS trial. The company is evaluating the results further. We note that in Feb 2017, Celgene announced positive top-line results from the second active comparator phase III trial, SUNBEAM, in RMS.
Results from both the trials will be presented at an upcoming medical congress. Meanwhile, Celgene expects to submit a New Drug Application to the FDA by the end of 2017, based on the combined data from the SUNBEAM and RADIANCE trials.
The Aug 2015 Receptos acquisition added its lead candidate, ozanimod, to Celgene's pipeline.
Meanwhile, Celgene’s key growth driver, Revlimid, continues to outperform on the back of market share gains and increased duration. However, Otezla sales in the first quarter were impacted by managed care dynamics that drove lower total marketplace prescriptions for psoriasis therapies in the first quarter.
VIVUS’ loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 60 days. The company posted positive earnings surprises in all of the four trailing quarters, with an average beat of 233.69%.
Aldeyra’s loss per share estimates narrowed from $1.86 to $1.69 cents for 2017 over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters, with an average beat of 7.8%.
Zoetis’ earnings per share estimates increased from $2.32 to $2.34 for 2017 over the last 60 days. The company posted positive earnings surprises in all four trailing quarters, with an average beat of 9.82%.
Zacks' 2017 IPO Watch List
Before looking into the stocks mentioned above, you may want to get a head start on potential tech IPOs that are popping up on Zacks' radar. Imagine being in the first wave of investors to jump on a company with almost unlimited growth potential? This Special Report gives you the current scoop on 5 that may go public at any time.
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Celgene (CELG) Multiple Sclerosis Drug Meets Primary Endpoint
Celgene Corporation announced positive results from the phase III trial, RADIANCE that evaluated the efficacy and safety of experimental candidate ozanimod.
Celgene’s share price movement shows that the stock has outperformed the Zacks classified Medical-Biomedical and Genetics industry in the past year. Specifically, the stock gained 13.4% during this period, against the industry’s decline of 9.7%.
The candidate was being evaluated for the treatment of relapsing multiple sclerosis (RMS).
The results from the trial showed that the candidate met the primary endpoint in reducing annualized relapse rate (ARR), compared to weekly interferon (IFN) β-1a (Avonex).
The trial evaluated two doses (0.5 mg and 1 mg) of oral ozanimod, with patients who have been treated for two years. The results showed that both ozanimod 0.5 mg and 1 mg doses demonstrated statistically significant and clinically meaningful reductions in the primary endpoint of ARR and the key secondary endpoints of the number of new or enlarging T2 MRI lesions over 24 months of treatment compared to Avonex and the number of gadolinium-enhancing MRI lesions at 24 months of treatment compared to Avonex.
The overall safety and tolerability profile was consistent with results from the recently completed phase III SUNBEAM RMS trial. The company is evaluating the results further. We note that in Feb 2017, Celgene announced positive top-line results from the second active comparator phase III trial, SUNBEAM, in RMS.
Results from both the trials will be presented at an upcoming medical congress. Meanwhile, Celgene expects to submit a New Drug Application to the FDA by the end of 2017, based on the combined data from the SUNBEAM and RADIANCE trials.
The Aug 2015 Receptos acquisition added its lead candidate, ozanimod, to Celgene's pipeline.
Meanwhile, Celgene’s key growth driver, Revlimid, continues to outperform on the back of market share gains and increased duration. However, Otezla sales in the first quarter were impacted by managed care dynamics that drove lower total marketplace prescriptions for psoriasis therapies in the first quarter.
Zacks Rank & Key Picks
Celgene currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the health care sector include VIVUS, Inc. , Aldeyra Therapeutics, Inc. (ALDX - Free Report) and Zoetis Inc. (ZTS - Free Report) . While VIVUS sports a Zacks Rank #1 (Strong Buy), Aldeyra and Zoetis carry a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks Rank #1 stocks here.
VIVUS’ loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 60 days. The company posted positive earnings surprises in all of the four trailing quarters, with an average beat of 233.69%.
Aldeyra’s loss per share estimates narrowed from $1.86 to $1.69 cents for 2017 over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters, with an average beat of 7.8%.
Zoetis’ earnings per share estimates increased from $2.32 to $2.34 for 2017 over the last 60 days. The company posted positive earnings surprises in all four trailing quarters, with an average beat of 9.82%.
Zacks' 2017 IPO Watch List
Before looking into the stocks mentioned above, you may want to get a head start on potential tech IPOs that are popping up on Zacks' radar. Imagine being in the first wave of investors to jump on a company with almost unlimited growth potential? This Special Report gives you the current scoop on 5 that may go public at any time.
One has driven from 0 to a $68 billion valuation in 8 years. Four others are a little less obvious but already show jaw-dropping growth. Download this IPO Watch List today for free >>