Research Desk Line-up: Gilead Sciences Post Earnings Coverage
LONDON, UK / ACCESSWIRE / October 31, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Celgene Corp. (NASDAQ: CELG), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=CELG. The Company announced on October 28, 2017, that it presented results from the Phase-III RADIANCE™ Part B trial, evaluating the efficacy and safety of Ozanimod versus a first-line treatment, Avonex® (interferon beta-1a) (IFN), in patients with relapsing multiple sclerosis (RMS) at the MSParis2017 - 7th Joint ECTRIMS - ACTRIMS Meeting. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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Discover more of our free reports coverage from other companies within the Biotechnology industry. Pro-TD has currently selected Gilead Sciences, Inc. (NASDAQ: GILD) for due-diligence and potential coverage as the Company announced on October 26, 2017, its financial results for Q3 2017 which ended on September 30, 2017. Tune in to our site to register for a free membership, and be among the early birds that get our report on Gilead Sciences when we publish it.
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About RADIANCE™ Part B Trial
The RADIANCE™ Part B is a pivotal, Phase-III, multicenter, randomized, double-blind, double-dummy, active-controlled trial. The study evaluated the efficacy, safety, and tolerability of two doses of oral Ozanimod (1.0 mg and 0.5 mg) against IFN in 1,320 patients with RMS across 147 sites in 21 countries treated for two years.
Results of the Study
- A significant reduction in new or enlarging T2 lesions, gadolinium-enhanced MRI lesions and annualized relapse rate (ARR) was demonstrated for Ozanimod compared to IFN over two years of treatment. A reduction in brain volume loss was also observed for both Ozanimod doses compared with IFN.
- In a pre-specified pooled analysis of the SUNBEAM™ and RADIANCE™ Part B studies, Ozanimod did not reach statistical significance compared to IFN in the time to 3-month confirmed disability progression.
- Most common treatment-emergent adverse effects experienced by the patients included nasopharyngitis, headache, alanine aminotransferase increased, influenza-like illness, hypertension, gamma-glutamyl transferase increased, pharyngitis, and urinary tract infection.
- Infection rates were similar across treatment arms; serious infection rates were low and similar across treatment arms, with no serious opportunistic infections.
- The overall safety and tolerability profile was consistent with results from the previously reported Phase-II RADIANCE™ Part A and Phase-III SUNBEAM™ studies in RMS.
- In May 2017, the Phase-III RADIANCE™ trial met the primary endpoint in reducing ARR compared to weekly IFN.
Benefit-Risk Profile Supports Ozanimod as Potential New Oral Therapeutic Option
Terrie Curran, President of Celgene Inflammation and Immunology, mentioned that given the totality of the data for Ozanimod, it is believed that the benefit-risk profile supports pursuing Ozanimod as a potential new oral therapeutic option. The Company is looking forward to filing regulatory submissions in the US by the end of 2017 and in the EU in the first half of 2018.
About Ozanimod
Ozanimod is a novel, oral, investigational selective sphingosine 1-phosphate (S1P) 1 and 5 receptor modulator in development for the treatment of patients with RMS, and ulcerative colitis. Ozanimod is an investigational compound that is not approved for any use in any country.
About SUNBEAM™
SUNBEAM™ is a pivotal, Phase-III, multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety, and tolerability of two doses of oral Ozanimod (1.0 mg and 0.5 mg) versus IFN over a 12-month treatment period. The study included 1,346 people living with RMS across 152 sites in 20 countries.
About Celgene Corp.
Founded in 1986, Celgene is an integrated global pharmaceutical Company engaged primarily in the discovery, development, and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. The Company is headquartered in Summit, New Jersey.
Last Close Stock Review
At the close of trading session on Monday, October 30, 2017, Celgene's stock price climbed 2.85% to end the day at $100.97. A total volume of 16.05 million shares were exchanged during the session, which was above the 3-month average volume of 5.57 million shares. The Company's shares are trading at a PE ratio of 23.79. At Monday's closing price, the stock's net capitalization stands at $80.46 billion.
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