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July 9, 2014
07:04 EDTCELGCelgene says OTEZLA did not achieve primary endpoint in Phase III trial
Celgene Corporation announced results of its phase III POSTURE study evaluating OTEZLA, the company’s oral, selective inhibitor of phosphodiesterase 4, in patients with active ankylosing spondylitis. The OTEZLA arms did not achieve statistically significant improvement versus the placebo arm for the primary endpoint, the percentage of patients who achieve an ASAS 20 response at week 16. However, in a prespecified analysis, meaningful efficacy was observed at Week 24 in a large subset of patients with early-stage disease. Evaluation of the efficacy results is ongoing. An independent data monitoring committee recommended that the study proceed unchanged, based on an assessment of the safety and efficacy data at week 24. According to the protocol, magnetic resonance imaging data will be collected in a subgroup of subjects at week 52 and at additional time points, and radiographs will be taken on all study patients at week 104 and at additional time points. The safety and tolerability data observed in the POSTURE study are consistent with previously reported phase II data in ankylosing spondylitis, as well as six phase III studies of OTEZLA in psoriatic arthritis or psoriasis. No new safety signals were observed. The evaluation of safety and efficacy in the treatment arms is ongoing and the results of the study will be presented at an upcoming medical meeting. These results are from an investigational phase III study. OTEZLA is not approved for the treatment of patients with ankylosing spondylitis in any country.
News For CELG From The Last 14 Days
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November 22, 2015
13:21 EDTCELGAlphabet, Celgene, others could rise 20% over next year, Barron's says
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November 20, 2015
10:52 EDTCELGFDA approves new oral medication to treat multiple myeloma
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November 17, 2015
08:22 EDTCELGSignificant Celgene overhang removed, says JMP Securities
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November 16, 2015
13:11 EDTCELGCelgene jumps 2% after defeating Kyle Bass patent challenge
Shares of Celgene moved higher after the U.S. Patent and Trademark Office declined to review a Revlimid patent expiring in 2019. The USPTO found that that Bass's Coalition for Affordable Drugs was unlikely to succeed, according to Bloomberg. Shares of Celgene are up 2%, or $1.64, to $190.13 in afternoon trading. The agency is reviewing two other patents on the drug.
13:08 EDTCELGCelgene defeats Bass challenege on Revlimid patent, Bloomberg reports
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November 13, 2015
11:02 EDTCELGCelgene calls active on renewed takeover chatter
Celgene November weekly 111 and 112 calls are active on total call volume of 9K contracts (3K puts) on renewed takeover chatter. November weekly call option implied volatility is at 82, November is at 42, December is at 35; compared to its 52-week range of 23 to 54. Active call volume suggests traders taking positions for large price movement.
10:58 EDTCELGRumor: Celgene moves up on renewed takeover chatter
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