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News Breaks
July 9, 2014
11:57 EDTCELGCelgene shares higher despite missing primary endpoint in Otezla trial
Celgene Corporation (CELG) this morning said one of its drug, Otezla, did not achieve the primary endpoint in a Phase III trial. WHAT'S NEW: The biopharmaceutical company said Otezla, an oral treatment for adults with active psoriatic arthritis, did not achieve a statistically significant improvement when compared to placebo in its Phase III POSTURE study in patients with ankylosing spondylitis, a inflammatory spinal joint disorder. Despite missing the study's primary endpoint, Celgene said the drug did show "meaningful efficacy" in patients with early stages of the disease who took Otezla for a longer period. The company said evaluation of these efficacy results is ongoing. WHAT'S NOTABLE: Despite missing the primary endpoint, Celgene said that based on an assessment of the safety and efficacy data at week 24, an independent data monitoring committee recommended that the study proceed unchanged. Scott Smith, Global Head of Inflammation & Immunology at Celgene, says that the company is "encouraged" by its preliminary results, especially in patients with shorter disease duration. Smith said the company is planning to start another Phase III trial after it does more analysis. Celgene noted that Otezla is not approved to treat ankylosing spondylitis in any country. PRICE ACTION: Celgene shares were down as much as 1.5% earlier this morning, but are now up $1.12, or 1.31%, to $86.84 in late-morning trading. Year-to-date, shares are up nearly 3%.
News For CELG From The Last 14 Days
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November 21, 2014
06:04 EDTCELGCelgene receives positive CHMP opinion for OTEZLA
Celgene announced that the European Medicines Agency’s, or EMA, Committee for Medicinal Products for Human Use, or CHMP, has adopted a positive opinion for OTEZLA, the company’s oral selective inhibitor of phosphodiesterase 4, or PDE4, in two therapeutic indications, for the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or, who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light, or PUVA; alone or in combination with Disease Modifying Antirheumatic Drugs, or DMARD, for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
November 19, 2014
09:39 EDTCELGCelgene management to meet with ISI Group
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November 18, 2014
07:34 EDTCELGCelgene presents long-term OTEZLA data at ACR/ARHP meeting
Celgene announced that results from long-term efficacy and safety analyses of OTEZLA from the open-label phase of two PALACE phase III clinical trials were presented at the 2014 American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting in Boston. OTEZLA is the Company’s oral, selective inhibitor of phosphodiesterase 4, approved by the U.S. FDA for the treatment of adult patients with active psoriatic arthritis and for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. In PALACE 1, 84 percent of patients who completed one year of 30 mg twice daily therapy continued to receive OTEZLA at two years. Improvements in efficacy measures observed at 52 weeks were sustained through 104 weeks of treatment. At week 104, among patients receiving OTEZLA 30 mg twice daily, the ACR20 response rate was 65.3 percent. ACR50 and 70 response rates were 34.0 percent and 19.6 percent, respectively, at week 104. Similar findings were observed in PALACE 4. In this trial, nearly 84 percent of DMARD-naïve patients who completed one year of OTEZLA 30 mg twice daily monotherapy continued to receive OTEZLA at two years. At week 104, among patients treated with OTEZLA 30 mg twice daily monotherapy, an ACR20, 50 and 70 response was reached by 61.4 percent, 40.7 percent and 19.2 percent of patients, respectively. In both PALACE 1 and PALACE 4, changes in other efficacy measures—including the HAQ-DI, which assesses improvements in physical function, and swollen and tender joint counts—were also generally sustained between weeks 52 and 104 with continued OTEZLA treatment. In PALACE 4, treatment with OTEZLA in patients with pre-existing enthesitis or dactylitis, two key manifestations of psoriatic arthritis, resulted in improvements in enthesitis and dactylitis that were sustained through 104 weeks of treatment.
November 17, 2014
07:16 EDTCELGMilken Institute--Faster Cures to hold a conference
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November 14, 2014
17:07 EDTCELGSoros Fund Management gives quarterly update on stakes
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07:14 EDTCELGAmerican College of Rheumatology is holding a meeting
2014 ACR/ARHP Annual Meeting is being held in Boston on November 14-19.
November 10, 2014
07:19 EDTCELGCredit Suisse to hold a conference
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