Shares of Celgene Corporation (NASDAQ:CELG) ended Friday session in green amid volatile trading. The shares closed up +1.19 points or 1.11% at $108.54 with 5.92 million shares getting traded. Post opening the session at $107.13, the shares hit an intraday low of $106.70 and an intraday high of $108.88 and the price vacillated in this range throughout the day. The company has a market cap of $85.06 billion and the numbers of outstanding shares have been calculated to be 775.11 million shares.
Celgene Corporation (CELG) on September 12, 2016 announced interim topline data from a randomized, double-blind, multicenter, exploratory phase 1b study evaluating the effects of oral GED-0301 (mongersen) on both endoscopic and clinical outcomes in patients with active Crohn’s disease.
The trial, CD-001, is an ongoing study evaluating three different treatment regimens of GED-0301 in a 12-week treatment phase, followed by an observation phase up to 52 weeks (off treatment). The primary objective of the study is to explore the effect of GED-0301 on endoscopic outcomes. The trial enrolled a total of 63 patients across multiple countries.
The study was designed to further enhance the understanding of GED-0301 activity in a difficult-to-treat, moderate-to-severe patient population. This population was more diverse than prior GED-0301 studies and included patients with endoscopically confirmed mucosal damage at entry and those who had previous surgeries. The study also included both biologic exposed and biologic naïve patients as well as patients with a diagnosis of Ileitis, Ileocolitis or colitis.
Topline data from CD-001 show that in a proportion of patients treated with oral GED-0301 there was endoscopic improvement (defined as a 25 percent improvement from baseline) and clinical response and remission across all treatment groups at week 12. Findings to date reveal no new safety signals and tolerability is consistent with earlier studies.
“Given the high unmet need in Crohn’s disease, we are pleased that oral GED-0301 showed both endoscopic improvements and clinically meaningful responses and remission at an early timepoint in this study,” said Scott Smith, President of Celgene Inflammation and Immunology. “These data are particularly encouraging for several reasons, including the difficult-to-treat patient population evaluated in the trial.”
Shares of Medivation Inc (NASDAQ:MDVN) ended Friday session in red amid volatile trading. The shares closed down -0.18 points or -0.22% at $80.87 with 5.72 million shares getting traded. Post opening the session at $81.04, the shares hit an intraday low of $80.87 and an intraday high of $81.09 and the price vacillated in this range throughout the day. The company has a market cap of $13.39 billion and the numbers of outstanding shares have been calculated to be 165.93 million shares.
Medivation Inc (MDVN) on August 09, 2016 reported its financial results for the quarter ended June 30, 2016 and reaffirmed full-year 2016 financial guidance.
U.S. net sales of XTANDI® (enzalutamide) capsules, as recorded by Astellas, were $330.3 million for the quarter ended June 30, 2016, an increase of $31.8 million (+11% compared to the second quarter of 2015). The year-over-year net sales growth was driven by an 18% increase in underlying demand, partially offset by a lower net selling price resulting from a higher gross-to-net rate. Ex-U.S. net sales of XTANDI, as recorded by Astellas, were approximately $265 million for the quarter, an increase of $76 million (+41% compared to the second quarter of 2015).
“For the second consecutive quarter, XTANDI was the leading novel hormonal agent in the U.S. We continue to see increases in duration of therapy and new patient starts as well as accelerating uptake in the urology market,” said David Hung, M.D., Founder, President and Chief Executive Officer of Medivation. “In addition, we anticipate a very exciting second half of 2016 for XTANDI as we prepare commercially for the October 22 PDUFA date for a potential U.S. label amendment to include head-to-head data of enzalutamide versus bicalutamide. We also expect top-line results from our Phase II ER/PR positive breast cancer trial and our PLATO trial before year end. Looking ahead into next year, we anticipate the completion of enrollment for PROSPER, our Phase III trial in non-metastatic castration-resistant prostate cancer, as well as potentially top-line results from this study.”