Company Update (NASDAQ:CELG): Celgene Corporation Announces Interim Topline Data from Trial of Investigational Oral GED-0301 in Patients with Active Crohn’s Disease

Celgene Corporation (NASDAQ:CELG) 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.”

“At this early 12-week timepoint, we’re looking at the proportion of patients who had a 25 percent or greater endoscopic improvement, suggesting mucosal healing is underway in these patients,” said Dr. William Sandborn, M.D., Professor of Medicine and Chief, Division of Gastroenterology and Director, University of California San Diego Inflammatory Bowel Disease Center. “These data support the notion that GED-0301, a potential first-in-class oral antisense therapy, may target an underlying cause of Crohn’s disease, rather than simply improving symptoms.”

Full data from the 12-week timepoint have been submitted for presentation at an upcoming scientific meeting later this year. The CD-001 study is ongoing until all patients complete the observation phase. Data from the observation portion of the trial are expected in 2017. The Phase III registration program is ongoing. (Original Source)

Shares of Celgene closed last Friday at $104.47, down $3.18 or -2.95%. CELG has a 1-year high of $128.39 and a 1-year low of $93.05. The stock’s 50-day moving average is $110.83 and its 200-day moving average is $104.82.

On the ratings front, Celgene has been the subject of a number of recent research reports. In a report issued on September 8, Morgan Stanley analyst Matthew Harrison reiterated a Hold rating on CELG, with a price target of $120, which represents a potential upside of 14.9% from where the stock is currently trading. Separately, on September 7, Jefferies’s Brian Abrahams reiterated a Buy rating on the stock .

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Matthew Harrison and Brian Abrahams have a total average return of 2.7% and 3.6% respectively. Harrison has a success rate of 52.1% and is ranked #1165 out of 4124 analysts, while Abrahams has a success rate of 50.0% and is ranked #723.

Overall, 3 research analysts have assigned a Hold rating and 15 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $140.86 which is 34.8% above where the stock closed last Friday.

Celgene Corp. is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. Its targeting areas include intracellular signaling pathways, protein homeostasis and epigenetics in cancer and immune cells, immunomodulation in cancer and autoimmune diseases and therapeutic application of cell therapies. The company’s products include Revlimid, Vidaza, Thalomid, Pomalyst/Imnovid, Abraxane, and Istodax. 

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