Celgene Corporation and Acceleron Announce Completion of Target Enrollment in MEDALIST and BELIEVE Phase 3 Studies

Celgene Corporation (NASDAQ:CELG) and Acceleron Pharma (NASDAQ:XLRN) announced that they have completed target enrollment in the MEDALIST and BELIEVE Phase 3 studies of luspatercept in patients with myelodysplastic syndromes (MDS) and beta-thalassemia. The Companies expect to report top-line results from the clinical trials in the middle of 2018. Luspatercept is being developed to treat a range of hematologic diseases including MDS, beta-thalassemia, and myelofibrosis as part of a global collaboration between Acceleron and Celgene.

“We are excited to have completed target enrollment in our MEDALIST and BELIEVE Phase 3 studies of luspatercept, ahead of schedule, and look forward to reporting top-line results in the middle of next year,” said Michael Pehl, President, Hematology and Oncology for Celgene. “Patients suffering from both diseases have limited treatment options to improve their underlying anemia. We believe that luspatercept may be a potentially paradigm-changing treatment option for patients and physicians alike.”

“The rapid pace of patient recruitment in our global Phase 3 trials reflects the clear need for new MDS and beta-thalassemia therapies that can significantly reduce or eliminate dependence on red blood cell transfusions,” said Habib Dable, President and Chief Executive Officer of Acceleron. “We are grateful for the support and dedication of the MEDALIST and BELIEVE study investigators, our patient advocacy partners, and most importantly the more than 500 patients and their families who are participating in our studies. I would also like to acknowledge the strong collaborative effort of the Celgene and Acceleron teams that led to this important achievement.”

The MEDALIST Phase 3 trial has enrolled 210 patients with lower-risk MDS. The BELIEVE Phase 3 trial has enrolled 300 patients with transfusion dependent beta-thalassemia. Patients who are currently in screening remain eligible for randomization into both Phase 3 studies. The trials will remain blinded for both the primary and secondary endpoints until the end of the 48-week treatment period for all randomized patients.

Shares of Celgene closed yesterday at $114.41, down $0.72 or -0.63%. CELG has a 1-year high of $127.64 and a 1-year low of $94.42. The stock’s 50-day moving average is $120.79 and its 200-day moving average is $119.82.

Overall, 2 research analysts have assigned a Hold rating and 12 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 $147.17 which is 28.6% above where the stock closed yesterday.

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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