Celgene Corporation (NASDAQ:CELG) and Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) announced each company has entered into collaboration agreements with Abbott (NYSE:ABT) to develop and commercialize companion diagnostic tests on Abbott’s m2000 RealTime System to identify isocitrate dehydrogenase (IDH) mutations in acute myeloid leukemia (AML) patients. Celgene is currently developing enasidenib (AG-221/CC-90007), an IDH2 mutant inhibitor, for the treatment of patients with relapsed or refractory AML who have an IDH2 mutation. Agios is developing AG-120, an IDH1 mutant inhibitor, for the treatment of patients with relapsed or refractory AML who have an IDH1 mutation.
IDH1 and IDH2 mutations occur in approximately 20% of AML patients. An article published online this week in the journal Leukemia(Medeiros, Leukemia 2016) concluded that advances in the understanding of the genetics underlying myeloid malignancies are driving an era of development for targeted treatments such as IDH mutant inhibitors. The authors recommend that IDH mutational analysis should become part of the routine AML diagnostic workup and repeated at relapse to identify patients who may be eligible for targeted investigational treatments currently under clinical study.
“AML is a complex and heterogeneous disease, making it difficult to treat,” said Han Myint, M.D., Vice President, Global Medical Affairs, Myeloid for Celgene. “IDH mutations lead to aberrant DNA methylation, causing a block in myeloid differentiation that leads to disease progression. Molecular profiling is important to identify genomic mutations which may have prognostic and potential treatment implications for patients with AML.”
Abbott’s m2000rt RealTime System, is a polymerase chain reaction (PCR) instrument designed to enable clinical laboratories to automate PCR and results analysis, simplifying the complex and manual steps often associated with molecular diagnostics. Both Celgene and Agios have incorporated this screening into clinical trial designs, including the recently initiated Phase 3 IDHENTIFY trial comparing enasidenib with conventional therapy in older patients with an IDH2 mutation and relapsed or refractory AML (NCT02577406).
“The field of personalized medicine is advancing at a rapid pace for a broad range of medical conditions, especially within hematology-oncology,” said Chris Bowden, M.D., chief medical officer at Agios. “Our collaboration with Abbott will provide a test to help identify AML patients with IDH mutations who are in need of treatment options.”
The m2000 system has not been FDA cleared or approved for use with enasidenib or AG-120.
Enasidenib and AG-120 have not been approved for any use in any country. (Original Source)
Shares of Celgene Corporation closed yesterday at $101.64, down $2.63 or -2.52%. 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 $107.38 and its 200-day moving average is $105.64.
On the ratings front, Celgene has been the subject of a number of recent research reports. In a report issued on October 7, Jefferies analyst Brian Abrahams reiterated a Buy rating on CELG, with a price target of $134, which represents a potential upside of 32% from where the stock is currently trading. Separately, on September 30, Piper Jaffray’s Joshua Schimmer reiterated a Buy rating on the stock and has a price target of $145.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Brian Abrahams and Joshua Schimmer have a total average return of 8.6% and -0.7% respectively. Abrahams has a success rate of 54% and is ranked #318 out of 4183 analysts, while Schimmer has a success rate of 45% and is ranked #3315.
The street is mostly Bullish on CELG stock. Out of 20 analysts who cover the stock, 17 suggest a Buy rating and 3 recommend to Hold the stock. The 12-month average price target assigned to the stock is $137.50, which implies an upside of 35.3% from current levels.
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.