Agios Pharmaceuticals Inc (NASDAQ:AGIO), a leader in the fields of cancer metabolism and rare genetic disorders of metabolism, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AG-120 for the treatment of patients with acute myelogenous leukemia (AML) who harbor an isocitrate dehydrogenase-1 (IDH1) mutation. AG-120 is a first-in-class, oral, selective, potent inhibitor of the mutated IDH1 protein being evaluated in two Phase 1 clinical trials, one in hematologic malignancies that recently initiated three expansion cohorts, and one in advanced solid tumors, including glioma.
“We are pleased that now both AG-120 and AG-221 have been granted Fast Track designation, demonstrating theFDA’s commitment to facilitate the development and expedite the review of our lead IDH programs as important new therapies for people with AML who carry these mutations,” said Chris Bowden, M.D., chief medical officer of Agios. “We look forward to presenting new data from the ongoing Phase 1 study at the EHA Annual Congress next month and remain on track to initiate a global, registration-enabling Phase 3 study in collaboration with Celgene in AML patients who harbor an IDH1 mutation in the first half of 2016.”
The FDA’s Fast Track Drug Development Program is designed to expedite clinical development and submission of New Drug Applications (NDA) for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs. Specifically, Fast Track designation facilitates frequent interactions with the FDA review team, including meetings to discuss all aspects of development to support approval, and also provides the opportunity to submit sections of an NDA on a rolling basis as data become available. (Original Source)
Shares of Agios closed last Friday at $112.78 . AGIO has a 1-year high of $138.85 and a 1-year low of $31.51. The stock’s 50-day moving average is $101.45 and its 200-day moving average is $105.69.
On the ratings front, Agios has been the subject of a number of recent research reports. In a report issued on May 8, MLV & Co. analyst Arlinda Lee maintained a Buy rating on AGIO, with a price target of $130, which represents a potential upside of 15.3% from where the stock is currently trading. Separately, on May 7, Canaccord Genuity’s John Newman maintained a Hold rating on the stock and has a price target of $103.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Arlinda Lee and John Newman have a total average return of 1.1% and 6.5% respectively. Lee has a success rate of 48.1% and is ranked #2028 out of 3604 analysts, while Newman has a success rate of 53.3% and is ranked #795.
Agios Pharmaceuticals Inc is engaged in the development of medicines to treat cancer metabolism and inborn errors of metabolism, which are a subset of orphan genetic metabolic diseases.