Incyte Corporation (NASDAQ:INCY) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ruxolitinib (Jakafi®) for the treatment of patients with acute graft-versus-host disease (GVHD). There are currently no approved treatments for patients with acute GVHD.
Breakthrough Therapy Designation is designed to expedite the development and review of drugs for serious or life-threatening conditions and to help ensure people have access to them through FDA approval as soon as possible. The criteria for awarding Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have clinically significant improvement over available therapy.
“Receiving Breakthrough Therapy Designation from the FDA recognizes the severe nature of acute GVHD, the clear unmet medical need of these patients, and the potential, based on clinical evidence to-date, for ruxolitinib to address the urgent needs of patients with this life-threatening disease,” said Steven Stein, M.D., Incyte’s Chief Medical Officer. “We are committed to working closely with the FDA in an effort to bring ruxolitinib to patients with GVHD as soon as possible.”
In March 2016, Incyte and Lilly agreed to amend their License, Development and Commercialization Agreement to enable Incyte to independently develop and commercialize ruxolitinib for GVHD. In April 2016, Incyte andNovartis also agreed to amend their Collaboration and License Agreement, granting Novartis the rights to research, develop and commercialize ruxolitinib for GVHD outside the U.S. (Original Source)
Shares of Incyte are up nearly 3% to $80.90 in pre-market trading. INCY has a 1-year high of $133.62 and a 1-year low of $55. The stock’s 50-day moving average is $78.61 and its 200-day moving average is $80.58.
On the ratings front, Incyte has been the subject of a number of recent research reports. In a report issued on June 14, JMP analyst Liisa Bayko reiterated a Buy rating on INCY, with a price target of $100, which implies an upside of 27.4% from current levels. Separately, on June 7, BMO’s Ian Somaiya reiterated a Buy rating on the stock and has a price target of $97.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Liisa Bayko and Ian Somaiya have a total average return of 14.6% and 13.9% respectively. Bayko has a success rate of 49.1% and is ranked #322 out of 3980 analysts, while Somaiya has a success rate of 52.7% and is ranked #219.
Overall, 9 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 $97.50 which is 24.2% above where the stock closed yesterday.
Incyte Corp. is a biopharmaceutical company, which focuses on the discovery, development, development, formulation, manufacturing and commercialization of proprietary therapeutics to treat serious unmet medical needs, primarily in oncology. Its product, Jakafi, a JAK1 and JAK2 inhibitor, is currently approved in the U.S. for the treatment of intermediate or high-risk myelofibrosis and is in development as a potential treatment for other cancers.