Incyte Corporation (NASDAQ:INCY) and Eli Lilly and Co (NYSE:LLY) announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the new drug application (NDA) for investigational baricitinib, a once-daily oral medication for the treatment of moderate to severe rheumatoid arthritis (RA). The NDA for baricitinib was submitted to the FDA in January 2016.
The FDA extended the action date to allow time to review additional data analyses recently submitted by Lilly in response to the FDA’s Information Requests. The submission of the additional information has been determined by the FDA to constitute a Major Amendment to the NDA, resulting in an extension of the Prescription Drug User Fee Act (PDUFA) goal date by three months.
“At Lilly, we are committed to improving the lives of people with life-long chronic diseases such as rheumatoid arthritis, a serious and disabling type of arthritis,” said J. Anthony Ware, M.D., senior vice president, product development and interim president of Lilly Bio-Medicines. “We will continue to work closely with the FDA throughout the review process and we believe that baricitinib has the potential to be an effective treatment choice, especially for those patients for whom current therapies are not adequately addressing their disease.”
This delay does not affect Lilly’s previously-issued financial guidance for 2017.
Shares of Incyte are currently trading at $117.75 in pre-market trading Tuesday. INCY has a 1-year high of $121.18 and a 1-year low of $55. The stock’s 50-day moving average is $105.05 and its 200-day moving average is $91.81.
On the ratings front, Incyte has been the subject of a number of recent research reports. In a report issued on January 10, BMO analyst Ian Somaiya reiterated a Buy rating on INCY, with a price target of $135, which implies an upside of 15% from current levels. Separately, on January 5, Jefferies Co.’s Brian Abrahams maintained a Buy rating on the stock and has a price target of $108.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ian Somaiya and Brian Abrahams have a yearly average return of 11.8% and 3.5% respectively. Somaiya has a success rate of 53% and is ranked #307 out of 4342 analysts, while Abrahams has a success rate of 47% and is ranked #1124.
Overall, 11 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 $115.75 which is -1.7% under where the stock opened today.
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.