Exelixis, Inc. (EXELׁ) Receives FDA Orphan Drug Designation for the Treatment of Hepatocellular Carcinoma


Exelixis, Inc. (NASDAQ:EXEL) announced that the FDA has granted orphan drug designation to cabozantinib for the treatment of hepatocellular carcinoma (HCC). This information was posted to FDA’s website on March 4, 2017 and can be accessed here. A pivotal phase 3 trial (CELESTIAL) of cabozantinib is ongoing in patients with advanced HCC, and Exelixis has guided that data from the trial are expected in 2017.

Orphan drug status is granted to treatments for diseases that affect fewer than 200,000 people in the U.S. and provides certain incentives for medications intended for the treatment, diagnosis or prevention of rare diseases. At present, these incentives include seven years of marketing exclusivity for the orphan indication, certain federal grants, tax credits and waiver of certain FDA fees.

Shares of Exelixis are up nearly 2% to $23.50 in pre-market trading. EXEL has a 1-year high of $23.49 and a 1-year low of $3.55. The stock’s 50-day moving average is $20.51 and its 200-day moving average is $15.63.

On the ratings front, Exelixis has been the subject of a number of recent research reports. In a report issued on February 28, William Blair analyst John Sonnier reiterated a Buy rating on EXEL. Separately, on the same day, Stifel Nicolaus’ Stephen Willey downgraded the stock to Hold and has a price target of $22.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, John Sonnier and Stephen Willey have a yearly average return of 18.2% and 20.1% respectively. Sonnier has a success rate of 54% and is ranked #383 out of 4513 analysts, while Willey has a success rate of 54% and is ranked #207.

Overall, one research analyst has assigned a Hold rating and 3 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 $21.00 which is -9.0% under where the stock closed last Friday.

Exelixis, Inc. is a biopharmaceutical company, which engages in the developing and commercializing small molecule therapies for the treatment of cancer. Its brands include COMETRIQ and cobimetinib. The company focuses on their proprietary resources and development and commercialization of cabozantinib.

 

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