Investors in the pharma/biotech sector eagerly wait for pipeline updates as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight on the commercial potential of the candidate once it is successfully developed and commercialized.
Exelixis, Inc. EXEL announced that it has submitted its rolling New Drug Application (NDA) on cabozantinib with the FDA for the treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy.
A rolling submission will allow the company to complete portions of the application which needs to be submitted and reviewed by the FDA on an ongoing basis.
Additionally, Exelixis has requested the FDA for a priority review as part of the NDA filing.
We note that cabozantinib enjoys both Fast Track and Breakthrough Therapy designations for advanced RCC in the U.S, which should expedite its development process.
Meanwhile, Exelixis currently expects to complete its Marketing Authorization Application (MAA) in early 2016 for cabozantinib in Europe for RCC. We remind investors that the European Medicines Agency’s Committee for Medicinal Products for Human Use had recently granted accelerated assessment to cabozantinib for advanced RCC. Hence, the company’s MAA may be eligible for a 150-day review, versus the standard 210 days when the application is filed.
We note that cabozantinib is marketed in capsule form as Cometriq for the treatment of progressive, metastatic medullary thyroid cancer (MTC) in the U.S. and for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC in the EU. Exelixis is evaluating a tablet formulation of cabozantinib, distinct from the capsule form for advanced RCC.
Exelixis is also evaluating Cometriq across across multiple indications including advanced hepatocellular carcinoma among others.
We expect investor focus to remain on further updates on cabozantinib.
Exelixis carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Pfizer PFE, Bristol-Myers Squibb BMY, and Biodel Inc. BIOD. While Biodel sports a Zacks Rank #1 (Strong Buy), the other two carry a Zacks Rank #2 (Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment