Ignyta's Lead Drug Gets Orphan Status for Colorectal Cancer - Analyst Blog
Ignyta, Inc. (RXDX) announced that the FDA has granted orphan drug designation to its lead candidate entrectinib for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive or ALK-positive colorectal cancer.
We note that the FDA usually grants orphan drug status to novel candidates or biologics being developed as a potential treatment for rare diseases/conditions that affect less than 200,000 people in the U.S. This designation allows the product to enjoy seven years of marketing exclusivity in the U.S., upon approval.
Additionally, Ignyta is now eligible to receive tax credits for research and development costs, seek study design assistance from the FDA and apply for annual grant funding as well as request for the waiving of the Prescription Drug User Fee Act filing fee.
Earlier in the month, the candidate was granted orphan drug designation for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive and ALK-positive non-small cell lung cancer.
The candidate already enjoys orphan drug status for the treatment of neuroblastoma in the U.S. It was also granted rare pediatric designation for the same indication by the FDA.
The company has a license agreement with Nerviano Medical Sciences for the development and commercialization of entrectinib, which was modified in Dec 2014.
Meanwhile, Ignyta is also working on the development of its oncology pipeline, which includes RXDX-103 and RXDX-104.
We expect investor focus to remain on development updates on entrectinib, going forward, as it is the company's lead candidate.
Ignyta carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Lannett Inc. (LCI), Salix Pharmaceuticals (SLXP) and Sucampo Pharmaceuticals (SCMP). All three carry a Zacks Rank #1 (Strong Buy).
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