Oncolytics Biotech Inc.’s ONCY lead pipeline candidate, Reolysin, has been granted orphan drug status by the FDA for yet another indication: the treatment of primary peritoneal cancers.
This is the fourth indication for which Reolysin has received orphan drug status in the U.S. Earlier this week, Reolysin was granted orphan drug status for the treatment of cancer of the fallopian tube. Last month, the company had gained orphan drug designation for Reolysin for the treatment of both ovarian and pancreatic cancer. Oncolytics is also seeking orphan drug status in the EU for ovarian and pancreatic cancer.
According to the company press release, about 16,250 patients in the U.S. suffer from primary peritoneal cancers at any given time.
The FDA usually grants orphan drug status to drugs or biologics that are being developed for the treatment of rare diseases/conditions affecting less than 200,000 people in the U.S. at any given time. This designation allows the product to enjoy a period of marketing exclusivity in the U.S., upon approval. Incentives that come with orphan drug status include tax credits as well as waiver of certain administrative fees.
We note that Oncolytics is also seeking orphan drug designation for Reolysin in the U.S. for high grade gliomas in pediatric patients. Meanwhile, Reolysin is being developed for the treatment of patients suffering from advanced or metastatic colorectal cancer. Being the lead candidate at Oncolytics, we expect investor focus to remain on further updates on Reolysin.
Oncolytics carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Cytokinetics Inc. CYTK, Theravance Inc. THRX and Cambrex Corp. CBM. All three are Zacks Rank #1 (Strong Buy) stocks.
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