Pharmacyclics, Inc. (PCYC) announced that the FDA is expected to render a final opinion on the supplemental New Drug Application (sNDA) for Imbruvica for patients with Waldenstrom's macroglobulinemia (WM) by Apr 17, 2015.
We note that the company had announced that it has submitted the sNDA to the FDA for Imbruvica in Oct 2014. Pharmacyclics filed the sNDA based on phase II study results. The FDA had granted Breakthrough Therapy designation to Imbruvica for this indication in Feb 2013.
As per the American Cancer Society, nearly 1,000 to 1,500 new cases of WM are reported each year with 12,000 people in the U.S. suffering from the disease. Once approved, the new treatment will provide significant benefit to the eligible patient population.
Imbruvica is currently approved for three indications including the treatment of patients with mantle cell lymphoma or chronic lymphocytic leukemia (CLL) who have received at least one previous therapy and for CLL patients (treatment naïve as well as experienced) with a deletion of the short arm of chromosome 17.
We note that Imbruvica is Pharmacyclics’ sole marketed product. The company has an agreement with Janssen Biotech, a Johnson & Johnson (JNJ) company, for Imbruvica. We are encouraged by Pharmacyclics’ efforts to expand Imbruvica’s label further.
Pharmacyclics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Allergan (AGN) and Actavis (ACT), both carrying a Zacks Rank #2 (Buy).
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