Updates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of investigational new drug applications and marketing applications, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and, finally, a response from the regulatory agency regarding the approval status.
Early last week, Kite Pharma, Inc. (KITE) provided a regulatory update on its lead candidate, KTE-C19. The company announced the submission of an investigational new drug application (IND) to the FDA for KTE-C19.
Kite Pharma intends to conduct a single-arm multi-center phase I/II study on KTE-C19 for the treatment of patients with refractory aggressive non-Hodgkin lymphoma (NHL). In 2015, the company plans to initiate a phase I/II study on KTE-C19 for refractory diffuse large B cell lymphoma (DLBCL) including primary mediastinal B-cell lymphoma and transformed follicular lymphoma.
Kite Pharma also has plans to conduct additional studies on KTE-C19 for other types of B-cell lymphoma and leukemia.
According to the National Cancer Institute, in 2014, 70,800 new patients have been diagnosed with NHL in the U.S. with 18,990 patients dying from the disease.
We note that KTE-C19 enjoys orphan drug status in the U.S. for the treatment of DLBCL. Additionally, the company intends to seek Breakthrough Therapy designation for the candidate for the treatment of aggressive NHL and some other types of cancer. Last month, KTE-C19 received a positive opinion from the European Medicines Agency’s Committee for Orphan Medicinal Products for orphan medicinal product designation for the treatment of DLBCL. The opinion has been submitted to the European Commission for endorsement.
Since KTE-C19 leads Kite Pharma’s pipeline, we expect investor focus to remain on its development updates.
Kite Pharma carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the biotech sector are Amgen Inc. (AMGN), The Medicines Company (MDCO) and Cytokinetics, Inc. (CYTK). All these stocks carry a Zacks Rank #1 (Strong Buy).
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