Kite Pharma Inc (NASDAQ:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted positive opinions recommending KTE-C19 for designation as an orphan medicinal product for the treatment of ALL, CLL/SLL, and FL. KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a chimeric antigen receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. Kite previously received orphan drug designation for KTE‑C19 for the treatment of diffuse large B‑cell lymphoma (DLBCL) in both the US and the EU, as well as COMP positive opinions for orphan drug designation in the EU for primary mediastinal B-cell lymphoma (PMBCL) and mantle cell lymphoma (MCL).
“The orphan drug designation is an important regulatory milestone as we further our development of KTE-C19 in advanced hematological cancers, where there are limited treatment options,” said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer. “We are excited by the progress of our ongoing Phase 1/2 clinical trial (ZUMA-1) of KTE-C19 in patients with refractory, aggressive non-Hodgkin lymphoma, including DLBCL, PMBCL and transformed follicular lymphoma (TFL), for which we anticipate presenting top-line Phase 1 data later this year.”
The COMP adopts an opinion on the granting of orphan drug designation, after which the opinion is submitted to the European Commission (EC) for endorsement of the opinion. Orphan drug designation by the EC provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the EU, and where no satisfactory treatment is available. In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan drug designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure. (Original Source)
Shares of Kite Pharma Inc closed yesterday at $60.40. KITE has a 1-year high of $89.21 and a 1-year low of $28.55. The stock’s 50-day moving average is $59.07 and its 200-day moving average is $60.10.
On the ratings front, Kite Pharma has been the subject of a number of recent research reports. In a report issued on September 24, Maxim Group analyst Jason McCarthy reiterated a Buy rating on KITE, with a price target of $87, which implies an upside of 44.0% from current levels. Separately, on the same day, Stifel Nicolaus’ Thomas Shrader reiterated a Buy rating on the stock and has a price target of $84.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason McCarthy and Thomas Shrader have a total average return of -10.9% and -12.7% respectively. McCarthy has a success rate of 31.0% and is ranked #3547 out of 3773 analysts, while Shrader has a success rate of 22.2% and is ranked #3522.
Kite Pharma Inc is a clinical-stage bio pharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to eradicate cancer cells.