Kite Pharma Inc (KITE) Announces Submission of Biologics License Application to FDA for Axicabtagene Ciloleucel


Kite Pharma Inc (NASDAQ:KITE) announced that it has completed the rolling submission with theU.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) for axicabtagene ciloleucel (previously known as KTE-C19) as a treatment for patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT).

“Last month, we announced positive results from our ZUMA-1 pivotal trial with axicabtagene ciloleucel,” said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. “We look forward to working closely with the FDA during the review of axicabtagene ciloleucel and the possibility of bringing this therapy to patients with aggressive NHL whose outlook is dismal with current therapy.”

In December 2015 axicabtagene ciloleucel received Breakthrough Therapy Designation (BTD) by the FDA for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL). If approved, Kite plans to commercially launch axicabtagene ciloleucel in 2017. Kite is also planning a regulatory submission to the European Medicines Agency (EMA) for axicabtagene ciloleucel in 2017.

“The Leukemia & Lymphoma Society (LLS) applauds Kite for achieving this significant milestone and bringing this promising therapy closer to patients with lymphoma who desperately need new options,” said Louis J. DeGennaro, Ph.D., LLS President and Chief Executive Officer. “LLS has supported companies that are working to dramatically change cancer treatment through the development of immunotherapy for the past two decades, and we immediately recognized the great opportunity to support Kite’s CAR-T program in 2015 through our Therapy Acceleration Program ® (TAP). Partnerships created through TAP, now in its tenth year, have the potential to bring several breakthrough therapies, such as axicabtagene ciloleucel, to patients in the coming year.”

The ZUMA-1 pivotal trial for axicabtagene ciloleucel for the treatment of patients with aggressive NHL was supported in part by funding from LLS’ TAP.

Shares of Kite Pharma closed today at $78.49, up $0.22 or 0.28%. KITE has a 1-year high of $88.58 and a 1-year low of $39.82. The stock’s 50-day moving average is $70.35 and its 200-day moving average is $55.29.

On the ratings front, KITE has been the subject of a number of recent research reports. In a report issued on March 27, BTIG analyst Dane Leone reiterated a Hold rating on KITE. Separately, on March 20, Roth Capital’s Mark Breidenbach reiterated a Buy rating on the stock and has a price target of $93.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Dane Leone and Mark Breidenbach have a yearly average return of 13.4% and a loss of -6.9% respectively. Leone has a success rate of 72% and is ranked #215 out of 4558 analysts, while Breidenbach has a success rate of 42% and is ranked #4196.

Overall, 6 research analysts have assigned a Hold rating and 9 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $80.40, which is 3.0% above where the stock opened today.

Kite Pharma, Inc. is a clinical stage biotechnology company, which engages in the development and commercialization of novel cancer immunotherapy products designed to target and kill cancer cells. It uses engineered autologous cell therapy, which involves the genetic engineering of T cells. Its lead product candidate, KTE-C19, a CAR-based therapy, which seeks treat patients with refractory diffuse large B-cell lymphoma, primary mediastinal large B-Cell lymphoma, and transformed follicular lymphoma.

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