Kite Pharma, Inc.’s (KITE - Free Report) shares hit a new 52-week high of $143.00 on Thursday before eventually closing at $138.17.
Shares of the company have risen sharply so far this year as its CAR-T therapy axicabtagene ciloleucel (previously KTE-C19) is nearing an FDA approval. In fact, Kite Pharma’s year-to-date share price movement shows that the stock has substantially outperformed the industry, having skyrocketed 209.7% during the period, while the industry has gained 6.9%.
Kite Pharma has been riding on the back of an impressive progress made by axicabtagene ciloleucel. The candidate is currently under priority review in the United States for treating aggressive non-Hodgkin lymphoma (NHL) with an FDA decision expected on Nov 29. The Biologics License Application (BLA) filing was based on data from a phase I-II study, ZUMA-1.
We believe that the solid efficacy profile demonstrated by the pivotal ZUMA-1 trial should support the candidate’s approval this year. At the second-quarter conference call, the company announced that the FDA has informed that an Advisory Committee meeting will not be required to review the company’s BLA for axicabtagene ciloleucel. The candidate is expected to be approved of and launched in the United States this year.
In July, a regulatory application was also filed in the EU for the given indication with sanction and unveiling also expected next year.
Immuno-oncology is one of the most actively pursued areas of research today. There are several other companies working to bring about innovative immuno-oncology treatments to the market.
Juno Therapeutics Inc. (JUNO - Free Report) and Novartis AG (NVS - Free Report) are also developing JCAR017 and CTL019, respectively, utilizing the CAR-T cell technology. Though the efficacy profile of all the three candidates is comparable, axicabtagene ciloleucel is likely set to hit the market first.
Other studies revolving around axicabtagene ciloleucel are also advancing fast.
Apart from axicabtagene ciloleucel, Kite Pharma is developing additional CAR-based candidates including KITE-585 and KITE-718.
Phase I study on the first of the four TCR/CAR-T candidates — KITE-718 in solid tumors, including non-small cell lung cancer, bladder cancer plus head and neck cancer — was initiated in the second quarter. KITE-718, a TCR cell therapy candidate, targets cancer antigens MAGE A3 and MAGE A6 in a solid tumor.
Kite Pharma has also recently filed an investigational new drug (IND) application for CAR-T candidate, KITE-585, targeting BCMA antigen for multiple myeloma. Phase I studies are expected to be initiated in the second half of the year.
Zacks Rank & Stocks to Consider
Kite Pharma currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the pharma sector is ACADIA Pharmaceuticals Inc. (ACAD - Free Report) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
ACADIA’s loss per share estimates narrowed from $2.82 to $2.59 for 2017 and from $2.07 to $1.92 for 2018 over the last 30 days. The company came up with positive earnings surprises in two of the last four quarters with an average beat of 7.97%.
One Simple Trading Idea
Since 1988, the Zacks system has more than doubled the S&P 500 with an average gain of +25% per year. With compounding, rebalancing and exclusive of fees, it can turn thousands into millions of dollars.
This proven stock-picking system is grounded on a single big idea that can be fortune shaping and life changing. You can apply it to your portfolio starting today.
Learn more >>