Gilead's Mantle Cell Lymphoma Drug MAA Gets EMA Validation

Gilead Sciences Inc.’s (NASDAQ:GILD) company, Kite, announced that its Marketing Authorization Application (MAA) for KTE-X19 has been fully validated.Itis now under evaluation with the European Medicines Agency (EMA). KTE-X19 is an investigational chimeric antigen receptor (CAR) T cell therapy being developed for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). MCL is a rare form of non-Hodgkin lymphoma (NHL) that arises from cells originating in the "mantle zone" of the lymph node.

The MAA is supported by data from the single-arm, open-label, phase II ZUMA-2 study, which demonstrated an overall response rate of 93%, including 67% with complete response, as assessed by an Independent Radiologic Review Committee (IRRC) following a single infusion of KTE-X19 (median follow-up of 12.3 months).

Shares of the company have decreased 7.5% in the past year compared with the industry’s decline of 5.6%.

Kite submitted a biologics license application (BLA) for KTE-X19 to the FDA on Dec 11, 2019, for the treatment of adult patients with relapsed or refractory MCL. The candidate has been granted Breakthrough Therapy Designation (BTD) by the FDA and Priority Medicines (PRIME) by the EMA.

Apart from MCL, KTE-X19 is currently in phase I/II studies in acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL).

Gilead has a robust pipeline, with several development programs currently underway, ranging from phase I through phase III.

Zacks Rank & Stocks to Consider

Gilead is currently a Zacks Rank #3 (Hold) stock.

A few better-ranked stocks in the biotech sector are BioDelivery Sciences International Inc. (NASDAQ:BDSI) , Guardant Health Inc. (NASDAQ:GH) and Denali Therapeutics Inc. (NASDAQ:DNLI) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

BioDelivery’s loss per share estimates have narrowed from 21 cents to 16 cents for 2019 in the past 90 days. The company delivered a positive earnings surprise in the trailing four quarters by 159.38%, on average.

Guardant’s loss per share estimates have narrowed from $1.27 to 88 cents for 2019 and from $1.29 to $1.18 for 2020 in the past 90 days. The company delivered a positive earnings surprise in the trailing four quarters by 39.21%, on average.

Denali’s loss per share estimates have narrowed from $2.04 to $2.02 for 2019 and from $2.40 to $2.39 for 2020 in the past 90 days.

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