Gilead's CAR-T Therapy Yescarta Gets Approval in Europe

Gilead Sciences, Inc . GILD announced that the European Commission (EC) has granted Marketing Authorization to its chimeric antigen receptor T cell (CAR-T) therapy, Yescarta.

Yescarta is approved in Europe as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.

CAR-T therapy harnesses a patient's own immune system to fight certain types of blood cancer.

The Marketing Authorization Application (MAA) is supported by data from the ZUMA-1 trial in adult patients with refractory aggressive NHL.

We remind investors that Yescarta was approved by the FDA in October 2017.

Yescarta generated sales of $68 million in the second quarter of 2018, up from $40 million in the previous quarter.

Label expansion of existing drugs bode well for Gilead. The initial uptake of Yescarta also looks encouraging, but it will take some time for its sales to boost the top line significantly due to the high cost of treatment. Moreover, Novartis' NVS Kymriah is also there in the market posing competition.

Recently, Kymriah won the EC approval for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) DLBCL, after two or more lines of systemic therapy, in Europe.

Gilead's stock has gained 6.8% in the year so far compared to the industry' s decline of 3.5%.

Concurrent with the second-quarter earnings, Gilead announced that its CEO, John F. Milligan will step down after serving the company for 28 years. The departure of the CEO at this crucial time further clouds the growth prospects of the company. Given the persistent decline in HCV sales, the company is looking to HIV and newer avenues to help its top line.

During the first quarter, Gilead announced an agreement with Sangamo Therapeutics, Inc. SGMO to use Sangamo's zinc finger nuclease technology platform for the development of next-generation ex vivo cell therapies in oncology. Gilead is also intending to foray into the NASH and inflammation market with late-stage candidates - selonsertib and filgotinib.

Gilead will have to generate substantial revenues from its HIV franchise and Yescarta to offset the HCV sales decline. This will be a challenging task for the company with stiff competition from the likes of GlaxoSmithKline GSK in the HIV market.

Zacks Rank

Gilead currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here.

Today's Stocks from Zacks' Hottest Strategies

It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.

And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.

See Them Free>>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Novartis AG (NVS): Free Stock Analysis Report

GlaxoSmithKline plc (GSK): Free Stock Analysis Report

Gilead Sciences, Inc. (GILD): Free Stock Analysis Report

Sangamo Therapeutics, Inc. (SGMO): Free Stock Analysis Report

To read this article on click here.

Zacks Investment Research

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

In This Story


Other Topics


Latest Markets Videos


Zacks is the leading investment research firm focusing on stock research, analysis and recommendations. In 1978, our founder discovered the power of earnings estimate revisions to enable profitable investment decisions. Today, that discovery is still the heart of the Zacks Rank. A wealth of resources for individual investors is available at

Learn More