Gilead Sciences (NASDAQ:GILD), Inc.’s GILD subsidiary, Kite, announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA for Yescarta (axicabtagene ciloleucel) for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma after two or more prior lines of systemic therapy. Follicular lymphoma and marginal zone lymphoma are both forms of indolent non-Hodgkin lymphoma (NHL) in which malignant tumors slowly grow but can become more aggressive over time.
Yescarta was previously granted Breakthrough Therapy Designation by the FDA for these indications. The submission was supported by data from the ZUMA-5 study.
Shares of Gilead have increased 1.6% year to date against the industry’s decline of 2.3%.
ZUMA-5, is a global, multicenter, single-arm, open-label phase II study evaluating Yescarta in adults with relapsed or refractory indolent (slow growing) non-Hodgkin lymphoma (NHL) after at least two prior lines of therapy. An interim analysis of the study presented in June 2020 showed that 93% of patients (n=96 evaluable for efficacy) responded, with 80% achieving a complete response as assessed by an independent review committee after a single infusion of Yescarta.
If approved, Yescarta would become the first chimeric antigen receptor (CAR) T cell therapy approved for the treatment of relapsed or refractory indolent NHL.
Yescarta was the first CAR T cell therapy to be approved by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, and high-grade B-cell lymphoma and DLBCL arising from FL.
Label expansion of the drug will boost sales for the company.
Zacks Rank & Other Stocks to Consider
Gilead currently carries a Zacks Rank #3 (Hold).
Some other better-ranked stocks in the healthcare sector include Emergent Biosolutions (NYSE:EBS) Inc. EBS, Bio Techne Corp TECH and Alimera (NASDAQ:ALIM) Sciences Inc. ALIM. While Emergent and Bio Techne sport a Zacks Rank #1, Alimera carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings estimates have increased from $3.45 to $6.32 for 2020 and from $4.31 to $7.01 for 2021 over the past 60 days. Shares of the company have increased 94.2% year to date.
Bio Techne’s earnings estimates have increased from $5.33 to $5.58 for 2020 and from $6.41 to $6.45 for 2021 over the past 60 days. Shares of the company have increased 12.1% year to date.
Alimera’s loss per share estimates have narrowed from $2.33 to $1.31 for 2020 and from 63 cents to 52 cents for 2021 over the past 60 days. Shares of the company have decreased 24.1% year to date.
The Hottest Tech Mega-Trend of All
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>
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
Gilead Sciences, Inc. (GILD): Free Stock Analysis Report
Emergent Biosolutions Inc. (EBS): Free Stock Analysis Report
Alimera Sciences, Inc. (ALIM): Free Stock Analysis Report
BioTechne Corp (TECH): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research