Gilead Sciences, Inc.
GILD
has announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) adopted a positive opinion for Veklury (remdesivir).
Gilead is seeking the European Commission’s (“EC”) approval for the full marketing authorization (MA) of Veklury for treating COVID-19 patients.
Veklury has already been granted conditional marketing authorization (“CMA”) for adults and adolescents 12 years of age and older and weighing at least 40 kg, requiring supplemental oxygen.
The positive opinion of CHMP is supported by the fulfillment of the last specific obligation for Veklury, based on the review of virology data inclusive of in vitro data exhibiting that Veklury retains activity against variants of concern, including Alpha, Beta, Gamma, Delta and Omicron (BA.1 and BA.2).
Moreover, to support the change of CMA to MA, CHMP also reviewed the current risk-benefit of Veklury based on its safety and efficacy data accumulated since the CMA was granted in 2020.
Upon approval, Veklury will become the only direct-acting antiviral with full MA in the European Union.
Last year in December, theconditional authorization was expanded to include adults who do not require supplemental oxygen and are at increased risk of developing severe COVID-19.
Shares of Gilead have declined 14.2% year-to-date compared with the
industry
’s fall of 21.1%.
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Please note that Veklury is indicated for the treatment of COVID-19 in adults and pediatric patients.
Veklury’s sales have boosted Gilead’s sales in the last reported quarter and the same is likely to receive a boost from expanded indications.
Concurrently, Gilead’s wholly owned subsidiary, Kite, also received a positive recommendation from the CHMP for Tecartus (brexucabtagene autoleucel), to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia (“ALL”) in patients aged 26 years and above.
Upon approval, Tescartus will be the first and only Chimeric Antigen Receptor (CAR) T-cell therapy for the given indication.
The CHMP opinion is based on positive data from the phase I/II ZUMA-3 study.
A final decision from the European Commission is anticipated in the coming months.
Please note that Tecartus is already approved by the FDA under accelerated approval for the treatment of relapsed or refractory mantle cell lymphoma in adult patients. Additionally, last year, Tecartus also secured FDA approval to treat relapsed or refractory B-cell precursor ALL in patients above 18 years of age.
The approval of Tecartus will provide a good impetus to Gilead’s CAR T-cell therapy franchise, which is steadily gaining traction.
Zacks Rank and Stocks to Consider
Gilead currently carries a Zacks Rank #3 (Hold)
Some better-ranked stocks in the same sector include
Alkermes
ALKS
and
Seagen
SGEN
, each sporting a Zacks Rank #1 (Strong Buy) and
BioNTech
BNTX
, carrying a Zacks Rank #2 (Buy). You can see
the complete list of today’s Zacks #1 Rank stocks here
.
ALKS’ loss estimates for 2022 have narrowed to a cent from $0.00 to 4 cents in the past 30 days. The earnings estimate for 2023 increased from 56 cents to 59 cents in the same time frame.
Alkermes surpassed earnings in all the trailing four quarters, the average being 350.48%.
Seagen’s loss per share estimates for 2022 have narrowed from $3.50 to $3.49 in the past 30 days. The same for 2023 moved up from $1.41 cents to $1.43 cents in the same time frame. SGEN has returned 11% in the year-to-date period.
Earnings of Seagen missed estimates in two of the trailing four quarters and beat the same on the remaining two occasions, the average negative surprise being 40.08%.
BioNTech’s earnings per share estimates for 2022 have narrowed from $34.82 to $33.51 in the past 30 days. The same for 2023 has increased from $15.60 to $16.27 in the same time frame.
Earnings of BioNTech beat estimates in all the trailing four quarters, the average surprise being 56.87%.
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