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Gilead (GILD) Gets EC Approval for Biktarvy Label Expansion

Gilead Sciences, Inc. GILD announced that the European Commission (EC) has authorized a new low-dose tablet version of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets).

The EC also expanded Biktarvy’s label for the treatment of HIV infection in virologically suppressed children who are at least two years of age and weigh at least 14 kg. The European Marketing Authorization is the first pediatric approval for Biktarvy in the European Union (EU) and applies to all 27 member states of the EU, as well as Norway, Iceland and Liechtenstein.

This authorization and label expansion were based on an open-label study (NCT02881320), which found Biktarvy to be effective and generally well-tolerated through 24 weeks in virologically suppressed adolescents and children with HIV.

We remind investors that Biktarvy is already approved in the EU for the treatment of HIV infection in adults. Biktarvy is Gilead’s flagship HIV therapy.

Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering a simple once-daily dosing regimen. Biktarvy combines the novel, unboosted INSTI bictegravir with the Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone.

Shares have gained 18.1% in the year so far against the industry’s decline of 19.9%.

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Biktarvy remains the leading medicine for those seeking to switch to a new regimen in the United States as well as those starting treatments in both the United States and Europe and it maintains momentum for Gilead.

Gilead has a strong HIV portfolio with Biktarvy and Descovy. The HIV franchise recently got a boost due to the European Commission’s approval of the HIV treatment lenacapavir under the brand name Sunlenca for treating HIV infection, in combination with other antiretroviral(s), in adults with multi-drug-resistant HIV infection, for whom it’s otherwise impossible to construct a suppressive anti-viral regimen. Sunlenca is the only HIV treatment option administered twice a year, acting as a big advantage over the existing treatments and should enable Gilead to capture market share.

Concurrently, Gilead is making efforts to develop its oncology business to diversify its revenue base as competition in the HIV business is stiff from the likes of GSK plc GSK and Johnson & Johnson’s Jannsen. Hence, the approval of new treatments holds the key.

GSK’s HIV franchise recorded 7% growth in the third quarter. Growth was driven by new HIV products — Dovato, Cabenuva, Rukobia, Juluca and Apretude — and a favorable U.S. pricing mix.

Gilead currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the healthcare sector include Biogen BIIB and Solid Biosciences SLDB, which carry the same rank as Gilead. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 30 days, earnings estimates for Biogen have increased by 30 cents to $16.98. Biogen also surpassed estimates in three of the trailing four quarters, with the average being 7.02%.

Over the past 30 days, loss estimates for Solid Biosciences have narrowed to $8.04 from $10.15. SLDB missed estimates in three of the trailing four quarters, with the average negative surprise being 4.15%.

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