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Gilead (GILD) Twice-Yearly HIV Treatment Gets EC Approval
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Gilead Sciences, Inc. (GILD - Free Report) recently announced that its HIV treatment Sunlenca (lenacapavir) has been approved by the European Commission (“EC”).
The EC has granted marketing authorization to Sunlenca injection and tablets for treating HIV infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.
The phase II/III CAPELLA study evaluated lenacapavir in combination with an optimized background regimen in people with multi-drug resistant HIV who are heavily treatment-experienced. Of the participants, 83% receiving lenacapavir in addition to an optimized background regimen achieved an undetectable viral load (<50 copies/mL) at week 52.
Per the company, most anti-virals act on just one stage of viral replication while Sunlenca is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross-resistance to other existing drug classes. In addition, Sunlenca is the only HIV treatment option administered twice yearly.
The approval will strengthen Gilead’s strong HIV portfolio.
Last month, the FDA also accepted the company’s new drug application (NDA) resubmission for lenacapavir. The agency has assigned a target action date of Dec 27, 2022. Additional regulatory filings and decisions by regulatory authorities are anticipated later in 2022.
The stock has lost 10.7% so far in the year compared with the industry's decline of 20.8%.
Image Source: Zacks Investment Research
Gilead’s HIV portfolio continues to maintain momentum for the company, driven by growth in demand for flagship HIV therapy Biktarvy. Descovy (FTC 200mg/TAF 25mg) sales have also boosted the top line. However, the loss of exclusivity for Truvada has hurt the company’s business.
Competition is stiff in the HIV business from the likes of GSK plc (GSK - Free Report) .
GSK’s HIV franchise recorded 7% growth in the second quarter. Growth was driven by new HIV products Dovato, Cabenuva, Rukobia, Juluca and Apretude and a favorable U.S. pricing mix.
Loss estimates for BOLT have narrowed to $2.54 from $2.87 in the past 60 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of Dynavax have surpassed estimates in two of the trailing four quarters.
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Gilead (GILD) Twice-Yearly HIV Treatment Gets EC Approval
Gilead Sciences, Inc. (GILD - Free Report) recently announced that its HIV treatment Sunlenca (lenacapavir) has been approved by the European Commission (“EC”).
The EC has granted marketing authorization to Sunlenca injection and tablets for treating HIV infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.
The phase II/III CAPELLA study evaluated lenacapavir in combination with an optimized background regimen in people with multi-drug resistant HIV who are heavily treatment-experienced. Of the participants, 83% receiving lenacapavir in addition to an optimized background regimen achieved an undetectable viral load (<50 copies/mL) at week 52.
Per the company, most anti-virals act on just one stage of viral replication while Sunlenca is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross-resistance to other existing drug classes. In addition, Sunlenca is the only HIV treatment option administered twice yearly.
The approval will strengthen Gilead’s strong HIV portfolio.
Last month, the FDA also accepted the company’s new drug application (NDA) resubmission for lenacapavir. The agency has assigned a target action date of Dec 27, 2022. Additional regulatory filings and decisions by regulatory authorities are anticipated later in 2022.
The stock has lost 10.7% so far in the year compared with the industry's decline of 20.8%.
Image Source: Zacks Investment Research
Gilead’s HIV portfolio continues to maintain momentum for the company, driven by growth in demand for flagship HIV therapy Biktarvy. Descovy (FTC 200mg/TAF 25mg) sales have also boosted the top line. However, the loss of exclusivity for Truvada has hurt the company’s business.
Competition is stiff in the HIV business from the likes of GSK plc (GSK - Free Report) .
GSK’s HIV franchise recorded 7% growth in the second 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 #3 (Hold). A couple of better-ranked stocks in the sector are Bolt Pharmaceuticals (BOLT - Free Report) and Dynavax (DVAX - Free Report) . Both carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for BOLT have narrowed to $2.54 from $2.87 in the past 60 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of Dynavax have surpassed estimates in two of the trailing four quarters.