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Gilead (GILD) Outpaces Industry in Six Months: What Lies Ahead?
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Shares of Gilead Sciences, Inc. (GILD - Free Report) have gained 3.7% in the last six months against the industry’s decline of 10.3%.
The going has been good for Gilead Sciences of late, with a string of positive news.
Gilead’s HIV treatment lenacapavir has been approved by the European Commission (“EC”) 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 is otherwise not possible to construct a suppressive anti-viral regimen.
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. This is a big advantage over the existing treatments and will enable Gilead to capture market share.
Image Source: Zacks Investment Research
The approval will strengthen Gilead’s strong HIV portfolio, which maintains momentum on the back of growth in demand for flagship HIV therapy Biktarvy. 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. The approval of new treatments will also offset the decline in revenues due to the loss of exclusivity of Truvada.
Earlier this month, Gilead announced statistically significant and clinically meaningful results from the second interim analysis of the key secondary endpoint of overall survival (OS) in phase III TROPiCS-02 study evaluating Trodelvy in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. This impressed the investors.
Gilead has submitted a supplemental biologics license application (sBLA) to the FDA for the same. A potential label expansion in this lucrative field will help Gilead gain a foothold in the oncology space as it looks to diversify its portfolio.
Trodelvy’s sales increased 79% to $159 million in the second quarter, reflecting uptake in both the second and third-line settings for the treatment of metastatic triple-negative breast cancer (TNBC) in the United States and Europe as well as for metastatic urothelial cancer in the United States.
Gilead also announced an agreement with Everest Medicines to acquire the remaining worldwide rights to Trodelvy.
Gilead also reported strong second-quarter results driven by continued solid demand for Biktarvy, and oncology revenues driven by cell therapy and Trodelvy. Sales of COVID-19 treatment, Veklury (remdesivir), declined as predicted but came in better than expected. Management upped its revenue guidance.
While Veklury significantly boosted revenues last year, the decline in sales due to rising immunity against the virus has caused uncertainty around the sales.
Consequently, Gilead is more focused on its HIV franchise and is also looking to strengthen its oncology portfolio.
However, 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.
Moreover, the oncology space is lucrative but saturated as well.
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 surpassed estimates in two of the trailing four quarters.
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Gilead (GILD) Outpaces Industry in Six Months: What Lies Ahead?
Shares of Gilead Sciences, Inc. (GILD - Free Report) have gained 3.7% in the last six months against the industry’s decline of 10.3%.
The going has been good for Gilead Sciences of late, with a string of positive news.
Gilead’s HIV treatment lenacapavir has been approved by the European Commission (“EC”) 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 is otherwise not possible to construct a suppressive anti-viral regimen.
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. This is a big advantage over the existing treatments and will enable Gilead to capture market share.
Image Source: Zacks Investment Research
The approval will strengthen Gilead’s strong HIV portfolio, which maintains momentum on the back of growth in demand for flagship HIV therapy Biktarvy. 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. The approval of new treatments will also offset the decline in revenues due to the loss of exclusivity of Truvada.
Earlier this month, Gilead announced statistically significant and clinically meaningful results from the second interim analysis of the key secondary endpoint of overall survival (OS) in phase III TROPiCS-02 study evaluating Trodelvy in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. This impressed the investors.
Gilead has submitted a supplemental biologics license application (sBLA) to the FDA for the same. A potential label expansion in this lucrative field will help Gilead gain a foothold in the oncology space as it looks to diversify its portfolio.
Trodelvy’s sales increased 79% to $159 million in the second quarter, reflecting uptake in both the second and third-line settings for the treatment of metastatic triple-negative breast cancer (TNBC) in the United States and Europe as well as for metastatic urothelial cancer in the United States.
Gilead also announced an agreement with Everest Medicines to acquire the remaining worldwide rights to Trodelvy.
Gilead also reported strong second-quarter results driven by continued solid demand for Biktarvy, and oncology revenues driven by cell therapy and Trodelvy. Sales of COVID-19 treatment, Veklury (remdesivir), declined as predicted but came in better than expected. Management upped its revenue guidance.
While Veklury significantly boosted revenues last year, the decline in sales due to rising immunity against the virus has caused uncertainty around the sales.
Consequently, Gilead is more focused on its HIV franchise and is also looking to strengthen its oncology portfolio.
However, 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.
Moreover, the oncology space is lucrative but saturated as well.
Zacks Rank and Stocks to Consider
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 surpassed estimates in two of the trailing four quarters.