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FOSTER CITY, Calif. - Gilead Sciences, Inc. (NASDAQ:GILD), a prominent biotechnology company with a market capitalization of $129.7 billion and impressive 78% gross profit margins, has announced the FDA’s acceptance of its New Drug Application (NDA) for lenacapavir, a twice-yearly injectable drug designed for the prevention of HIV. The FDA will conduct a priority review with a target action date of June 19, 2025. According to InvestingPro analysis, Gilead maintains a strong financial health score, positioning it well for this expansion.
Lenacapavir received the FDA’s Breakthrough Therapy Designation in October 2024, a status that expedites the development and review process for promising treatments for serious conditions. The NDA submissions are based on results from Phase 3 trials, which demonstrated a significant reduction in HIV infections with lenacapavir compared to oral Truvada® and no significant safety concerns.
Dietmar Berger, MD, PhD, Chief Medical (TASE:PMCN) Officer at Gilead Sciences, expressed optimism about lenacapavir’s potential impact on HIV prevention, noting that approval could transform the preventive landscape for individuals seeking alternative options.
The drug has shown promise in clinical trials, with PURPOSE 1 reporting zero infections in the lenacapavir group and a 100% risk reduction in cisgender women. PURPOSE 2 showed a 96% risk reduction among a diverse group of cisgender men and gender-diverse individuals. This development has contributed to Gilead’s strong market performance, with InvestingPro data showing a 51% return over the past year and the stock currently trading near its 52-week high of $106.69.
Gilead’s strategy aims to expedite regulatory review and access to lenacapavir for PrEP globally. The company has submitted applications to the European Medicines Agency (EMA) for an accelerated assessment and aims to facilitate access in low- and lower-middle-income countries through the EU-Medicines for All (EU-M4all) application.
The drug is currently approved in multiple countries for the treatment of multi-drug resistant HIV in adults, in combination with other antiretrovirals. Its use for HIV prevention remains investigational, and the FDA has not yet established its safety and efficacy for this purpose.
The information in this article is based on a press release statement. The use of lenacapavir for HIV prevention is not approved anywhere globally, and there is no cure for HIV or AIDS. Gilead continues to innovate in HIV treatment and prevention, with a focus on long-acting therapeutic options and a commitment to ending the HIV epidemic globally. With revenue growth of 6% in the last twelve months and strong cash flows, the company appears well-positioned to support its innovation pipeline. For detailed analysis and 15+ additional ProTips about Gilead’s financial outlook, visit InvestingPro, where you can access comprehensive Pro Research Reports covering what really matters about this leading biotech stock.
In other recent news, Gilead Sciences has been in the spotlight with several financial institutions adjusting their price targets for the company. TD Cowen raised its price target to $100, following Gilead’s fourth-quarter earnings announcement, which showcased a strong performance in both revenue and earnings, driven by its HIV and liver disease segments, and the cancer drug Trodelvy. RBC Capital also increased its price target for Gilead to $90, highlighting the company’s potential growth drivers post-2025.
BMO Capital showed confidence in Gilead’s prospects for 2025, particularly with the anticipated launch of the long-acting PrEP medication, raising its price target to $115. Piper Sandler, too, increased its price target for Gilead to $110, citing the company’s robust fiscal year 2024 performance and encouraging guidance for fiscal year 2025. Finally, Oppenheimer maintained its Outperform rating and $115 price target for Gilead, following a strong fourth-quarter performance that surpassed consensus estimates.
These recent developments reflect a broader market sentiment that Gilead Sciences is well-positioned to sustain its growth trajectory and continue its leadership in the BioPharma sector. The company’s strategic initiatives, robust financial performance, and upcoming product launches are key factors contributing to these positive assessments.
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