FOSTER CITY, Calif. - Gilead Sciences, Inc. (NASDAQ:GILD) has received accelerated approval from the U.S. Food and Drug Administration (FDA) for its new drug Livdelzi (seladelpar), indicated for the treatment of primary biliary cholangitis (PBC). The approval, announced today, is specifically for use in adults with an inadequate response to ursodeoxycholic acid (UDCA), or for those who cannot tolerate UDCA.
Livdelzi's approval is based on the Phase 3 RESPONSE study, which showed that 62% of participants achieved the primary endpoint of composite biochemical response at 12 months when treated with Livdelzi, compared to 20% with placebo.
Additionally, 25% of patients on Livdelzi achieved normalization of alkaline phosphatase (ALP) levels at 12 months, a key marker of disease progression in PBC. Notably, patients treated with Livdelzi also experienced a statistically significant reduction in pruritus, a common and distressing symptom of PBC, at 6 months.
While the accelerated approval is based on ALP reduction, the FDA has not yet confirmed improvements in survival or prevention of liver decompensation events with Livdelzi. Continued approval may depend on the verification of clinical benefits in ongoing confirmatory trials, such as the Phase 3 AFFIRM study.
Daniel O'Day, Chairman and CEO of Gilead Sciences, emphasized the importance of providing a new treatment option to patients with PBC, underscoring Gilead's commitment to liver disease.
Gilead's Support Path® Program is set to offer assistance to patients prescribed Livdelzi, ensuring they understand their coverage and financial options. The company also plans to sustain funding for PBC patient organizations following its acquisition of CymaBay.
In other recent news, Gilead Sciences Inc . reported noteworthy growth in its second quarter of 2024 earnings call. The pharmaceutical company noted a 6% year-over-year rise in total product sales, reaching $6.7 billion. This growth was driven by an 8% increase in sales for its HIV treatment Biktarvy and a 23% rise in sales for the oncology drug Trodelvy. In response to these successful results, Gilead has raised its full-year non-GAAP operating income and EPS guidance.
Among other recent developments, Gilead reported 100% efficacy in a Phase 3 trial of lenacapavir for HIV prevention, and plans to file for regulatory approval based on the data from these trials. The company also noted a 17% year-over-year increase in its Liver Disease portfolio sales, with the upcoming launch of seladelpar in the US. However, despite overall growth, certain products like Descovy and Veklury experienced a decline in sales.
In the face of these developments, Gilead remains on track to achieve its key milestones for 2024, with strong execution expected in the latter half of the year. The company is also preparing for the launch of seladelpar for PBC in the US and anticipates a European regulatory decision in early 2025.
InvestingPro Insights
As Gilead Sciences, Inc. (NASDAQ:GILD) celebrates the FDA's accelerated approval of its new drug Livdelzi for primary biliary cholangitis (PBC), investors may be examining the company's financial health and market performance. Gilead's commitment to innovation in liver disease treatment is reflected not only in its product pipeline but also in its strong financial metrics and investor returns.
According to recent data from InvestingPro, Gilead boasts a market capitalization of $92.22 billion, underscoring its significant presence in the biotechnology industry. The company's dedication to shareholder returns is evident through its high shareholder yield and a history of raising its dividend for 9 consecutive years, a testament to its stable financial footing and commitment to returning value to investors. In fact, Gilead's dividend yield stands at an attractive 4.16%, as of the last recorded date, which is particularly compelling for income-focused investors.
One InvestingPro Tip for Gilead is the company's strong free cash flow yield, which suggests that the company is generating ample cash to support its operations and investment opportunities. This financial flexibility is crucial as the company navigates the competitive landscape of biotechnology and continues to invest in research and development for groundbreaking treatments like Livdelzi.
Additionally, Gilead's stock is known to trade with low price volatility, providing a level of stability in an often turbulent market sector. This could be an attractive feature for investors who are cautious about the inherent risks in the biotech industry.
For those interested in a deeper dive into the company's financials and future prospects, InvestingPro offers a comprehensive suite of metrics and additional InvestingPro Tips. There are currently 17 additional tips available for Gilead Sciences, which can be accessed at https://www.investing.com/pro/GILD, providing investors with a more nuanced understanding of the company's performance and potential investment opportunities.
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