FOSTER CITY, Calif. - Gilead Sciences, Inc. (NASDAQ:GILD) today shared interim results from an ongoing Phase 3 ASSURE study, demonstrating that 81% of primary biliary cholangitis (PBC) patients treated with Livdelzi achieved a composite biochemical response. The data, presented at The Liver Meeting 2024, also indicated that 41% of participants reached normal alkaline phosphatase (ALP) levels, a key liver function marker.
The ASSURE study evaluates the long-term efficacy and safety of Livdelzi in adults with PBC who have not responded adequately or are intolerant to ursodeoxycholic acid (UDCA). As of January 31, 2024, the analysis included all participants in the ASSURE study, with no serious adverse events linked to the treatment reported, and a decreasing incidence of adverse events over time.
Dr. Eric J. Lawitz, the study's principal investigator, noted the importance of ALP normalization in PBC management and the potential of Livdelzi as a promising treatment option for patients.
Gilead also presented findings from the RESPONSE trial, which highlighted Livdelzi's efficacy and safety in PBC patients with compensated cirrhosis and its impact on pruritus severity. The RESPONSE trial is a pivotal Phase 3, double-blind, placebo-controlled clinical trial assessing Livdelzi's efficacy and safety.
Livdelzi is an oral PPAR-delta agonist and the first treatment to show statistically significant and durable improvements in both pruritus and markers of cholestasis related to the risk of disease progression. The drug received accelerated approval from the U.S. Food and Drug Administration (FDA) in August 2024 for treating PBC in combination with UDCA or as monotherapy for patients who cannot tolerate UDCA.
The company also shared safety data from a comprehensive analysis across the Livdelzi program, emphasizing the drug's tolerability with up to five years of use.
Gilead remains committed to advancing therapies for challenging liver diseases, with Livdelzi being part of their effort to address the unmet needs of PBC patients. The information presented is based on a press release statement from Gilead Sciences, Inc.
In other recent news, Gilead Sciences received a Buy rating from Citi, which set a price target of $125. This positive outlook is based on the expected growth of Gilead's HIV treatment, Biktarvy, and the potential of its upcoming drug, lenacapavir. Citi's analysis suggests a strong long-term outlook for Gilead, predicting a 5-year revenue and non-GAAP earnings per share (EPS) compound annual growth rate (CAGR) from 2024 to 2029 of 3% and 18%, respectively.
In addition, Gilead announced its earnings results for the third quarter of 2024. The earnings call, led by Chairman and CEO Daniel O'Day, did not detail any misses in earnings or expectations but did include forward-looking statements about Gilead's future performance. The specifics of these expectations, however, were not disclosed.
Citi also forecasts meaningful operating margin expansion for Gilead, surpassing consensus expectations of 45%, attributed to the company's ongoing efficiency improvements. The cell therapy franchise is expected to increase its revenue contribution to 8% by 2026. These recent developments highlight Gilead's potential for growth and profitability, based on both current operations and future expectations as stated by Citi.
InvestingPro Insights
Gilead Sciences' recent presentation of promising results for Livdelzi in treating primary biliary cholangitis (PBC) aligns with the company's strong market position and financial performance. According to InvestingPro data, Gilead boasts a substantial market capitalization of $111.37 billion, reflecting investor confidence in its pipeline and existing product portfolio.
The company's revenue growth of 7.02% in the most recent quarter, coupled with a robust gross profit margin of 77.8%, underscores its ability to effectively commercialize treatments like Livdelzi. This financial strength supports Gilead's ongoing research and development efforts in liver diseases and other therapeutic areas.
InvestingPro Tips highlight Gilead's stability and growth potential. The company has raised its dividend for 10 consecutive years, demonstrating a commitment to shareholder returns. Additionally, 15 analysts have revised their earnings upwards for the upcoming period, suggesting positive expectations for Gilead's financial performance, possibly influenced by developments like Livdelzi's progress.
Gilead's stock has shown strong momentum, with a 25.06% price total return over the last three months. This performance may reflect market optimism about the company's pipeline, including the potential of Livdelzi in the PBC market.
For investors seeking more comprehensive analysis, InvestingPro offers 12 additional tips for Gilead Sciences, providing a deeper understanding of the company's financial health and market position.
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