Gilead Shares Rise on Strong Long-Term Liver Drug Data
New three-year results for Livdelzi show sustained efficacy in treating rare liver disease, reinforcing the drug's potential ahead of a key FDA decision.
Gilead Sciences Inc. (NASDAQ: GILD) saw its shares climb in early trading after the biopharmaceutical giant announced positive long-term data from a Phase 3 study of its investigational liver disease drug, Livdelzi (seladelpar). The new results, which will be presented at The Liver Meeting® 2025, bolster the drug's profile as the company seeks to expand its portfolio beyond its core HIV franchise.
The stock rose to $120.66 in morning trading, reflecting investor optimism for the drug candidate aimed at treating primary biliary cholangitis (PBC), a rare and chronic inflammatory liver condition. The company, with a market capitalization of over $153 billion, is banking on new treatments in oncology and liver disease to drive future growth.
The data comes from the late-stage ASSURE study, an open-label trial evaluating the long-term safety and efficacy of Livdelzi. According to a company announcement, after three years of treatment, 85% of study participants either maintained or improved liver stiffness, a key indicator of liver scarring and disease progression.
For patients considered at high risk, the results were particularly noteworthy, showing a median reduction in liver stiffness of -5.2 kPa. This suggests Livdelzi could play a significant role in slowing the advancement of the disease in the most vulnerable populations. The study also reaffirmed the drug's ability to reduce alkaline phosphatase (ALP) levels and provide relief from pruritus, or chronic itching, a debilitating symptom of PBC.
"These long-term data are important for the PBC community and provide further evidence of Livdelzi’s potential to provide clinically meaningful improvements for people living with this rare and progressive disease," said Dr. Merdad Parsey, Chief Medical Officer at Gilead Sciences, in a statement.
This positive clinical update is the latest in a series of milestones for Livdelzi. The drug recently received conditional marketing authorization from Health Canada, marking its first regulatory approval. All eyes are now on the U.S. Food and Drug Administration (FDA), which has set a Prescription Drug User Fee Act (PDUFA) target action date of August 14, 2025, for its decision on the treatment.
Approval in the U.S. would position Gilead to compete with Intercept Pharmaceuticals' Ocaliva, the current standard of care for second-line PBC treatment. Analysts believe Livdelzi's strong efficacy and safety profile, particularly its demonstrated effect on itch relief, could make it a preferred option for both physicians and patients.
The strategic importance of Livdelzi was highlighted during Gilead's recent third-quarter earnings report, where the company emphasized the strength of its liver disease and HIV franchises. While Gilead is a dominant force in HIV therapies, it has faced pressure to diversify its revenue streams. The company's oncology division has faced headwinds, making the success of pipeline candidates like Livdelzi crucial.
Wall Street remains broadly positive on Gilead, with an average analyst price target of $129.51. The latest data is likely to reinforce this sentiment as the company approaches its pivotal FDA decision date next summer.