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GILD Reports Positive Results From Late-Stage Liver Disease Study
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Key Takeaways
Gilead said Livdelzi significantly improved ALP normalization versus placebo at 52 weeks in PBC.
GILD's IDEAL enrolled 96 adults; safety findings were consistent with prior Livdelzi studies.
Gilead said strong Livdelzi uptake and Hepcludex approval have bolstered its liver franchise.
Gilead Sciences, Inc. (GILD - Free Report) announced positive results from the late-stage IDEAL study in patients with primary biliary cholangitis (PBC).
Results showed that Livdelzi (seladelpar) significantly increased the proportion of patients achieving normalization of alkaline phosphatase (ALP), an important marker of liver disease progression, compared with placebo after 52 weeks.
The positive results were seen in patients with inadequately controlled PBC, characterized by ALP levels above the upper limit of normal (ULN) but below 1.67 times the ULN, despite treatment with ursodeoxycholic acid (UDCA), or in those unable to tolerate UDCA.
Although this patient group is commonly seen in clinical practice, it has historically been underrepresented in randomized clinical trials.
Livdelzi is an orally administered peroxisome proliferator-activated receptor delta (PPAR-δ) agonist. It is indicated for the treatment of PBC in combination with UDCA in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
More on GILD’s IDEAL Study Results
IDEAL is a phase III, randomized, double-blind, placebo-controlled trial evaluating Livdelzi in adults with PBC whose disease remains inadequately controlled despite treatment with UDCA who are unable to tolerate UDCA. Eligible participants had ALP levels above the ULN but below 1.67 times the ULN.
The study’s primary objective is to assess the efficacy of Livdelzi versus placebo at week 52 in achieving ALP normalization. The trial enrolled 96 adults aged 18 to 75 years.
The safety findings from the IDEAL study were consistent with the established safety profile of Livdelzi observed in previous clinical trials, with no new safety signals or unexpected adverse events reported.
PBC is a chronic autoimmune liver disorder characterized by damage to the bile ducts, affecting approximately 130,000 individuals in the United States. The condition occurs more frequently in women and, if left untreated, can lead to progressive liver damage, liver failure, and the eventual need for a liver transplant.
The FDA approved Livdelzi for PBC under accelerated approval based on a reduction of ALP. Improvement in survival or prevention of liver decompensation events has not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
Gilead intends to present the complete IDEAL study findings at a forthcoming medical conference and will work with regulatory agencies worldwide to review and discuss the results.
GILD’s Efforts to Bolster Portfolio
The strong uptake of Livdelzi has fueled liver disease franchise sales in the first quarter.
Last month, the FDA granted accelerated approval to Hepcludex (bulevirtide-gmod) for adults with chronic hepatitis delta virus (HDV) infection.
The approval makes Hepcludex the first FDA-approved therapy for HDV in the United States.
The FDA approval of Hepcludex bolsters the GILD’s liver disease franchise, which spans treatments for HCV, chronic HBV, and chronic HDV.
Gilead’s shares have gained 4% year to date against the industry's decline of 2.2%.
Image Source: Zacks Investment Research
Gilead’s first-quarter results were good. HIV business continues to maintain momentum, driven by the solid performance of Biktarvy and Descovy, and incremental contributions from Yeztugo.
Driven by increased Yeztugo sales expectations and strong first-quarter HIV performance, Gilead now projects total 2026 HIV sales growth of approximately 8% year over year, up from its prior guidance of 6% issued in February.
Approval of better HIV treatments should strengthen the HIV franchise in the wake of increasing competition from the likes of GSK plc (GSK - Free Report) .
GSK continues to grow its HIV business, driven by strong patient demand for long-acting injectable medicines (Cabenuva and Apretude) and Dovato.
GILD lowered its full-year earnings outlook due to expected acquired IPR&D charges of $11.5 billion and financing expenses associated with the Arcellx, Ouro Medicines and Tubulis GmbH deals.
Gilead’s aggressive dealmaking strategy — including the acquisition of Arcellx and agreements with Ouro and Tubulis — highlights the company’s commitment to diversifying beyond its core HIV franchise into higher-growth oncology and immunology markets. While these transactions strengthen Gilead’s long-term pipeline and growth potential, the sizable upfront payments and integration-related costs are pressuring near-term profitability.
This, in turn, has prompted Gilead to lower its EPS guidance, raising investor concerns about margin pressure and the timeline required for these acquisitions to generate meaningful returns.
Over the past 30 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have gained 60.7% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 30 days, bottom-line estimates for Immunocore have improved from a loss of 88 cents to earnings of 6 cents for 2026. Over the same period, earnings estimates for 2027 have increased to 87 cents per share from 24 cents. IMCR shares have lost 18.4% year to date.
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GILD Reports Positive Results From Late-Stage Liver Disease Study
Key Takeaways
Gilead Sciences, Inc. (GILD - Free Report) announced positive results from the late-stage IDEAL study in patients with primary biliary cholangitis (PBC).
Results showed that Livdelzi (seladelpar) significantly increased the proportion of patients achieving normalization of alkaline phosphatase (ALP), an important marker of liver disease progression, compared with placebo after 52 weeks.
The positive results were seen in patients with inadequately controlled PBC, characterized by ALP levels above the upper limit of normal (ULN) but below 1.67 times the ULN, despite treatment with ursodeoxycholic acid (UDCA), or in those unable to tolerate UDCA.
Although this patient group is commonly seen in clinical practice, it has historically been underrepresented in randomized clinical trials.
Livdelzi is an orally administered peroxisome proliferator-activated receptor delta (PPAR-δ) agonist. It is indicated for the treatment of PBC in combination with UDCA in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
More on GILD’s IDEAL Study Results
IDEAL is a phase III, randomized, double-blind, placebo-controlled trial evaluating Livdelzi in adults with PBC whose disease remains inadequately controlled despite treatment with UDCA who are unable to tolerate UDCA. Eligible participants had ALP levels above the ULN but below 1.67 times the ULN.
The study’s primary objective is to assess the efficacy of Livdelzi versus placebo at week 52 in achieving ALP normalization. The trial enrolled 96 adults aged 18 to 75 years.
The safety findings from the IDEAL study were consistent with the established safety profile of Livdelzi observed in previous clinical trials, with no new safety signals or unexpected adverse events reported.
PBC is a chronic autoimmune liver disorder characterized by damage to the bile ducts, affecting approximately 130,000 individuals in the United States. The condition occurs more frequently in women and, if left untreated, can lead to progressive liver damage, liver failure, and the eventual need for a liver transplant.
The FDA approved Livdelzi for PBC under accelerated approval based on a reduction of ALP. Improvement in survival or prevention of liver decompensation events has not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
Gilead intends to present the complete IDEAL study findings at a forthcoming medical conference and will work with regulatory agencies worldwide to review and discuss the results.
GILD’s Efforts to Bolster Portfolio
The strong uptake of Livdelzi has fueled liver disease franchise sales in the first quarter.
Last month, the FDA granted accelerated approval to Hepcludex (bulevirtide-gmod) for adults with chronic hepatitis delta virus (HDV) infection.
The approval makes Hepcludex the first FDA-approved therapy for HDV in the United States.
The FDA approval of Hepcludex bolsters the GILD’s liver disease franchise, which spans treatments for HCV, chronic HBV, and chronic HDV.
Gilead’s shares have gained 4% year to date against the industry's decline of 2.2%.
Image Source: Zacks Investment Research
Gilead’s first-quarter results were good. HIV business continues to maintain momentum, driven by the solid performance of Biktarvy and Descovy, and incremental contributions from Yeztugo.
Driven by increased Yeztugo sales expectations and strong first-quarter HIV performance, Gilead now projects total 2026 HIV sales growth of approximately 8% year over year, up from its prior guidance of 6% issued in February.
Approval of better HIV treatments should strengthen the HIV franchise in the wake of increasing competition from the likes of GSK plc (GSK - Free Report) .
GSK continues to grow its HIV business, driven by strong patient demand for long-acting injectable medicines (Cabenuva and Apretude) and Dovato.
GILD lowered its full-year earnings outlook due to expected acquired IPR&D charges of $11.5 billion and financing expenses associated with the Arcellx, Ouro Medicines and Tubulis GmbH deals.
Gilead’s aggressive dealmaking strategy — including the acquisition of Arcellx and agreements with Ouro and Tubulis — highlights the company’s commitment to diversifying beyond its core HIV franchise into higher-growth oncology and immunology markets. While these transactions strengthen Gilead’s long-term pipeline and growth potential, the sizable upfront payments and integration-related costs are pressuring near-term profitability.
This, in turn, has prompted Gilead to lower its EPS guidance, raising investor concerns about margin pressure and the timeline required for these acquisitions to generate meaningful returns.
GILD’s Zacks Rank & Key Picks
GILD currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, estimates for Liquidia’s 2026 earnings per share have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have gained 60.7% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 30 days, bottom-line estimates for Immunocore have improved from a loss of 88 cents to earnings of 6 cents for 2026. Over the same period, earnings estimates for 2027 have increased to 87 cents per share from 24 cents. IMCR shares have lost 18.4% year to date.