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Gilead (GILD) Obtains FDA Approval for PBC Drug Livdelzi
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Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA has granted accelerated approval to seladelpar for the treatment of primary biliary cholangitis (PBC), in combination with ursodeoxycholic acid (UDCA), in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
The candidate was approved under the brand name Livdelzi.
PBC is a rare, chronic, autoimmune disease of the bile ducts that currently has no cure.
PBC affects approximately 130,000 Americans, primarily women, and can cause liver damage and even liver failure if left untreated.
The accelerated approval was primarily based on data from the late-stage RESPONSE study. Results showed that 62% of participants taking Livdelzi achieved the primary endpoint of composite biochemical response at month 12 compared to 20% of participants taking placebo.
Treatment with Livdelzi led to the normalization of alkaline phosphatase (ALP) values, a cholestatic marker that is a predictor of risk for liver transplant and death, in 25% of trial participants at month 12.
The accelerated approval was granted by the FDA to Livdelzi based on a reduction of ALP. Improvement in survival or prevention of liver decompensation events has not been demonstrated. Continued approval of Livdelzi for the approved indication may be contingent on verification and description of clinical benefit in the confirmatory trial(s).
Livdelzi cannot be used for patients who have or develop decompensated cirrhosis.
Seladelpar was added to GILD’s portfolio/pipeline through the acquisition of CymaBay Therapeutics Inc. for $4.3 billion in March 2024.
Livdelzi enjoys Orphan Drug Designation for the treatment of PBC patients in the United States. It was also granted Breakthrough Therapy Designation by the FDA. Seladelpar is also under review in the UK and EU.
The confirmatory phase III AFFIRM study, a randomized, placebo-controlled study designed to evaluate the effect of Livdelzi on clinical outcomes in people with compensated cirrhosis due to PBC, is currently ongoing.
At present, there are two FDA-approved medicines for PBC, namely UDCA and obeticholic acid.
Gilead’s shares have lost 8.2% year to date compared with the industry's decline of 1.5%.
The approval of Livdelzi strengthens GILD’s liver disease portfolio.
Last week, Gilead reported better-than-expected second-quarter results and raised its annual earnings guidance.
Flagship HIV treatment Biktarvy maintained its dominant position for HIV across major markets. The oncology business continued to perform well, but pipeline setbacks for Trodelvy were a disappointment.
Gilead is looking to strengthen its HIV portfolio and simultaneously diversify its portfolio.
The recent positive data on lenacapavir bodes well. Per GILD, lenacapavir, with its twice-yearly dosing, could set a new bar for HIV prevention and allow PrEP to reach a much broader population of people who could benefit from a prevention regimen.
Approval of better HIV treatments should strengthen the HIV franchise in the wake of the increasing competition from GSK plc (GSK - Free Report) and others.
GSK posted 13% growth in HIV sales in the second quarter, driven by strong patient demand for two drug regimens — Dovato and Juluca — and long-acting drugs (Cabenuva and Apretude).
Zacks Rank & Stocks to Consider
Gilead currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector are Krystal Biotech (KRYS - Free Report) and Bristol Myers Squibb (BMY - Free Report) ). While KRYS sports a Zacks Rank #1 (Strong Buy), BMY carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Krystal Biotech’s earnings per share (EPS) estimate for 2024 has decreased to $2.07 from $2.39 in the past 30 days. Shares of KRYS have surged 51.1% year to date.
BMY’s EPS estimate for 2024 has increased 22 cents to 77 cents in the past 30 days, and the same for 2025 has increased 4 cents to $7.10 in the past 30 days.
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Gilead (GILD) Obtains FDA Approval for PBC Drug Livdelzi
Gilead Sciences, Inc. (GILD - Free Report) announced that the FDA has granted accelerated approval to seladelpar for the treatment of primary biliary cholangitis (PBC), in combination with ursodeoxycholic acid (UDCA), in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
The candidate was approved under the brand name Livdelzi.
PBC is a rare, chronic, autoimmune disease of the bile ducts that currently has no cure.
PBC affects approximately 130,000 Americans, primarily women, and can cause liver damage and even liver failure if left untreated.
The accelerated approval was primarily based on data from the late-stage RESPONSE study. Results showed that 62% of participants taking Livdelzi achieved the primary endpoint of composite biochemical response at month 12 compared to 20% of participants taking placebo.
Treatment with Livdelzi led to the normalization of alkaline phosphatase (ALP) values, a cholestatic marker that is a predictor of risk for liver transplant and death, in 25% of trial participants at month 12.
The accelerated approval was granted by the FDA to Livdelzi based on a reduction of ALP. Improvement in survival or prevention of liver decompensation events has not been demonstrated. Continued approval of Livdelzi for the approved indication may be contingent on verification and description of clinical benefit in the confirmatory trial(s).
Livdelzi cannot be used for patients who have or develop decompensated cirrhosis.
Seladelpar was added to GILD’s portfolio/pipeline through the acquisition of CymaBay Therapeutics Inc. for $4.3 billion in March 2024.
Livdelzi enjoys Orphan Drug Designation for the treatment of PBC patients in the United States. It was also granted Breakthrough Therapy Designation by the FDA. Seladelpar is also under review in the UK and EU.
The confirmatory phase III AFFIRM study, a randomized, placebo-controlled study designed to evaluate the effect of Livdelzi on clinical outcomes in people with compensated cirrhosis due to PBC, is currently ongoing.
At present, there are two FDA-approved medicines for PBC, namely UDCA and obeticholic acid.
Gilead’s shares have lost 8.2% year to date compared with the industry's decline of 1.5%.
Gilead Sciences, Inc. Price and Consensus
Gilead Sciences, Inc. price-consensus-chart | Gilead Sciences, Inc. Quote
The approval of Livdelzi strengthens GILD’s liver disease portfolio.
Last week, Gilead reported better-than-expected second-quarter results and raised its annual earnings guidance.
Flagship HIV treatment Biktarvy maintained its dominant position for HIV across major markets. The oncology business continued to perform well, but pipeline setbacks for Trodelvy were a disappointment.
Gilead is looking to strengthen its HIV portfolio and simultaneously diversify its portfolio.
The recent positive data on lenacapavir bodes well. Per GILD, lenacapavir, with its twice-yearly dosing, could set a new bar for HIV prevention and allow PrEP to reach a much broader population of people who could benefit from a prevention regimen.
Approval of better HIV treatments should strengthen the HIV franchise in the wake of the increasing competition from GSK plc (GSK - Free Report) and others.
GSK posted 13% growth in HIV sales in the second quarter, driven by strong patient demand for two drug regimens — Dovato and Juluca — and long-acting drugs (Cabenuva and Apretude).
Zacks Rank & Stocks to Consider
Gilead currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector are Krystal Biotech (KRYS - Free Report) and Bristol Myers Squibb (BMY - Free Report) ). While KRYS sports a Zacks Rank #1 (Strong Buy), BMY carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Krystal Biotech’s earnings per share (EPS) estimate for 2024 has decreased to $2.07 from $2.39 in the past 30 days. Shares of KRYS have surged 51.1% year to date.
BMY’s EPS estimate for 2024 has increased 22 cents to 77 cents in the past 30 days, and the same for 2025 has increased 4 cents to $7.10 in the past 30 days.