Gilead (GILD) receives FDA approval for PBC drug Livdelzi

Gilead Sciences, IncGILD 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 who are intolerant to UDCA.

The candidate was approved under the brand name Livdelzi.

PBC is a rare, chronic autoimmune disease of the bile ducts for which there is currently no cure.

PBC affects about 130,000 Americans, mostly women, and if left untreated can cause liver damage and even liver failure.

The accelerated approval was based primarily on data from the late-stage RESPONSE trial. Results showed that 62% of participants taking Livdelzi met the primary endpoint of combined biochemical response at 12 months, compared with 20% of participants taking placebo.

Treatment with Livdelzi resulted in normalization of alkaline phosphatase (ALP) levels, a cholestatic marker that predicts the risk of liver transplantation and death, in 25% of study participants at month 12.

The FDA granted accelerated approval to Livdelzi based on ALP reduction. No improvement in survival or prevention of liver decompensation events could be demonstrated. Continued approval of Livdelzi for the approved indication may be contingent on review and description of clinical benefit in the confirmatory studies.

Livdelzi must not be used in patients who have or develop decompensated cirrhosis.

Seladelpar was added to GILD's portfolio/pipeline in March 2024 through the acquisition of CymaBay Therapeutics Inc. for $4.3 billion.

Livdelzi has been granted orphan drug status in the US for the treatment of PBC patients. The FDA has also granted the drug breakthrough therapy designation. Seladelpar is currently under review in the UK and EU.

The confirmatory Phase III AFFIRM study, a randomized, placebo-controlled trial to evaluate the effect of Livdelzi on clinical outcomes in patients with compensated cirrhosis due to PBC, is currently ongoing.

There are currently two FDA-approved medications for PBC, namely UDCA and obeticholic acid.

Gilead shares have lost 8.2 percent since the beginning of the year, while the industry decline was 1.5 percent.

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The approval of Livdelzi strengthens GILD’s portfolio in liver diseases.

Last week, Gilead reported better-than-expected second-quarter results and raised its full-year earnings forecast.

The flagship HIV drug Biktarvy maintained its dominant position in key markets. The oncology business continued to perform well, but setbacks in Trodelvy's pipeline were disappointing.

The story continues

Gilead wants to strengthen and diversify its HIV portfolio.

Recent positive data on lenacapavir bodes well. According to GILD, lenacapavir's twice-yearly dosing could set a new standard for HIV prevention and allow PrEP to reach a much larger population that could benefit from a preventive regimen.

The approval of better HIV treatments should strengthen the HIV franchise in the face of increasing competition from GSK plc GSK and others.

GSK reported 13% growth in HIV sales in the second quarter, driven by strong patient demand for two drug regimens – Dovato and Juluca – as well as long-acting drugs (Cabenuva and Apretude).

Zacks Ranking and Stocks to Consider

Gilead currently has a Zacks Rank #3 (Hold). A few better-rated stocks in the biotech sector are Crystal Biotech (KRYS) And Bristol-Myers Squibb (BMY). While KRYS has a Zacks Rank #1 (Strong Buy), BMY has 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 from $2.39 to $2.07 over the past 30 days. KRYS shares are up 51.1% year-to-date.

BMY's EPS estimate for 2024 has increased 22 cents over the past 30 days to $77 cents, and for 2025 it has increased 4 cents over the past 30 days to $7.10.

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