Gilead Sciences, Inc. GILD announced positive interim results from the ongoing ASSURE study on pipeline candidate seladelpar.
ASSURE is an open-label study evaluating the long-term safety and efficacy of seladelpar, a once-daily potent and selective peroxisome proliferator-activated receptor (PPAR) delta agonist or delpar.
Seladelpar is a first-in-class oral, selective PPAR-delta agonist or delpar is being evaluated for treating primary biliary cholangitis (PBC).
The study enrolled adult patients with PBC who previously participated in a study of seladelpar where a key eligibility criterion included an inadequate response or intolerance to ursodeoxycholic acid (UDCA). Most patients enrolled in ASSURE were female (94%), with a mean age of 59 years.
PBC is a rare, chronic, cholestatic liver disease mainly affecting women.
We remind investors that the candidate was added to Gilead’s pipeline following the recent acquisition of CymaBay Therapeutics, Inc.
The interim results showed that treatment with seladelpar led to improvements in markers of cholestasis and reduced inflammation. Additional findings demonstrate that seladelpar can help reduce pruritus (itch) in people living with PBC.
This analysis did not include patients from the late-stage RESPONSE study, which will be reported separately.
The study also evaluated several prespecified biochemical endpoints, including the composite response of alkaline phosphatase (ALP) below 1.67 x upper limit of normal (ULN), a decline in ALP of at least 15% and total bilirubin (TB) below the ULN.
70% of patients receiving seladelpar 10mg achieved the clinically meaningful composite endpoint and 37% achieved ALP normalization at 12 months.
The reduction in patient-reported pruritus was rapid and durable in patients with moderate to severe symptoms.
Please note that a new drug application (NDA) for seladelpar for the treatment of PBC, including pruritus, in adults without cirrhosis or with compensated cirrhosis (Child Pugh A) who are inadequate responders or intolerant to UDCA is under review in the United States.
The FDA granted priority review to the NDA and set a target action date of Aug 14, 2024. The candidate is also under review in Europe.
Seladelpar received FDA Breakthrough Therapy Designation for the treatment of PBC, including pruritus in patients without cirrhosis or with compensated cirrhosis and PRIME status (EMA) and Orphan Drug Designation in the United States and Europe for treating patients with PBC.
Gilead’s shares have lost 16.4% year to date compared with the industry‘s decline of 5%.
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Last month, GILD reported better-than-expected results for the first quarter of 2024 as its loss was narrower than expected and sales beat estimates.
Gilead Sciences, Inc. Price, Consensus and EPS Surprise
Gilead Sciences, Inc. price-consensus-eps-surprise-chart | Gilead Sciences, Inc. Quote
The company intends to expand its portfolio beyond the HIV franchise. The acquisition of CymaBay complements Gilead’s existing liver portfolio and a potential approval of seladelpar for PBC will strengthen this franchise.
Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) received accelerated approval from the FDA in 2016 for the treatment of adult patients living with PBC without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with UDCA with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.
Zacks Rank & Stocks to Consider
Gilead currently carries a Zacks Rank #5 (Strong Sell).
A couple of better-ranked stocks from the healthcare industry are Ligand Pharmaceuticals LGND and ANI Pharmaceuticals ANIP. Both stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2024 and 2025 earnings per share (EPS) has remained constant at $4.56 and $5.27, respectively. Shares of LGND are up 20.5% year to date.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have improved from $4.43 to $4.44. Shares of ANIP have jumped 11.4% year to date. ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an earnings surprise of 53.90%, on average.
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