Esperion Therapeutics (ESPR – Free Report) announced that it has come to an alignment with the FDA for initiating two phase III studies. The studies will evaluate bempedoic acid alone and in combination with ezetimibe in pediatric patients with heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH). The phase III studies are expected to begin later in 2025.
Esperion markets bempedoic acid as Nexletol and Nexlizet for treating elevated LDL-C (bad cholesterol) and cardiovascular risk reduction. Nexlizet is a combination of bempedoic acid and ezetimibe.
Two separate phase III studies, namely — CLEAR Path 2 (in children with HeFH) and CLEAR Path 3 (in children with HoFH), will evaluate the safety and efficacy of bempedoic acid with and without ezetimibe in children with HeFH or HoFH and LDL-C ≥130 mg/dL who are on a protocol defined optimum dose of a statin.
In the past year, shares of Esperion have plunged 29.3% compared with the industry’s decline of 6.8%.
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More on ESPR’s Nexletol & Nexlizet
Nexletol and Nexlizet are marketed as Nilemdo and Nustendi in ex-U.S. markets (excluding Japan, where the company has a collaboration with Otsuka Pharmaceuticals) in partnership with Daiichi Sankyo. The company records royalties on sales of its drugs in ex-U.S. markets.
Esperion records revenues from product sales and collaboration revenues, which include royalties on sales of Nilemdo/Nustendi by collaboration partners.
Last March, the FDA approved label expansions for Nexletol tablets and Nexlizet tablets to include indications for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary prevention patients — based on positive data from the cardiovascular outcomes study — CLEAR.
Label Expansion of Nexletol & Nexlizet Key for ESPR
Given the lack of pipeline candidates in its portfolio, the label expansion as well as approval of Nexletol/Nexlizet into additional geographies remains a key area of focus for Esperion.
Earlier this month, the company announced that it has started developing two triple combination products with Nexletol/Nexlizet in combination with either atorvastatin or rosuvastatin.
Management believes the triple combination products may offer LDL-C lowering of more than 60%.
Regulatory applications seeking approval for Nexletol and Nexlizet are currently under review in Japan and Canada, with a potential approval expected in the second half of 2025 and the fourth quarter of 2025, respectively.
Esperion has partnered with CSL Seqirus to commercialize Nexletol and Nexlizet in Australia and New Zealand.
Net product sales of Nexletol/Nexlizet were $115.7 million in 2024, while collaboration revenues were $216.6 million. Product sales increased 47.8% year over year, while collaboration revenues were up significantly on a year-over-year basis.
ESPR’s Zacks Rank & Stocks to Consider
Esperion currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Gilead Sciences, Inc. (GILD – Free Report) , Dynavax Technologies Corporation (DVAX – Free Report) and Arvinas Inc. (ARVN – Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Gilead’s earnings per share have increased from $7.56 to $7.87 for 2025. During the same time, earnings per share have increased from $7.76 to $8.27 for 2026. In the past year, shares of GILD have rallied 45.8%.
GILD’s earnings beat estimates in each of the trailing four quarters, the average surprise being 19.47%.
In the past 60 days, estimates for Dynavax’s earnings per share have increased from 32 cents to 33 cents for 2025. During the same time, earnings per share have increased from 49 cents to 57 cents for 2026. In the past year, shares of DVAX have rallied 10.8%.
DVAX’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 9.58%.
In the past 60 days, estimates for Arvinas’ loss per share have narrowed from $4.42 to $3.49 for 2025. During the same time, loss per share has narrowed from $4.19 to $3.65 for 2026. In the past year, shares of ARVN have plunged 78.5%.
ARVN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 32.56%.
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