Esperion Therapeutics, Inc. ESPR announced that it has filed new drug submissions (NDSs) in Canada to seek approval for its once-daily, oral non-statin drugs Nexletol (bempedoic acid) and Nexlizet as a treatment to reduce low-density lipoprotein cholesterol or LDL-C (bad cholesterol) and cardiovascular risk.

Nexlizet is a combination of bempedoic acid and ezetimibe.

Shares of the company were up 10.7% on Dec. 2 following the announcement of the news.

ESPR stock has increased 3.6% so far this year against the industry’s decline of 5.2%.

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ESPR's Nexletol & Nexlizet Approved in Other Countries

Nexletol and Nexlizet are approved for treating elevated LDL-C and cardiovascular risk reduction in the United States and Europe. The drugs are marketed as Nilemdo and Nustendi in ex-U.S. markets (excluding Japan) in partnership with Daiichi Sankyo.

In March 2024, 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 study — CLEAR.

Additionally, the updated labels support the use of Nilemdo and Nustendi either alone or in combination with statins.

The European Commission approved a similar label update for Nilemdo and Nustendi in May 2024.

The inclusion of data from the CLEAR outcomes study in cardiovascular risk reduction has expanded the drugs’ label, allowing them to cater to a larger patient population.

ESPR's Nexletol & Nexlizet Demand Rising

Nexletol and Nexlizet have shown promising uptake since their launch in 2020 in the United States and Europe. Net product sales grew 46.2% year over year during the first nine months of 2024, owing to prescription growth volumes of Nexletol and Nexlizet.

The positive trend is expected to continue in 2025.

Last month, Otsuka Pharmaceutical submitted a new drug application to the Japanese Ministry of Health, Labour and Welfare for the manufacture and sale of bempedoic acid in the country for the treatment of hypercholesterolemia and familial hypercholesterolemia.

Hypercholesterolemia indicates elevated levels of cholesterol in the blood.

Esperion has a collaboration with Otsuka Pharmaceutical for the development and commercialization of Nexletol and Nexlizet tablets in Japan.

Potential approval in additional geographies like Japan and now in Canada is likely to boost sales of the drugs in future quarters.

ESPR's Zacks Rank & Key Picks

Esperion currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR, Spero Therapeutics, Inc. SPRO and Castle Biosciences, Inc. CSTL, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time. Year to date, shares of IMCR have declined 52.5%.

IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.

In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.13. Loss per share estimates for 2025 have narrowed from $1.54 to 54 cents during the same time. Year to date, shares of SPRO have declined 23.1%.

SPRO’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 94.42%.

In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 45.5%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.

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