Esperion Partner HLS Therapeutics Announces Approval of NILEMDO® for the Reduction of LDL-Cholesterol in Canadians at Risk of Cardiovascular Disease
Rhea-AI Summary
Esperion (NASDAQ: ESPR) said partner HLS Therapeutics received Health Canada approval to market NILEMDO (bempedoic acid) for the reduction of LDL-cholesterol in Canadians at risk of cardiovascular disease.
Commercial launch in Canada is expected in Q2 2026. The announcement is positioned as part of Esperion's global strategy to expand access to bempedoic acid products.
The release cites Government of Canada figures that about 2.6 million adults (one in 12 aged 20+) live with diagnosed heart disease and that heart disease is the second leading cause of death in Canada, with roughly 14 adults aged 20+ dying every hour from diagnosed heart disease.
Positive
- Health Canada approval secured for NILEMDO
- Commercial launch targeted for Q2 2026
- Potential market reach: 2.6 million Canadians with diagnosed heart disease
Negative
- None.
News Market Reaction
On the day this news was published, ESPR gained 0.35%, reflecting a mild positive market reaction. This price movement added approximately $2M to the company's valuation, bringing the market cap to $643M at that time.
Data tracked by StockTitan Argus on the day of publication.
ANN ARBOR, Mich., Nov. 18, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that HLS Therapeutics Inc. (TSX: HLS), the Company’s partner in Canada for the development and commercialization of NILEMDO® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe), has received approval from Health Canada to market NILEMDO for the reduction of LDL-Cholesterol in Canadians at risk of cardiovascular disease. Commercial launch for NILEMDO is expected in Q2 2026.
“This approval marks another important milestone in our global strategy to expand access to bempedoic acid products for patients who urgently need better options to manage their LDL-C and reduce cardiovascular risk. We remain deeply committed to delivering innovative therapies that address unmet medical needs and improve outcomes for patients around the world,” said Sheldon Koenig, President and CEO of Esperion.
According to the Government of Canada, approximately one in 12 Canadian adults aged 20 and over, which represents 2.6 million people, are living with diagnosed heart disease. It is the second leading cause of death in Canada, with approximately 14 Canadian adults aged 20 and over dying every hour due to diagnosed heart disease.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a commercial stage biopharmaceutical company focused on bringing new medicines to market that address unmet needs of patients and healthcare professionals. The Company developed and is commercializing the only U.S. Food and Drug Administration (FDA) approved oral, once-daily, non-statin medicines for patients who are at risk for cardiovascular disease and are struggling with elevated low density lipoprotein cholesterol (LDL-C). These medications are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial. Esperion continues to build on its success with its next generation program which is focused on developing ATP citrate lyase inhibitors (ACLYi). New insights into the structure and function of ACLYi fully enables rational drug design and the opportunity to develop highly potent and specific inhibitors with allosteric mechanisms.
Esperion continues to evolve into a leading global biopharmaceutical company through commercial execution, international partnerships and collaborations and advancement of its pre-clinical pipeline. For more information, visit esperion.com and follow Esperion on LinkedIn and X.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization plans, current and planned operational expenses, expected profitability, future operations, commercial products, clinical development, including the timing, designs and plans for the CLEAR Outcomes study and its results, plans for potential future product candidates, financial condition and outlook, including expected cash runway and profitability, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion’s actual results to differ significantly from those projected, including, without limitation, the net sales, profitability, and growth of Esperion’s commercial products, clinical activities and results, supply chain, commercial development and launch plans, the outcomes and anticipated benefits of legal proceedings and settlements, and the risks detailed in Esperion’s filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.
Esperion Contact Information:
Investors:
Alina Venezia
investorrelations@esperion.com
(734) 887-3903
Media:
Tiffany Aldrich
corporateteam@esperion.com
(616) 443-8438
FAQ
What did Esperion (ESPR) announce on November 18, 2025 about NILEMDO?
When is NILEMDO expected to launch commercially in Canada (ESPR/HLS)?
Who is the Canadian partner for Esperion's NILEMDO (ticker ESPR) program?
What population size in Canada could NILEMDO address according to the announcement?
Does the Esperion announcement provide commercial or revenue guidance for ESPR from the Canada launch?
