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HLS Therapeutics Announces Health Canada Approval of NILEMDO® for the Reduction of LDL-Cholesterol in Canadians at Risk of Cardiovascular Disease
HLS Therapeutics Announces Health Canada Approval of NILEMDO® for the Reduction of LDL-Chole...
About this update from Hls Therapeutics, Inc.
[{"type":"text","content":"\n\n\nHLS Therapeutics Announces Health Canada Approval of NILEMDO® for the Reduction of LDL-Cholesterol in Canadians at Risk of Cardiovascular Disease\n\n/* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n\n\n\n\n\nCanada NewsWire\n\n\nFirst-in-class oral treatment approved for patients requiring additional LDL-cholesterol reductionSupported by data from CLEAR Outcomes trial in nearly 14,000 patients demonstrating reduction in cardiovascular riskCommercial launch expected in Q2 2026Strengthens HLS's positioning as a leading Canadian Cardiovascular companyReceived Notice of Non-Compliance requesting additional information for NEXLIZET® (combo product) submissionTORONTO, Nov. 18, 2025 /CNW/ - HLS Therapeutics Inc. (\"HLS\" or the \"Company\") (TSX: HLS), a pharmaceutical company focused on addressing unmet needs in the treatment of psychiatric disorders and cardiovascular disease, announces that Health Canada has approved NILEMDO® (bempedoic acid) for use in Canada and has issued a Notice of Non-Compliance (\"NON\") for NEXLIZET® (bempedoic acid and ezetimibe). HLS in-licensed the exclusive rights to NILEMDO and NEXLIZET for the Canadian market from Esperion Therapeutics Inc. (\"Esperion\") (NASDAQ: ESPR) in May 2025.\nNILEMDONILEMDO (also known as NEXLETOL® in the U.S.) is a once-daily oral therapy indicated to reduce LDL-C and the risk of major cardiovascular events in adults who require additional LDL-C lowering due to an inability to reach target levels with currently available therapies or due to statin intolerance. Cardiovascular disease is the second leading cause of death in Canada1, yet many high-risk patients still cannot achieve guideline-recommended LDL-C targets. As a result, more than half a million Canadians may benefit from bempedoic acid2.\nDr. George Thanassoulis, MD, MSc, FRCPC, Professor of Medicine (Cardiology) at McGill University and a co-lead author of the Canadian Cardiovascular Society Lipid Guidelines, said, \"Too many Canadians are unable to reach their LDL-C targets, even when following recommended treatments. NILEMDO (bempedoic acid) r...