CINCINNATI, Ohio, March 30th, 2026 / BUSINESS WIRE / -- LIB Therapeutics Inc. (LIB), a privately-held, biopharmaceutical company with a recently approved novel, monthly, small dose third-generation PCSK9 inhibitor, LEROCHOL® (lerodalcibep-liga), today announced results from two moderated oral poster presentations at the March 28-30, 2026 American College of Cardiology meeting in New Orleans.
“The 72-week open-label study, which over 90% of participants completed, provides further information on lerodalcibep’s longer term safety and tolerability, patient adherence, and robust and sustained reductions in LDL-C and other lipids and lipoproteins,” commented Dr David Kallend, Chief Medical Officer of LIB.
“This first trial of lerodalcibep provides large LDL-C reductions with >90% guideline target achievement rates and favorable safety in Chinese patients with hypercholesterolemia. The convenient monthly, single small-dose subcutaneous regimen, and 3-month room temperature stability addresses a significant unmet need in lipid management for patients on home dosing long-term therapy,” Commented Prof Yong Huo, Professor of Cardiovascular Medicine and Head of the Department of Cardiology at Peking University First Hospital, Beijing, China.
For full prescribing information, please visit www.LEROCHOL.com.
LEROCHOL is a novel, small protein-binding, third-generation PCSK9 inhibitor, and has been developed as a more convenient, once-monthly, home dosed, single small-volume, subcutaneous injection with extended room temperature stability up to three months. These features make lerodalcibep a unique alternative to other PCSK9 inhibitors. The anti-PCSK9 binding domain of lerodalcibep is an 11-kDa polypeptide called adnectin, engineered for high-affinity subnanomolar binding to human PCSK9 and fused to human serum albumin to enhance plasma half-life.
The FDA approval of LEROCHOL was based on data from the comprehensive global Phase 3 LIBerate Clinical Trial Program, which enrolled a diverse population of over 2,900 patients with CVD, without CVD at very high and high risk for CVD, including heterozygous and homozygous familial hypercholesterolemia. Lerodalcibep was dosed once monthly for up to 52 weeks in these key registration-enabling, placebo-controlled trials, and over 2,400 patients continued in the 72-week open-label extension trial.
In clinical trials, LEROCHOL demonstrated sustained LDL-C reductions of ≥60% in patients with, or at very high or high risk of, cardiovascular disease and ≥59% in those with HeFH who have more severe LDL-C elevations. LEROCHOL was generally well tolerated across the LIBerate Clinical Trial Program, with no treatment-related serious adverse events reported in the long-term extension studies.
LEROCHOL received marketing approval by FDA in December 2025, and it is expected to be available in the United States as a pre-filled syringe in the second quarter of 2026 with an autoinjector device expected later in the year. LIB Therapeutics is committed to working with payers, healthcare providers, and patient advocacy organizations to ensure broad access to LEROCHOL for patients who need it.
LIB Therapeutics has also submitted a Marketing Authorization Application to the European Medicines Agency, with anticipated approval in mid-2026. In Greater China, the Biologics License Application submission is expected in 1H 2026, with the potential for approval in 2027. The company is pursuing additional regulatory submissions in other markets worldwide.
LIB Therapeutics is a privately-held, commercial-stage biopharmaceutical company dedicated to bringing novel, highly effective, and safe therapies to help the millions of patients with cardiovascular disease and familial hypercholesterolemia finally achieve their LDL-C goals.
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations.
Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company’s core therapeutic areas of renal, autoimmune, critical care, cardiovascular, and ophthalmic diseases. For more information, please visit its website at www.everestmedicines.com.
In December 2025, Everest entered into a strategic agreement with Hasten Biopharmaceutical Co., Ltd. (“Hasten”), and licensing partner LIB Therapeutics, granting Everest the exclusive license to develop, register and commercialize Lerodalcibep (“LEROCHOL®”) in Greater China.
For more information, please visit: www.libtherapeutics.com.
For media inquiries:
Carly Scaduto
Carly@carlyscadutoconsulting.com
For non-media inquiries:
info@libtherapeutics.com
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