Articles from LIB Therapeutics Inc.

LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep (Lerochol®), a novel, monthly, small dose third-generation PCSK9 inhibitor today announced results from Late Breaking Science presentations at the November 7-10th 2025 American Heart Association meeting in New Orleans.

LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep (LeroChol®), a novel, monthly, small dose third-generation PCSK9 inhibitor today announced results presented at the May 5-7 2025 European Atherosclerosis Society meeting in Glasgow.

LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) of Lerodalcibep to reduce low-density lipoprotein cholesterol (LDL-C) for the treatment of patients with atherosclerotic cardiovascular disease (ASCVD), or very high or high risk of ASCVD, and primary hyperlipidemia, including heterozygous, and those 10 years or older with homozygous familial hypercholesterolemia (HeFH / HoFH). Lerodalcibep is a novel, adnectin-based, small protein-binding, third-generation PCSK9 inhibitor, with long-ambient stability, developed as a more patient-friendly, once-monthly, self-administered, single small-volume, subcutaneous injection alternative to approved PCSK9 inhibitors. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of December 12, 2025. The FDA is not currently planning to hold an advisory committee meeting to discuss the application.

LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a novel, third-generation PCSK9 inhibitor today announced the publication of Phase 3 LIBerate-HoFH study of Lerodalcibep in a globally diverse homozygous familial hypercholesterolemia (HoFH) population was published in Lancet Diabetes & Endocrinology (Raal, F.J. et al, 2025).

LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of Lerodalcibep to reduce low-density lipoprotein cholesterol (LDL-C) for the treatment of patients with atherosclerotic cardiovascular disease (ASCVD), or very high or high risk of ASCVD, and primary hyperlipidemia, including heterozygous and homozygous familial hypercholesterolemia (HeFH / HoFH). Lerodalcibep is a novel, adnectin-based, small protein-binding, third-generation PCSK9 inhibitor, developed as a more patient-friendly, once-monthly, self-administered, single small-volume, subcutaneous injection with long-ambient stability alternative to approved PCSK9 inhibitors.

LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a novel, third-generation PCSK9 inhibitor announced positive results from two sub-studies in the LIBerate-OLE (open-label extension) study which were presented as late-breaking oral presentations at Featured Science: Novel Approaches to Managing Lipid Risk Session at American Heart Association 2024 in Chicago, Illinois on November 16.

LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a novel, once-monthly, LDL-cholesterol lowering, third-generation PCSK9 inhibitor, today announced positive results from two studies in the recently completed Phase 3 LIBerate registration-enabling program were presented during the 92nd European Atherosclerosis Society Congress in Lyon, France, May 26-29, 2024.

LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a novel, LDL-cholesterol lowering, third-generation PCSK9 inhibitor, today announced acceptance of two abstracts from the recently completed Phase 3 registration-enabling LIBerate program for presentation at the 92nd European Atherosclerosis Society Congress in Lyon, France on May 26-29, 2024.

LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a novel, LDL-cholesterol lowering, third-generation PCSK9 inhibitor, announced positive results from two studies in the recently completed Phase 3 LIBerate registration-enabling program were presented at the American College of Cardiology 2024 in Atlanta, Georgia on April 6-8, 2024.

LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a novel, LDL-cholesterol lowering, third-generation PCSK9 inhibitor, today announced that David Cory, CEO, and Evan Stein, MD, PhD, COO / CSO, will participate in a virtual fireside chat at the Piper Sandler Virtual Cardio Day on April 10, 2024 at 10:30 AM ET. Participants will include leadership from presenting companies and highlights from presentations at the American College of Cardiology 2024 in Atlanta, Georgia.

LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a novel, LDL-cholesterol lowering, third-generation PCSK9 inhibitor, today announced acceptance of two abstracts from the recently completed Phase 3 registration-enabling LIBerate program for presentation at the American College of Cardiology 2024 in Atlanta, Georgia on April 6-8, 2024.

LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a novel, LDL-cholesterol lowering, third-generation PCSK9 inhibitor, today announced acceptance of two abstracts from the recently completed Phase 3 registration-enabling LIBerate program for presentation at the American College of Cardiology 2024 in Atlanta, Georgia on April 6-8, 2024.

LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company developing Lerodalcibep, a novel, third-generation PCSK9 inhibitor in development to reduce low density lipoprotein-cholesterol (LDL-C) for patients at very high and high risk of cardiovascular disease (CVD), today announced the appointment of Ingrid Choong, PhD as Chief Business Officer.

LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company developing Lerodalcibep, a novel, third-generation PCSK9 inhibitor for patients at very high and high risk of cardiovascular disease (CVD), today announced completion of LIBerate-CVD and LIBerate-HR, the final two registration-enabling Phase 3 trials for patients with CVD or at very high and high risk of CVD. These two trials are part of the registration-enabling Phase 3 LIBerate Program which includes four key studies of 2,387 patients dosed for up to 52 weeks, with >2,200 patients continuing in an open-label extension study of 72 weeks.

LIB Therapeutics Inc. (“LIB”) and Hasten Biopharmaceutical Co., Ltd. (“Hasten”), today announce that the companies have entered into an agreement granting Hasten the rights to develop and commercialize lerodalcibep in Greater China (Chinese Mainland, Hong Kong, Macau and Taiwan). LIB is a late-stage, biopharmaceutical company developing lerodalcibep for patients at very high and high-risk of cardiovascular disease (CVD).

LIB Therapeutics Inc. (LIB), a late-stage biopharmaceutical company developing subcutaneous and oral PCSK9 inhibitor therapies for patients at very high and high-risk of cardiovascular disease (CVD), today announced that the Board of Directors has appointed David Cory as Chief Executive Officer and a member of the Board of Directors, effective immediately. Evan Stein, MD, PhD, who has served as the CEO since co-founding LIB in 2015, will continue in a full-time operational role as Chief Operating Officer and Chief Scientific Officer.

LIB Therapeutics Inc., a clinical-stage biopharmaceutical company developing subcutaneous and oral PCSK9 inhibitor medicines for patients at very high and high risk of cardiovascular disease (“CVD”) requiring additional reductions in LDL- cholesterol (“LDL-C” or “LDL”), in patients on maximally tolerated statins and other oral lipid lowering agents, announced the results of the LIBerate-HeFH trial. The results from the large global Phase 3 randomized, placebo-controlled trial, of lerodalcibep, the company’s monthly small binding protein PCSK9 inhibitor, in patients with heterozygous familial hypercholesterolemia (HeFH) were presented today at the European Society of Cardiology and simultaneously published in the European Heart Journal. https://academic.oup.com/eurheartj/article-lookup/doi/10.1093/eurheartj/ehad596