LIB Therapeutics Launches LEROCHOL^® (lerodalcibep-liga) in the United States with a Patient-First Approach to Access and Affordability

Once-monthly, third-generation PCSK9 inhibitor now available with direct-to-patient cash-pay option at $199 per month, a substantial discount to other PCSK9 inhibitors direct-to-patient cash prices^1,2

CINCINNATI, Ohio – May 11, 2026 – LIB Therapeutics Inc. (LIB), a privately held biopharmaceutical company, today announced the U.S. commercial launch of LEROCHOL^® (lerodalcibep-liga) Injection 300 mg/1.2 mL, a once-monthly, self-administered third-generation Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitor. LEROCHOL is FDA approved as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).

The launch features a direct-to-patient cash-pay option priced at $199 per month, a substantial discount to other PCSK9 inhibitor cash prices. LEROCHOL is now available in a prefilled syringe, and LIB expects the FDA approval of LEROCHOL in an auto-injector pen later this year.

LEROCHOL is different from other PCSK9 inhibitors because it’s the only one with once-monthly, single injection, self-administered dosing. LEROCHOL is also a small-binding protein, not a monoclonal antibody, and offers extended room temperature stability for up to three months for patients.

“Cardiovascular disease remains the leading cause of death in the United States, and elevated LDL-C is among its most modifiable drivers. Patients who need lower LDL-C levels deserve a clear and affordable path to effective therapies that are also convenient to support long term adherence. With LEROCHOL, we’re delivering a once-monthly therapy with robust, sustained LDL-C reductions of up to 60% at the best PCSK9 inhibitor cash price,” said Michael Adelman, Chief Commercial Officer of LIB Therapeutics. “We’ve priced LEROCHOL the way we believe medicine should be priced: transparently and predictably, with a focus on value to patients. It’s a meaningful step for patients today, and it sets the stage for our broader commercial launch ahead.”

LIB’s pricing philosophy is grounded in transparency and delivering value to patients. By offering high-value therapies with a low list price, LIB aims to lower out-of-pocket costs, simplify access, and reduce the systemic distortions that often drive up what patients pay at the pharmacy counter. LIB welcomes partnerships with self-insured employers, transparent pharmacy benefit managers, and other healthcare partners that share its commitment to clear, predictable pricing. LIB believes this approach reflects a broader shift toward transparent drug pricing across the U.S. healthcare system and will ultimately lead to easier patient adherence to medications and more durable achievement of LDL-C goals.

LEROCHOL requires a prescription from a licensed healthcare provider. Patients and healthcare providers interested in LEROCHOL and the cash-pay program are encouraged to visit www.LEROCHOL.com to learn more. The introduction of LEROCHOL in a pre-filled syringe lays the groundwork for a broader commercial introduction of LEROCHOL, with the auto-injector formulation expected to be approved by the FDA later this year. LIB will share additional details on timing, access, and commercial scope as those plans are finalized. In the meantime, the company remains focused on ensuring a smooth experience for physicians and patients who are adopting LEROCHOL today.

IMPORTANT SAFETY INFORMATION

Adverse Reactions

• The most commonly occurring adverse reactions in clinical trials in primary hyperlipidemia in adults (including heterozygous familial hypercholesterolemia [HeFH]) (≥2% of patients treated with LEROCHOL^® (lerodalcibep-liga) and occurring more frequently than with placebo) were nasopharyngitis (15% and 14% versus placebo), local injection site reactions (12% and 5% versus placebo) and peripheral edema (2% and <1% versus placebo).
• The most commonly occurring adverse reactions in clinical trials in HeFH (≥2% of patients treated with LEROCHOL and occurring more frequently than with placebo) were injection site reactions (18% and 3% versus placebo), nasopharyngitis (13% and 9% versus placebo), diarrhea (3% and 1% versus placebo), nausea (2% and 0% versus placebo) and peripheral edema (2% and <1% versus placebo).
• The most frequent adverse reaction leading to treatment discontinuation in trials in primary hypercholesterolemia in adults was injection site reactions, with a higher frequency in the LEROCHOL-treated group compared to placebo-treated patients (1% vs. 0%).

Immunogenicity

• LEROCHOL is a recombinant fusion protein. As with all therapeutic proteins, there is potential for immunogenicity with LEROCHOL.

INDICATIONS

LEROCHOL^® (lerodalcibep-liga) is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).

For full prescribing information, please visit www.LEROCHOL.com.

About LEROCHOL^® (lerodalcibep-liga)

LEROCHOL is a novel, small protein-binding, third-generation PCSK9 inhibitor, and has been developed as a convenient, once-monthly, self-administered, single small-volume, subcutaneous injection with extended room temperature stability up to three months. These features make LEROCHOL a unique alternative to other PCSK9 inhibitors. The anti-PCSK9 binding domain of LEROCHOL is an 11-kDa polypeptide called an adnectin, engineered for high-affinity subnanomolar binding to human PCSK9, and fused to human serum albumin to enhance plasma half-life.

About the LIBerate Clinical Trial Program^™

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 cardiovascular disease (CVD), without CVD at very high and high risk for CVD, including heterozygous and homozygous familial hypercholesterolemia (HeFH). LEROCHOL 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 serious treatment-related adverse events reported in the long-term extension studies.

About LIB Therapeutics, Inc.

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. The company has also submitted a Marketing Authorization Application to the European Medicines Agency, with anticipated approval in 2H 2026. In Greater China, the Biologics License Application submission is expected in 1H 2026, with potential approval in 2027. LIB is pursuing additional regulatory submissions in other markets worldwide.

For more information, please visit: www.libtherapeutics.com.

References

1. https://www.goodrx.com/repatha, Accessed May 1, 2026.

2. Regeneron Press Release, April 23, 2026. Accessed May 1, 2026.

Contacts

For media inquiries:
Carly Scaduto
Carly@carlyscadutoconsulting.com

For non-media inquiries:
Info@libtherapeutics.com