LIB Therapeutics, Inc. (LIB), a privately held biopharmaceutical company with a singular focus on helping high-risk patients achieve their cholesterol goals, today announced that the autoinjector for LEROCHOL® (lerodalcibep-liga) Injection 300 mg/1.2 mL, an antibody-mimetic Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitor, will launch in the United States in January 2027 at a list price, or wholesale acquisition cost (WAC), of $300 per month, the lowest list price of any PCSK9 inhibitor.1 LIB set a low list price by design, so savings reach patients at the pharmacy counter. The $199 per month direct-to-patient cash price remains unchanged and remains the lowest cash price of any PCSK9 inhibitor.2

“Recent updates to U.S. guidelines are now consistent with those worldwide and call for greater reductions in low-density lipoprotein cholesterol (LDL-C) and achievement of lower LDL-C targets,” said Evan Stein, M.D., Ph.D., Founder, CEO and Chief Scientific Officer of LIB Therapeutics. “Millions of patients cannot reach these goals on maximally tolerated statin therapy and still need substantial additional reductions only achievable with PCSK9 inhibitors. The challenge with this very effective class has been making it simple, convenient and affordable enough for patients to maintain a medication for lifelong treatment. Based on over 40 years of treating patients with elevated LDL-C, we designed LEROCHOL with the patient perspective in mind: a robust and sustained LDL-C reduction from an affordable, single, small monthly injection that patients self-administer at home, with room temperature storage for up to three months and without any food restrictions. Now with our low list price, we bring clarity and accessibility to patients, because the best medicines do little for patients who can’t access them.”

LIB is in discussions with all the major pharmacy benefit managers (PBMs) for commercial and Medicare plans as well as plan sponsors, employer groups and federal payors, including the Department of Veterans Affairs, in an effort to achieve favorable insurance coverage for and access to LEROCHOL.

“For branded medicines, patients often pay coinsurance, which is a percentage of the list price,” said Michael Adelman, Chief Commercial Officer of LIB Therapeutics. “The lower the list price, the lower the price the patient pays. This is especially important for Medicare beneficiaries, who account for approximately half of all PCSK9 inhibitor prescriptions,3 generally have fixed incomes and are not eligible to use industry co-pay cards. Our goal in establishing a low list price is to lower the out-of-pocket burden for patients so they can afford to stay on a medicine intended for lifelong therapy.”

In a study of more than 45,000 patients published in JAMA Cardiology, abandonment of PCSK9 inhibitor prescriptions rose steadily with cost, resulting in only 31% of patients prescribed the therapy ever receiving it.4

Adelman continued, “Plan sponsors, such as employers, unions, and state and municipal plans, are increasingly asking PBMs for pharmacy benefits priced transparently, with less distortion from rebates, and every major PBM now offers that option alongside its traditional rebate model. We expect the share of covered lives under low-list, low-rebate arrangements to keep growing, and LEROCHOL, with a $300 per month list price, is built for this new transparent model as the savings are already in place.”

Furthermore, the annual $2,388 cash price for LEROCHOL falls within, and the annual $3,600 list price approaches, the $2,300 to $3,400 annual value-based price range that the Institute for Clinical and Economic Review (ICER) most recently set for a PCSK9 inhibitor therapy.5

The low list and cash prices are only part of removing the barriers between patients and the care they need, and the launch of the autoinjector form of LEROCHOL will be supported by:

  • A patient assistance program for those without insurance

  • A co-pay card for commercially insured patients

  • Free overnight shipping of LEROCHOL from LIB Therapeutics’ specialty pharmacy partner, which will also help patients navigate insurance coverage

  • Assistance with connecting interested patients to independent licensed healthcare providers offering telehealth

LIB will share additional details on autoinjector availability and patient support programs ahead of the January launch of the autoinjector form. LEROCHOL requires a prescription from a licensed healthcare provider. Patients and healthcare providers interested in LEROCHOL and LEROCHOL Direct™, including the Cash-Pay Program, are encouraged to visit www.LEROCHOL.com to learn more.

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).

Cardiovascular outcomes trials have demonstrated that reducing LDL‑C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody PCSK9 inhibitors as an add-on to statin therapy.

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

About LEROCHOL® (lerodalcibep-liga)

LEROCHOL is a novel, antibody-mimetic, recombinant-fusion protein PCSK9 inhibitor and is the only PCSK9 inhibitor with a once-monthly, single, small subcutaneous injection self-administered by patients with room temperature storage 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) and 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.

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

References:

  1. Wholesale acquisition cost data, Medi-Span. Accessed October 27, 2026. Comparison includes all FDA-approved PCSK9 inhibitors.

  2. www.goodrx.com. Accessed October 26, 2026.

  3. Data on file, LIB Therapeutics. IQVIA Longitudinal Access and Adjudication Data (LAAD), PCSK9 inhibitor patients by method of payment, Q3 2023 through Q2 2026 (data through May 2026). Medicare Part D includes traditional Medicare and Medicare Advantage.

  4. Navar AM, et al. JAMA Cardiol. 2017;2(11):1217-1225. doi:10.1001/jamacardio.2017.3451. Accessed October 23, 2026.

  5. Institute for Clinical and Economic Review. Institute for Clinical and Economic Review Updates Value-Based Price Benchmark for Alirocumab. March 10, 2018.

 

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