FDA approves SQ Innovation’s Lasix ONYU for at-home heart failure treatment

JUPITER, Fla. - SQ Innovation Inc. has received U.S. Food and Drug Administration approval for Lasix ONYU, a novel drug-device combination that allows heart failure patients to receive furosemide injections at home, according to a press release from Ligand Pharmaceuticals Incorporated (NASDAQ:LGND). The company’s stock, trading near its 52-week high of $186.40, has delivered an impressive 78.7% return over the past year.

The newly approved treatment combines a high-concentration formulation of furosemide with a small infusion device for subcutaneous administration outside healthcare settings. The system features a reusable unit that can deliver 48 treatments and a disposable sterile component.

Ligand’s Captisol technology is a key component of the formulation, enabling the high concentration of 30mg/mL furosemide. This marks the 17th approved product utilizing Captisol, which enhances drug solubility, stability and bioavailability. According to InvestingPro data, Ligand maintains strong financial health with a current ratio of 5.45, indicating robust operational efficiency.

The treatment targets edema due to fluid overload in adult patients with chronic heart failure. These patients would typically require hospitalization for intravenous diuretic treatment, but can now potentially receive comparable therapy at home.

Heart failure affects approximately 6.7 million Americans, with prevalence expected to increase to 8.7 million by 2030. The condition accounts for roughly 1.2 million hospitalizations annually among people 65 and older. Ligand appears well-positioned to capture this growing market, with revenue growth of 40.54% in the last twelve months. For deeper insights into Ligand’s market position and growth potential, check out the comprehensive analysis available on InvestingPro, which offers exclusive access to over 30 key financial metrics and expert ProTips.

Ligand entered into exclusive worldwide Captisol license and supply agreements with SQ Innovation in 2019. Under the terms, Ligand will supply Captisol for the formulation and receive milestone payments, a low-single-digit royalty, and revenue from material sales.

SQ Innovation plans to make Lasix ONYU available in the fourth quarter of 2025.

In other recent news, Ligand Pharmaceuticals has been at the center of several significant developments. The company completed a $460 million convertible notes offering, which included an option for initial purchasers to buy an additional $60 million in notes. This capital raise resulted in approximately $445.1 million in net proceeds after fees and expenses. In light of these financial moves, Oppenheimer raised its price target for Ligand Pharma to $190, citing a lower weighted average cost of capital (WACC) as a reason for the adjustment. Benchmark also increased its price target to $175, attributing this change to Ligand’s strong second-quarter 2025 earnings report. Furthermore, H.C. Wainwright raised its price target to $206 following an FDA-approved update to the REMS labeling for FILSPARI, which reduced liver function monitoring requirements. These updates reflect a series of strategic financial and regulatory advancements for Ligand Pharmaceuticals.

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