Ligand Partner Wins FDA Nod for At-Home Heart Failure Drug
SQ Innovation's Lasix ONYU, using Ligand's technology, offers a cost-effective alternative to hospital care, boosting analyst outlooks.
Ligand Pharmaceuticals (NASDAQ: LGND) saw its shares trade near 52-week highs following news that its partner, SQ Innovation Inc., received full U.S. Food and Drug Administration (FDA) approval for Lasix ONYU. The novel drug-device combination is designed for the at-home treatment of edema in adult patients with chronic heart failure, a significant development for a condition that often requires costly hospital visits.
The approval marks a major milestone for both companies, particularly for Ligand, as Lasix ONYU is the 17th commercial product to utilize its proprietary Captisol technology. The technology is a key component in the drug's high-concentration formulation, enabling subcutaneous administration outside of a traditional healthcare setting. , the companies highlighted that the treatment provides a cost-effective alternative for patients, providers, and payers.
Wall Street reacted positively to the news, which validates Ligand's partnership-focused business model. Under the terms of its agreement, Ligand is set to receive milestone payments, low-single-digit royalties, and revenue from supplying Captisol to SQ Innovation. In response to the approval and strong company performance, , with Oppenheimer raising its target to $190, Benchmark to $175, and H.C. Wainwright setting a new target of $206.
The system, which features a reusable unit for multiple treatments, represents a meaningful step forward in patient care. SQ Innovation announced it expects to make Lasix ONYU commercially available in the fourth quarter of 2025. The full approval follows a prior 'tentative approval' issued in late 2024, which was contingent on the expiration of a competitor's market exclusivity. The successful navigation of this regulatory pathway further underscores the potential of to enable new and improved therapeutic options.