Elanco Animal Health announced that the U.S. Food and Drug Administration granted conditional approval for Credelio Quattro‑CA1, a chewable tablet that combines lotilaner, moxidectin, praziquantel and pyrantel to treat New World screwworm infestations in dogs. The approval expands the company’s flagship parasite‑control portfolio to include a first‑in‑class indication for a fly larva that can cause severe tissue damage in warm‑blooded animals.
The New World screwworm, once eradicated from the United States, has re‑emerged near the U.S.–Mexico border, raising concerns for animal health in the region. By adding this indication, Elanco positions itself to address an urgent and growing threat, while reinforcing its competitive moat against rivals that lack a comprehensive seven‑parasite solution. The conditional approval allows the product to reach the market immediately, with full approval pending additional efficacy data within five years.
Elanco’s Q3 2025 results provide context for the approval’s impact. Revenue rose 10% to $1.137 billion, driven by strong demand in the Pet Health segment, which generated $533 million—an increase of 10% year‑over‑year. Adjusted EPS of $0.19 beat consensus estimates by $0.04, a 24% lift attributed to disciplined cost management and a favorable product mix that favored higher‑margin parasite‑control sales. The company raised its full‑year 2025 guidance, reflecting confidence that the new indication will contribute to continued revenue growth and margin expansion.
Elanco’s Executive Vice President of Research & Development, Dr. Ellen DeBrander, said the conditional approval “provides veterinarians, animal shelters and pet owners with an urgent, effective treatment option for a re‑emerging parasite threat.” She added that the approval “underscores Elanco’s commitment to rapid innovation and to meeting the evolving needs of animal health professionals.”
The approval is expected to accelerate sales of Credelio Quattro‑CA1 and strengthen Elanco’s pipeline, which already includes high‑margin products such as Credelio Quattro and Zenrelia. Analysts noted that the expanded portfolio aligns with the company’s strategy of delivering broad, multi‑parasite solutions, positioning Elanco to capture additional market share in the high‑margin pet‑health segment.
Overall, the FDA conditional approval marks a significant milestone for Elanco, expanding its therapeutic reach, reinforcing its competitive advantage, and supporting the company’s growth trajectory in a market that increasingly values comprehensive parasite control.
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