Zenrelia (ilunocitinib)

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Elanco Animal Health Gets Its Bite Back, Pipeline Efforts Earn Praise
Benzinga· 2025-06-26 18:38
Core Viewpoint - Elanco Animal Health Incorporated appears to be turning a corner after years of market share losses and uneven execution, with a stabilized core business and promising innovation pipeline [1][2]. Business Performance - Investor meetings hosted by William Blair have led to an upgrade of Elanco's stock, highlighting the stabilization of the core business, which constitutes about 85% of sales, due to improved execution [2][3]. - The company's recent product launches in both livestock and pet health are expected to enhance growth, potentially contributing around five percentage points to overall growth in 2025 [4]. Product Pipeline and Innovation - Elanco's Zenrelia (ilunocitinib) received a positive opinion from the European Medicines Agency, with expectations for market approval and supply before the end of Q3 [5]. - New farm animal products like Bovaer and Experior, which currently face little to no competition, may increase demand for older products such as Rumensin [5]. Competitive Landscape - Elanco faces significant competition from larger, well-funded companies like Merck and Zoetis, which are also heavily investing in new product development [6]. - Merck's JAK inhibitor could impact the performance of Elanco's Zenrelia, as it is expected to have fewer safety concerns, while Zoetis has a strong track record of improving existing products [6]. Stock Performance - Elanco's stock is currently up 3.05%, trading at $14.18 [7].
Elanco Receives Positive Opinion on Zenrelia (ilunocitinib) from EU's Committee for Veterinary Medicinal Products (CVMP)
Prnewswire· 2025-06-12 20:17
Core Viewpoint - Elanco Animal Health has received a positive opinion from the European Medicines Agency for its product Zenrelia, which is expected to receive marketing authorization in the EU within 60 days [1][2]. Group 1: Product Details - Zenrelia (ilunocitinib) is effective in treating pruritus associated with allergic dermatitis and clinical manifestations of atopic dermatitis in dogs [2]. - The product has already been approved in markets outside the United States, including Brazil, Canada, Japan, and the United States, with additional approvals anticipated in Australia and the United Kingdom in 2025 [3]. Group 2: Regulatory Milestones - The positive opinion from the CVMP is based on the quality, safety, and efficacy data submitted by Elanco, demonstrating a favorable benefit-risk balance [2]. - Elanco has conducted a head-to-head non-inferiority study against the current market leader, yielding positive results [3]. Group 3: Market Launch Expectations - The company expects to launch Zenrelia shortly after receiving marketing authorization, with product supply anticipated in the market before the end of the third quarter of 2025 [3].