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GREENFIELD, Ind. - Elanco Animal Health Incorporated (NYSE:ELAN), a $7 billion market cap animal health company with annual revenues exceeding $4.4 billion, announced Thursday that its canine allergic dermatitis treatment Zenrelia (ilunocitinib) received a positive opinion from the European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP).
The positive recommendation positions the product for marketing authorization in the European Union within the next 60 days. Elanco expects to launch Zenrelia in EU markets before the end of the third quarter, according to the company’s press release statement. According to InvestingPro data, the company maintains strong liquidity with a current ratio of 2.71, suggesting robust operational capability for product launches.
The CVMP cited Zenrelia’s efficacy in treating pruritus associated with allergic dermatitis and clinical manifestations of atopic dermatitis in dogs. The committee recommended approval based on quality, safety, and efficacy data demonstrating a favorable benefit-risk balance.
"This milestone marks a significant advancement in the expansion of Zenrelia," said Dr. Ellen de Brabander, Executive Vice President of Innovation and Regulatory Affairs at Elanco.
The veterinary medication has already received regulatory approvals in Brazil, Canada, Japan, and the United States. The company anticipates additional approvals in Australia and the United Kingdom in 2025. With the stock showing strong momentum and up nearly 18% year-to-date, InvestingPro analysis reveals 8 additional key indicators that could impact investor decisions. Get the full analysis and discover if Elanco is currently undervalued in the comprehensive Pro Research Report, available exclusively to subscribers.
As part of the EU approval process, Elanco conducted a head-to-head non-inferiority study comparing Zenrelia to the current market leader.
Once approved, Zenrelia’s European label will align with its labeling in other markets outside the United States where the product has already received authorization.
In other recent news, Elanco Animal Health reported stronger-than-expected earnings for the first quarter of 2025, with adjusted earnings per share (EPS) of $0.37, surpassing the forecast of $0.31. The company’s revenue reached $1.19 billion, slightly above the anticipated $1.17 billion. Following this performance, Elanco raised its full-year revenue guidance, attributing the adjustment to favorable foreign exchange rates. In addition, TD Cowen increased Elanco’s stock price target to $15.00, maintaining a Buy rating based on the company’s robust first-quarter performance and raised revenue estimates for 2025. Stifel also raised their price target for Elanco to $15.00, citing strong quarterly performance and promising prospects for the company’s innovative products. Leerink Partners, while raising the price target for Elanco to $14.50, maintained a Market Perform rating due to uncertainties about the uptake of new products like Zenrelia. Elanco has also appointed Robert VanHimbergen as the new Executive Vice President and Chief Financial Officer, effective July 7, 2025, as part of its strategy to strengthen its financial leadership and drive growth.
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