Tonix Pharmaceuticals stock halted ahead of FDA approval news
GREENFIELD, Ind. - Elanco Animal Health Incorporated (NYSE:ELAN), a $7.3 billion market cap company with robust financials including $4.4 billion in annual revenue and a healthy 55% gross margin, announced Thursday that its once-daily oral treatment Zenrelia (ilunocitinib) has received European Commission approval for treating itching associated with allergic dermatitis and controlling atopic dermatitis in dogs at least 12 months of age. According to InvestingPro analysis, the company maintains strong liquidity with a current ratio of 2.7.
The approval allows Elanco to begin immediate product launch in European markets, with availability expected before the end of the third quarter of 2025.
The EU authorization follows previous approvals in Brazil, Canada, Japan, and the United States, according to the company’s press release statement.
"We’re excited to bring Zenrelia to veterinarians and pet owners in Europe and provide a new solution to bring relief to itchy dogs, while changing the standard of care to a single daily dose," said Ramiro Cabral, Executive Vice President of Elanco International.
As part of the approval process, Elanco conducted a randomized, double-blind study across 25 sites in four countries involving 338 dogs with confirmed atopic dermatitis. The study compared Zenrelia to the current market incumbent JAK inhibitor, demonstrating that one daily dose of Zenrelia was at least as effective at the primary endpoint on Day 28.
The study results have been published in the peer-reviewed journal Veterinary Dermatology.
Zenrelia joins Elanco’s existing pet health portfolio in Europe, which includes products such as AdTab, Credelio, and Galliprant. The company has shown impressive momentum, with a 21.6% return over the past six months. InvestingPro analysis reveals multiple positive indicators for Elanco, with additional insights available in the comprehensive Pro Research Report, which provides deep-dive analysis of what really matters for over 1,400 top stocks.
In other recent news, Elanco Animal Health reported significant developments that are likely to interest investors. The company received USDA approval for its TruCan Ultra CIV H3N2/H3N8 vaccine, designed to protect against canine influenza strains. This vaccine showed 100% virus neutralization in studies, enhancing its appeal in the market. Additionally, Elanco’s stock ratings have been upgraded by both Leerink Partners and William Blair to Outperform, reflecting confidence in the company’s growth prospects and innovation pipeline. Leerink Partners set a price target of $18.00, while William Blair highlighted the stabilization of Elanco’s core business. Stifel also raised its price target for Elanco to $17.00, citing gains in the parasiticide market. In Europe, Elanco’s Zenrelia treatment for canine allergic dermatitis received a positive opinion from the European Medicines Agency, paving the way for market authorization. These developments indicate a strong momentum for Elanco, with various products performing well across different markets.
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