Maryland judge dismisses securities class action against Elanco over Zenrelia disclosures

A federal judge in Maryland dismissed a proposed securities class action against Elanco Animal Health (Elanco) this past Thursday. The lawsuit claimed that Elanco misled investors regarding the safety of its ilunocitinib tablets (Zenrelia) during development and provided an unrealistic timeline for the medication’s commercial launch.¹

US District Judge Brendan A. Hurson issued an opinion agreeing with Elanco’s argument that most of the suit’s challenged statements were protected as opinions or forward-looking statements. The judge noted that the company never made definitive promises regarding the exact timing or “future prospects” of Zenrelia.² The court found that the "vast majority" of the statements in the complaint constituted nonactionable corporate puffery, and that all statements regarding the timing of FDA approval "sound in actionable opinion."

"Defendants spoke consistently of their expectations and estimations, and that there was a 'path' to approval in the first half of 2024," Judge Hurson stated in the opinion. "And early on in the class period…defendants cautioned that their statements did not 'mean it's a guaranteed first half approval.'"

RELATED: Answering commonly asked Zenrelia questions³

According to Law360, the opinion further noted that the plaintiffs failed to provide factual allegations to support their assertion that defendants did not sincerely hold the beliefs they expressed.¹

In addition to the original allegations, the investors accused Elanco of concealing a vaccine response study. They claimed the study—which resulted in severe health problems for several dogs and the euthanasia of 2 others—was likely to negatively impact FDA approval and commercial prospects.

However, Judge Hurson found that Elanco had no legal duty to disclose the study’s existence at that stage. He concluded that the complaint failed to allege that the study would have inherently prevented Zenrelia’s approval. Furthermore, the judge ruled that the investors failed to adequately plead scienter, or proof that Elanco executives acted with the intent to deceive or with knowledge of wrongdoing.

The court also rejected accounts from an anonymous former employee (FE-1) intended to support the scienter claims.¹ According to Law360, the judge noted that FE-1 had no direct knowledge of what the defendants knew and had left the company in early 2022, before the vaccine study was even underway.

Ultimately, Judge Hurson ruled that while it is possible to infer that executives concealed the study, the "more compelling inference" is that the company offered only vague references to ongoing studies because they did not believe the results would derail the FDA approval or the treatment's commercial launch.

The original lawsuit, filed in October 2024, followed a delay in the US product launch that caused Elanco’s stock price to fall. This delay occurred after it was revealed that the medication would require specific label warnings regarding vaccine interference.¹ In September 2025, the FDA approved an updated label for Zenrelia, removing certain language regarding the risk of fatal vaccine-induced diseases after reviewing additional data submitted by the company.⁴

Editor’s Note: dvm360 reached out to Elanco for comment; the company had not responded by publication time.

Reference

1. Perera K. Elanco beats investor suit over dog drug’s reg challenges. Law360. March 26, 2026. Accessed April 3, 2026. https://www.law360.com/healthcare-authority/articles/2458121/elanco-beats-investor-suit-over-dog-drug-s-reg-challenges
2. City of Fort Lauderdale Police & Firefighters’ Retirement System v Elanco Animal Health Inc, No. 1:20-cv-01460-SAG (D Md. Mar 26, 2026).
3. McCafferty C. Answering commonly asked Zenrelia questions. dvm360. October 15, 2024. Accessed April 3, 2026. https://www.dvm360.com/view/answering-commonly-asked-zenrelia-questions
4. Bautista-Alejandra A. FDA approves updated US label for Zenrelia. dvm360. September 23, 2025. Accessed April 3, 2026. https://www.dvm360.com/view/fda-approves-updated-us-label-for-zenrelia