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Case Allegations:

Elanco Animal Health, a company focused on animal health products for pets and farm animals, is developing Zenrelia, a once-daily oral Janus kinase inhibitor for canine dermatology, and Credelio Quattro, a broad-spectrum parasiticide for dogs.

The class action lawsuit against Elanco Animal alleges that, during the class period, the company made false and/or misleading statements and failed to disclose crucial information regarding its products. Specifically, the lawsuit claims that: (i) Zenrelia was less safe than Elanco had represented to investors; and (ii) Elanco was unlikely to meet its previously stated timeline for the U.S. approval and commercial launch of both Zenrelia and Credelio Quattro.

The lawsuit further alleges that on June 27, 2024, Elanco revealed that it expected the U.S. label for Zenrelia to include a boxed warning on safety. This warning was based on the results of a trial involving unvaccinated dogs that were dosed at three times the labeled dose. As a result, Elanco anticipated that the product’s adoption in the U.S. would be slower than expected and that the number of treatment days (the number of days Zenrelia could safely be administered to vaccinated dogs) would be reduced by approximately 25%.

Additionally, Elanco disclosed that it now expected Zenrelia to receive FDA approval in the third quarter of 2024, with a potential commercial launch in the fourth quarter of 2024. The company also revised its expectations for Credelio Quattro, now forecasting FDA approval for the product in the fourth quarter of 2024.

Following these disclosures, Elanco’s stock price reportedly dropped by more than 20%, according to the lawsuit.