Elanco Animal Health Incorporated
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CONTACT:
Portnoy Law Firm
Lesley F. Portnoy, Esq.,
www.portnoylaw.com
Office: 310.692.8883
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Los Angeles, CA 90067
info@portnoylaw.com
In November 2023, Elanco announced a timeline for the U.S. approval of two canine medications set for the first half of 2024: Zenrelia, an oral treatment, and Credelio Quattro, a parasiticide. However, in May 2024, the company pushed back the expected approval and commercial launch of Zenrelia to the third quarter of 2024, while also delaying Credelio Quattro’s U.S. approval to the same period, with its launch projected for the fourth quarter of 2024.
On June 27, 2024, Elanco issued a press release detailing the updated timelines for Zenrelia and Credelio Quattro’s approval by the U.S. Food and Drug Administration (FDA). The company indicated that the U.S. label for Zenrelia would likely include a boxed warning regarding safety, stemming from trial results. Elanco believed this could hinder product adoption in the U.S. and initially decrease the safe administration duration for vaccinated dogs by about 25%. The company now anticipated FDA approval for Zenrelia in the third quarter of 2024, with a possible commercial launch in the fourth quarter. Credelio Quattro was expected to receive FDA approval in the fourth quarter of 2024. Following this announcement, Elanco’s stock price dropped by $3.69 per share, approximately 20.53%, from $17.97 on June 26, 2024, to $14.28 on June 27, 2024.
The lawsuit claims that Elanco made false or misleading statements and failed to disclose critical information, specifically: (i) that Zenrelia was less safe than communicated to investors, and (ii) that the company was unlikely to meet its previously stated timeline for the approval and launch of both Zenrelia and Credelio Quattro.
The lawsuit claims that Coinbase made misleading statements and/or failed to disclose critical information, including: (1) In 2020, the FCA had determined that CBPL’s efforts to prevent criminal activity on its platform were inadequate; (2) this led to an agreement with CBPL that imposed requirements to prevent high-risk customers from accessing its services; (3) CBPL subsequently violated this agreement, allowing 13,416 high-risk individuals to use its platform; and (4) as a result, the company faced undisclosed increased regulatory risks.
