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Elanco (ELAN) Faces Securities Class Action Lawsuit Over Alleged Safety Risks of Zenrelia – Hagens Berman

Key Takeaway: Elanco (ELAN) is the subject of a securities class action lawsuit due to allegations of misrepresenting safety risks associated with its oral Janus kinase inhibitor, Zenrelia. The lawsuit claims that the company overstated the drug's market potential while minimizing safety concerns. Recent disclosures revealed that Zenrelia would include a boxed warning and that the company anticipates delays in obtaining FDA approval. As a result, Elanco's stock experienced a significant drop of over 20% in value.

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CONCERNS & RISKS

  • Elanco is facing allegations of downplaying safety risks associated with Zenrelia.
  • The company is unlikely to meet previously issued timelines for drug approval and launch.
  • The announcement that Zenrelia will have a boxed warning raised concerns about its safety and market viability.
  • Elanco's stock price dropped over 20% following the disclosure of safety issues.

Full Press Release Details

SAN FRANCISCO, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Animal health company Elanco (ELAN) and its most senior executives are the targets of a securities class action suit, alleging that they downplayed potential safety concerns related to Elanco’s new oral Janus kinase inhibitor, Zenrelia, while overstating its prospects for a rapid U.S. market entry.
Hagens Berman urges Elanco Animal Health Incorporated (NYSE: ELAN) investors who suffered substantial losses to submit your losses now.
Class Period: Nov. 7, 2023 – June 26, 2024
Lead Plaintiff Deadline: Dec. 6, 2024
Contact the Firm Now: ELAN@hbsslaw.com
Class Action Lawsuit Against Elanco Animal Health Incorporated (ELAN):
Elanco is an animal health company that develops, manufactures, and markets products for pets and farm animals. The Company is developing, among other drugs, Zenrelia, a "safe, highly effective, and convenient" once-daily oral Janus kinase inhibitor for canine dermatology, and Credelio Quattro, a broad spectrum parasiticide product for dogs.
In November 2023, Elanco set a timeline for U.S. approval of both Zenrelia and Credelio Quattro in the first half of 2024.
Then, in May 2024, Elanco set a timeline for the U.S. approval and commercial launch of Zenrelia in third quarter of 2024, as well as the U.S. approval of Credelio Quattro in the third quarter of 2024 with a commercial launch set for the fourth quarter of 2024.
The complaint alleges that Defendants misrepresented and failed to disclose that: (i) Zenrelia was less safe than the Company had led investors to believe; (ii) Elanco was unlikely to meet its own previously issued timeline for the U.S. approval and commercial launch of both Zenrelia and Credelio Quattro; and (iii) accordingly, the Company’s business and/or financial prospects were overstated.
Defendants’ façade began to crack on June 26, 2024, when Elanco disclosed that Zenrelia's label would feature a boxed warning. This warning underscored safety issues identified during trials with unvaccinated dogs, sparking concerns about the drug's market viability. Further, Elanco stated that it was now expecting Zenrelia to receive FDA approval in the third quarter of 2024, leading to a potential commercial launch in the fourth quarter of 2024, and that Credelio Quattro is expected to receive FDA approval in the fourth quarter of 2024 The announcement sent shockwaves through the financial market, with Elanco's stock plunging by over 20%.
Later, during the company's second-quarter earnings call on August 4, 2024, CEO Jeffrey N. Simmons acknowledged that the label's cautionary language would "slow the initial product adoption curve," necessitating extensive veterinary education. He further projected a 25% reduction in treatment days, citing anticipated constraints related to vaccine requirements stipulated in the boxed warning.
In light of these revelations, the law firm Hagens Berman has launched an investigation into the allegations, seeking to hold Elanco accountable for potentially misleading investors and minimizing critical safety risks.
"Our focus is on determining whether Elanco's representations about Zenrelia's safety were accurate and truthful," said Reed Kathrein, lead partner at Hagens Berman.
If you invested in Elanco Animal Health and have substantial losses submit your losses now »
If you’d like more information and answers to frequently asked questions about the Elanco case and our investigation, read more »
Whistleblowers: Persons with non-public information regarding Elanco should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email ELAN@hbsslaw.com.
Hagens Berman is a global plaintiffs’ rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman’s team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.
Reed Kathrein, 844-916-0895

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Frequently Asked Questions

What is the lawsuit against Elanco about?

The lawsuit claims Elanco misrepresented safety concerns related to Zenrelia.

What products is Elanco developing?

Elanco is developing Zenrelia, a Janus kinase inhibitor, and Credelio Quattro.

When is the lead plaintiff deadline for the class action?

The lead plaintiff deadline is December 6, 2024.

What warnings were issued about Zenrelia?

Zenrelia's label includes a boxed warning highlighting safety issues.

How has Elanco's stock reacted to the news?

Elanco's stock dropped over 20% following the disclosure of safety concerns.

Last updated: Dec 4, 2024