Core Viewpoint - Elanco Animal Health is committed to enhancing veterinary and pet owner education following a warning letter from the U.S. FDA regarding misleading promotional practices related to its product Zenrelia [1][3][5]. Group 1: FDA Warning Letter - The FDA issued a warning letter to Elanco concerning misleading claims in promotional materials for Zenrelia (ilunocitinib tablets), which misbrands the product under the Federal Food, Drug, and Cosmetic Act [3][11][22]. - The letter highlights that the promotional communications create a misleading impression about the safety and effectiveness of Zenrelia, particularly regarding its use in dogs [11][12][22]. - Elanco is required to address the concerns raised in the letter and submit a written response within 15 working days [26][27]. Group 2: Product Information and Safety - Zenrelia is indicated for controlling itching and inflammation associated with skin allergies in dogs over 12 months of age [6][12]. - The FDA-approved prescribing information includes a boxed warning about the risk of fatal vaccine-induced disease and inadequate immune response to vaccines in dogs receiving Zenrelia [8][12][13]. - The promotional materials omitted critical safety information, including specific timeframes for withholding Zenrelia before and after vaccination, which is misleading for pet owners [16][17][18]. Group 3: Company Response and Future Outlook - Elanco is actively reviewing and updating Zenrelia's promotional materials in response to the FDA's concerns and does not expect these adjustments to materially impact Zenrelia's revenue [4][5]. - The company anticipates accelerating organic constant currency revenue growth in the mid-single digits for 2025 [5]. - Elanco emphasizes its dedication to helping veterinarians and pet owners understand the benefits of Zenrelia while ensuring compliance with regulatory standards [2][4].

Core Points - Elanco Animal Health Incorporated will announce its fourth quarter and full year 2024 financial results on February 25, 2025 [1] - A conference call will be held on the same day at 8:00 a.m. eastern time for investors, media, and the public to discuss the company's performance [2] - Elanco is a global leader in animal health, focusing on innovating products and services for the prevention and treatment of diseases in farm animals and pets [3] Company Overview - Elanco has a 70-year heritage in animal health and aims to create value for farmers, pet owners, veterinarians, and society [3] - The company is committed to improving animal health while making a positive impact on local and global communities [3] - Elanco's vision emphasizes the importance of food and companionship in enriching life, supported by its sustainability pillars [3]

Core Insights - Elanco Animal Health has launched Zenrelia, a once-daily oral JAK inhibitor for dogs suffering from allergic dermatitis, which was approved by the FDA in September 2024 [1][2][12] - Approximately 17 million dogs in the U.S. are affected by allergic skin diseases, highlighting a significant market opportunity for effective treatments like Zenrelia [1][2] - A clinical trial involving over 300 allergic dogs demonstrated Zenrelia's effectiveness compared to the leading JAK inhibitor, Apoquel [2][8] Company Overview - Elanco Animal Health is a global leader in animal health, focusing on innovative products and services for disease prevention and treatment in both farm animals and pets [11] - The company emphasizes its commitment to improving animal health and creating value for various stakeholders, including pet owners and veterinarians [11] Product Details - Zenrelia is indicated for controlling itching and inflammation associated with skin allergies in dogs over 12 months of age [12] - The product is designed to start working from the first dose, providing quick relief for dogs suffering from allergic itch [2][4] Market Impact - A survey indicated that 82% of pet owners with itchy dogs are eager for effective treatment solutions, suggesting a strong demand for products like Zenrelia [4] - Real-world results from pet owners show significant improvements in their dogs' conditions after using Zenrelia, reinforcing its market potential [4][9] Clinical Evidence - A newly published study in Veterinary Dermatology compared the clinical outcomes of Zenrelia and Apoquel, providing scientific backing for Zenrelia's efficacy [2][8] - Veterinarians have reported positive outcomes in their patients after using Zenrelia, indicating its acceptance in the veterinary community [10]

Six-in-One Parasite Protection in One Chewable Tablet Six of Six Potential Blockbusters from Elanco Now In-Market GREENFIELD, Ind., Jan. 23, 2025 /PRNewswire/ -- Elanco Animal Health Incorporated (NYSE: ELAN) today announced Credelio Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) is now available for veterinarians to order at CredelioQuattroVet.com. With four established and powerful ingredients, Credelio Quattro is designed to deliver the broadest i parasite protection of it ...

I have been investing in common stocks for over 50 years. With all the opportunities and information that is available today, it is more exciting than ever. However, due to extreme current valuations of many stocks, it is increasingly a stock pickers game to find names that have not yet been recognized in the market. The foregoing entails a great deal of work and greater risk, but also the potential for outsized returns. The goal of my writing is to find and research relatively unknown companies that have b ...

GREENFIELD, Ind., Dec. 19, 2024 /PRNewswire/ -- Elanco Animal Health Incorporated (NYSE: ELAN) will participate in the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2025. Jeff Simmons, president and CEO, will represent the company and respond to questions from analysts at 3:00 p.m. PST (6:00 PM EST). A live audio webcast will be available in the "Events and Presentations" section of Elanco's investor website. A replay will be available for approximately 30 days. ABOUT ELANCOElanco An ...

NEW YORK, Dec. 04, 2024 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Elanco Animal Health Incorporated (NYSE: ELAN) between November 7, 2023 and June 26, 2024, both dates inclusive (the “Class Period”), of the important December 6, 2024 lead plaintiff deadline. SO WHAT: If you purchased Elanco securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee a ...

Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of Elanco Animal Health Incorporated regarding a class action lawsuit related to misleading statements and omissions concerning the safety and approval timelines of certain products [1][2]. Group 1: Allegations - The complaint alleges that during the class period from November 7, 2023, to June 26, 2024, Elanco made materially false and misleading statements about the safety of Zenrelia, a canine dermatology product [2]. - It is claimed that Elanco was unlikely to meet its previously issued timeline for the U.S. approval and commercial launch of Zenrelia and Credelio Quattro, a parasiticide for dogs [2]. - The allegations suggest that Elanco's business and financial prospects were overstated, leading to materially false public statements [2]. Group 2: Class Action Details - Shareholders who purchased shares of ELAN during the specified class period are encouraged to register for the class action, with a deadline set for December 6, 2024 [3]. - Once registered, shareholders will receive updates through a portfolio monitoring software regarding the status of the case [3]. - There is no cost or obligation for shareholders to participate in the case [3]. Group 3: Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting the rights of investors affected by deceit and illegal business practices [4]. - The firm aims to ensure companies adhere to responsible business practices and seeks recovery for investors who suffered losses due to misleading statements [4].

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 ...

Core Viewpoint - A lawsuit has been filed against Elanco Animal Health Incorporated and certain senior executives for potential violations of federal securities laws, particularly concerning the FDA approval of key drug treatments [1][2]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court of Maryland, captioned Barpar v. Elanco Animal Health Incorporated, et al., No. 24-cv-02912 [2]. - Investors have until December 6, 2024, to request to be appointed to lead the case [2]. Group 2: Product Development and FDA Review - Elanco is developing two significant treatments: Zenrelia for dermatitis in dogs and Credelio Quattro, an oral parasiticide for fleas, ticks, and internal parasites [3]. - The company previously stated that the FDA had all necessary data for review and expected approvals by the end of June 2024 [4]. Group 3: Stock Price Impact - Following the announcement that the FDA would not approve the drugs as expected, Elanco's stock price fell over 21%, from $17.97 per share on June 26, 2024, to $14.27 per share on June 27, 2024 [5]. - The lawsuit investigates whether Elanco and its executives made materially false or misleading statements regarding the FDA's approval process [5]. Group 4: Legal Representation - Investors in Elanco may have legal options and are encouraged to submit their information to the law firm handling the case, with representation on a contingency fee basis [6]. - The firm has a strong track record in securities class actions and has recovered significant amounts for other clients [7].