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Zoetis Gains CVMP Backing for Lenivia, Eyes EU Approval in Dog OA Pain
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Key Takeaways
Zoetis gained CVMP support for Lenivia, a monoclonal antibody for canine OA pain relief.
Lenivia offers up to 3 months of pain relief with one jab and was well-tolerated in clinical studies.
Lenivia will complement Librela, giving vets and owners both monthly and quarterly OA pain therapy options.
Zoetis (ZTS - Free Report) announced that the European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) has issued a positive opinion for its investigational monoclonal antibody (mAb) therapy, Lenivia (izenivetmab). The recommendation supports granting marketing authorization for the candidate, which has been developed to help relieve pain associated with osteoarthritis (OA) in dogs.
Based on the CVMP’s recommendation, Zoetis expects the European regulatory body to communicate a final decision during the fourth quarter of 2025. Subject to a favorable outcome, the company anticipates making Lenivia commercially available in the EU in 2026.
What an EU Nod for Lenivia Will Mean for ZTS?
If it secures an EU approval, Zoetis’ Lenivia would represent a new antibody-based treatment designed to relieve OA pain in dogs for up to three months with a single injection. The therapy targets nerve growth factor (NGF), a key mediator of pain and inflammation, through its novel binding mechanism. Backed by more than a decade of research, Lenivia has demonstrated a favorable safety profile in a nine-month field study, where treated dogs showed improved mobility and reduced pain following a single dose.
ZTS shares have lost 13.4% year to date against the industry’s 6.8% growth.
Image Source: Zacks Investment Research
For Zoetis, the potential approval of Lenivia not only reinforces its leadership in the animal health sector but also expands its innovative portfolio in companion animal therapeutics. By offering veterinarians and pet owners a novel, convenient option for managing OA pain in dogs, the company stands to strengthen its market presence in the EU and beyond, thereby boosting its revenue stream.
OA is a prevalent, chronic and progressive joint disorder marked by inflammation and cartilage degradation, leading to pain and reduced mobility. While there is no cure, effective management can significantly alleviate pain and enhance quality of life. It is estimated that OA-related pain affects nearly 40% of dogs across all ages and breeds, with chronic pain often impairing movement, sleep, behavior and social interactions.
ZTS’ Lenivia Set to Complement Librela for OA Pain in Dogs
Zoetis’ latest candidate, Lenivia, is poised to expand its OA pain management portfolio for dogs, joining Librela (bedinvetmab), also a mAb therapy that targets NGF, upon approval. While Librela offers monthly pain relief, Lenivia (if approved) would provide a long-acting alternative with dosing required only once every three months. This dual offering would allow veterinarians and dog owners to choose between monthly and quarterly treatment schedules, broadening ZTS’ reach in the canine OA market and reinforcing its leadership in veterinary pain management.
We remind the investors that, last month, Zoetis received a positive opinion from the European Medicines Agency’s CVMP recommending approval of Portela (relfovetmab), its investigational mAb therapy for managing OA pain in cats. Like Lenivia, Portela is also designed to provide up to three months of pain relief with a single injection. A final EU decision is expected in late 2025, with potential launch in 2026. If approved, Portela would become the first long-acting anti-NGF therapy for feline OA pain and complement Zoetis’ existing monthly OA treatment, Solensia (frunevetmab).
With Librela and Solensia already demonstrating clinical and real-world success, the addition of Lenivia and Portela could deepen Zoetis’ penetration into the growing canine/feline OA segment, while also improving treatment adherence due to its less frequent dosing schedule.
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ADC Therapeutics’ earnings beat estimates in two of the trailing four quarters while missing the same on the other two occasions, the average negative surprise being 8.29%.
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Allogene Therapeutics’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with an average surprise of 14.03%.
In the past 60 days, estimates for Chemomab Therapeutics’ 2025 loss per share have narrowed from $2.40 to 60 cents. Loss per share estimates for 2026 have narrowed from $2.80 to $1.00 during the same period. CMMB stock has plunged 54.7% year to date.
Chemomab Therapeutics’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with an average surprise of 26.25%.
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Zoetis Gains CVMP Backing for Lenivia, Eyes EU Approval in Dog OA Pain
Key Takeaways
Zoetis (ZTS - Free Report) announced that the European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) has issued a positive opinion for its investigational monoclonal antibody (mAb) therapy, Lenivia (izenivetmab). The recommendation supports granting marketing authorization for the candidate, which has been developed to help relieve pain associated with osteoarthritis (OA) in dogs.
Based on the CVMP’s recommendation, Zoetis expects the European regulatory body to communicate a final decision during the fourth quarter of 2025. Subject to a favorable outcome, the company anticipates making Lenivia commercially available in the EU in 2026.
What an EU Nod for Lenivia Will Mean for ZTS?
If it secures an EU approval, Zoetis’ Lenivia would represent a new antibody-based treatment designed to relieve OA pain in dogs for up to three months with a single injection. The therapy targets nerve growth factor (NGF), a key mediator of pain and inflammation, through its novel binding mechanism. Backed by more than a decade of research, Lenivia has demonstrated a favorable safety profile in a nine-month field study, where treated dogs showed improved mobility and reduced pain following a single dose.
ZTS shares have lost 13.4% year to date against the industry’s 6.8% growth.
Image Source: Zacks Investment Research
For Zoetis, the potential approval of Lenivia not only reinforces its leadership in the animal health sector but also expands its innovative portfolio in companion animal therapeutics. By offering veterinarians and pet owners a novel, convenient option for managing OA pain in dogs, the company stands to strengthen its market presence in the EU and beyond, thereby boosting its revenue stream.
OA is a prevalent, chronic and progressive joint disorder marked by inflammation and cartilage degradation, leading to pain and reduced mobility. While there is no cure, effective management can significantly alleviate pain and enhance quality of life. It is estimated that OA-related pain affects nearly 40% of dogs across all ages and breeds, with chronic pain often impairing movement, sleep, behavior and social interactions.
ZTS’ Lenivia Set to Complement Librela for OA Pain in Dogs
Zoetis’ latest candidate, Lenivia, is poised to expand its OA pain management portfolio for dogs, joining Librela (bedinvetmab), also a mAb therapy that targets NGF, upon approval. While Librela offers monthly pain relief, Lenivia (if approved) would provide a long-acting alternative with dosing required only once every three months. This dual offering would allow veterinarians and dog owners to choose between monthly and quarterly treatment schedules, broadening ZTS’ reach in the canine OA market and reinforcing its leadership in veterinary pain management.
We remind the investors that, last month, Zoetis received a positive opinion from the European Medicines Agency’s CVMP recommending approval of Portela (relfovetmab), its investigational mAb therapy for managing OA pain in cats. Like Lenivia, Portela is also designed to provide up to three months of pain relief with a single injection. A final EU decision is expected in late 2025, with potential launch in 2026. If approved, Portela would become the first long-acting anti-NGF therapy for feline OA pain and complement Zoetis’ existing monthly OA treatment, Solensia (frunevetmab).
With Librela and Solensia already demonstrating clinical and real-world success, the addition of Lenivia and Portela could deepen Zoetis’ penetration into the growing canine/feline OA segment, while also improving treatment adherence due to its less frequent dosing schedule.
Zoetis Inc. Price and Consensus
Zoetis Inc. price-consensus-chart | Zoetis Inc. Quote
ZTS’ Zacks Rank & Stocks to Consider
Zoetis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ADC Therapeutics (ADCT - Free Report) , Allogene Therapeutics (ALLO - Free Report) and Chemomab Therapeutics (CMMB - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for ADC Therapeutics’ 2025 loss per share have narrowed from $1.77 to $1.68. However, loss per share estimates for 2026 have widened from $1.62 to $1.97 during the same period. ADCT stock has surged 122.1% year to date.
ADC Therapeutics’ earnings beat estimates in two of the trailing four quarters while missing the same on the other two occasions, the average negative surprise being 8.29%.
In the past 60 days, estimates for Allogene Therapeutics’ 2025 loss per share have narrowed from $1.02 to 96 cents. Loss per share estimates for 2026 have narrowed from 98 cents to 86 cents during the same period. ALLO stock has lost 42.3% year to date.
Allogene Therapeutics’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with an average surprise of 14.03%.
In the past 60 days, estimates for Chemomab Therapeutics’ 2025 loss per share have narrowed from $2.40 to 60 cents. Loss per share estimates for 2026 have narrowed from $2.80 to $1.00 during the same period. CMMB stock has plunged 54.7% year to date.
Chemomab Therapeutics’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with an average surprise of 26.25%.