Jaguar Health Inc Stock Price, News & Analysis

Jaguar Health (NASDAQ:JAGX) has applied for MUMS designation from the FDA for Canalevia™-CA2, aimed at treating exercise-induced diarrhea (EID) in dogs. This follows the conditional approval of Canalevia™-CA1 for chemotherapy-induced diarrhea (CID) in December 2021.

The MUMS designation would provide incentives for drug development, including potential federal grants and seven years of marketing exclusivity following conditional approval. This marks a significant step in expanding treatment options for veterinary care.

Jaguar Health (NASDAQ:JAGX) announced that its Italian subsidiary, Napo Therapeutics, has received Small and Medium Enterprise (SME) designation from the European Medicines Agency (EMA). This status provides financial incentives and support for the regulatory process, crucial for advancing the availability of crofelemer in Europe for treating rare diseases. SME companies have shown a high success rate of 89% for marketing authorizations, with nearly 20% of human medicines recommended for authorization in 2020 targeting rare diseases.

Jaguar Health, Inc. (NASDAQ:JAGX) has completed a major regulatory filing with the FDA for its oral plant-based drug, Canalevia, aimed at treating exercise-induced diarrhea (EID) in dogs. Following earlier conditional approval for chemotherapy-induced diarrhea, this new application may lead to approval by Q4 2022. The MUMS designation may provide financial incentives for this treatment, which is estimated to affect 5,000 to 15,000 dogs annually in the U.S. The submission process completes critical sections initiated in 2020.

Jaguar Health, Inc. (NASDAQ:JAGX) and its subsidiary Napo Pharmaceuticals announced the completion of a preclinical study on crofelemer for congenital diarrheal disorders (CDD). This research aims to support the orphan drug designation (ODD) application filed with the FDA for treating CDD in infants and children. The study results are anticipated to bolster Napo Therapeutics' rare disease business model in Europe. Crofelemer may potentially reduce morbidity related to CDD and lessen the dependence on parenteral nutrition, addressing a significant unmet medical need.

Jaguar Health (NASDAQ:JAGX) has appointed Dr. Martire Particco as Chief Medical Officer of Napo Therapeutics, focusing on expanding access to crofelemer for treating rare diseases in Europe, particularly short bowel syndrome (SBS) and congenital diarrheal disorders (CDD). Dr. Particco, who has over 30 years of experience in the pharmaceutical industry, aims to leverage his expertise in drug development and clinical trials to support the marketing authorization of crofelemer in Europe. Both the European Medicines Agency and the FDA have granted orphan-drug designations for crofelemer.

Jaguar Health announced significant advancements in its human pipeline for chemotherapy-related diarrhea (CTD) and short bowel syndrome with intestinal failure (SBS-IF) in its recent corporate update. The company received conditional approval for Canalevia-CA1 for dogs, which launched in December 2021. In 2022, Jaguar aims to complete a Phase 3 CTD study and one for SBS-IF. The global market for SBS is expected to reach $4.6 billion by 2027, emphasizing the potential for Jaguar's products amid growing cancer treatment needs.

Jaguar Health, Inc. (NASDAQ:JAGX) announced a treatment forum for veterinarians on January 16, 2022, focusing on chemotherapy-induced diarrhea (CID) in dogs. The event will be led by Dr. Craig A. Clifford and will discuss the burden of CID, as well as the efficacy of Canalevia-CA1, the first FDA conditionally approved treatment for CID in dogs. The forum will be held from 6 p.m. to 8 p.m. Eastern at the Veterinary Meeting & Expo (VMX) in Orlando, FL. Remote access will be available for registered attendees unable to attend in person.

Jaguar Health (NASDAQ:JAGX) has launched Canalevia™-CA1, the first FDA-approved treatment for chemotherapy-induced diarrhea (CID) in dogs. The FDA granted conditional approval on December 21, 2021, allowing Jaguar to commercialize the product while collecting further evidence of effectiveness. Canalevia-CA1 is expected to be available from various veterinary distributors in January 2022. The launch addresses the unmet need identified in surveys where over half of veterinarians reported CID as a significant issue impacting treatment compliance in dogs undergoing chemotherapy.

Jaguar Health announced that its product Canalevia-CA1, a canine formulation of crofelemer, has received conditional approval from the FDA for treating chemotherapy-induced diarrhea (CID) in dogs. This marks a significant advancement in mitigating the severe side effects of chemotherapy in canines. The FDA's recognition highlights the importance of extending quality of life during cancer treatments. Canalevia-CA1 is the first oral plant-based prescription specifically approved for this purpose and aims to support dog owners and veterinarians.