Jaguar Health Inc Stock Price, News & Analysis

Jaguar Health, Inc. (NASDAQ:JAGX) announced a recorded investor webcast on March 14, 2022, sharing company updates and 2021 financial results. Key initiatives include the ongoing OnTarget Phase 3 clinical trial for crofelemer, focused on preventing cancer therapy-related diarrhea. The company reported Mytesi net revenue of approximately $2.1 million in Q4 2021, a significant increase of 230% from Q3 2021. Additionally, Jaguar received FDA conditional approval in December 2021 for Canalevia™-CA1 treating chemotherapy-induced diarrhea in dogs.

Jaguar Health provided a comprehensive update on its progress during 2021, highlighting critical milestones in the development of its plant-based drug pipeline. Key achievements include the ongoing OnTarget Phase 3 clinical trial for crofelemer, FDA conditional approval for Canalevia-CA1 for chemotherapy-induced diarrhea in dogs, and a significant revenue increase for Mytesi, which saw net revenues of approximately $2.1 million in Q4 2021, marking a 230% increase from Q3 2021. Despite these advances, the company reported a substantial net loss of $52.6 million for 2021.

Jaguar Health (NASDAQ:JAGX) has announced an investor webcast scheduled for March 14, 2022, at 8:30 AM ET to discuss its Q4 2021 financials and corporate updates. The company plans to file its Annual Report on March 11, 2022, for the fiscal year ending December 31, 2021. Jaguar focuses on developing plant-based, non-opioid prescription medicines for gastrointestinal distress. Their crofelemer drug candidate is being evaluated in a pivotal Phase 3 clinical trial. For more information, visit jaguar.health.

Jaguar Health, Inc. (NASDAQ:JAGX) has announced a treatment forum for veterinarians on March 6, 2022, during the Western Veterinary Conference in Las Vegas. The forum will discuss chemotherapy-induced diarrhea (CID) in dogs and feature noted oncologist Dr. Craig A. Clifford. Canalevia-CA1, the first FDA conditionally approved treatment for CID in dogs, will be highlighted. Registration is open to U.S. veterinarians and media via the Canalevia website. The event aims to address the unmet need for effective CID treatments as over half of veterinarians report CID impacting chemotherapy plans.

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.