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Jaguar Health, Inc. (NASDAQ: JAGX) is a commercial-stage pharmaceuticals company specializing in the development of novel prescription medicines sustainably derived from natural plant sources in rainforest areas. The company's primary focus is on addressing gastrointestinal (GI) distress in both humans and animals, with an emphasis on chronic debilitating diarrhea and associated symptoms such as urgency, bowel incontinence, and cramping pain.
Jaguar Health operates through several subsidiaries, including Napo Pharmaceuticals, Inc., which develops and commercializes proprietary human GI pharmaceuticals globally. One of its flagship products, Mytesi® (crofelemer), is FDA-approved for symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. The company’s lead animal prescription drug candidate, Canalevia™, targets forms of diarrhea in dogs, while Equilevia™ supports total gut health in equine athletes.
In addition, Jaguar Health, through its Napo Pharmaceuticals subsidiary, is advancing the development of crofelemer with the ongoing OnTarget study, a pivotal Phase 3 clinical trial aimed at the preventive treatment of chemotherapy-induced overactive bowel (CIOB) in adults with cancer on targeted therapy. Crofelemer has also been designated an Orphan Drug by the FDA and European Medicines Agency for short bowel syndrome (SBS) and microvillus inclusion disease (MVID).
Jaguar Health’s commitment to cancer supportive care is showcased through its preparation to launch Gelclair®, an FDA-approved oral mucositis prescription product, in Q3 2024. This initiative is part of their broader strategy to support cancer patients facing severe treatment side effects.
Beyond GI distress, Jaguar Health has a joint venture called Magdalena Biosciences, in collaboration with Filament Health Corp. This venture focuses on developing plant-based prescription medicines for mental health indications. A recent out-licensing agreement with Magdalena includes a botanical drug candidate for potential schizophrenia and psychoses indications.
Jaguar Health’s financial performance reflects consistent growth, with Q1 2024 revenue at approximately $2.4 million, showing a 20% increase from Q1 2023. Despite operational losses, the company continues to invest in research and development, particularly for rare disease treatments.
For more information, visit Jaguar Health, Napo Pharmaceuticals, Napo Therapeutics, and Magdalena Biosciences. Stay connected with Jaguar Health on LinkedIn, X (formerly Twitter), and Instagram.
Jaguar Health (NASDAQ:JAGX) announces a dinner event for U.S. veterinary oncologists on April 12, 2022, in Puerto Vallarta, Mexico, coinciding with the Veterinary Cancer Society (VCS) Mid-Year Conference. The dinner will focus on chemotherapy-induced diarrhea (CID) treatment in dogs, featuring a private chef and entertainment. Canalevia-CA1 (crofelemer), the first FDA conditionally approved treatment for CID in dogs, will be showcased at the conference. The VCS Mid-Year Conference runs from April 9-12, 2022, at the Marriott Puerto Vallarta Resort & Spa.
Jaguar Health, Inc. has appointed Pravin Chaturvedi, PhD, as Chief Scientific Officer and Chair of the Scientific Advisory Board. Dr. Chaturvedi, with over 30 years in the pharmaceutical industry, will lead two key crofelemer pipeline development activities over the next 12-15 months. These include the Phase 3 OnTarget trial for cancer therapy-related diarrhea and collaborations for rare diseases like short bowel syndrome. Both initiatives aim to expand patient access and enhance Jaguar's market position, with completion expected soon.
Jaguar Health has entered a strategic agreement with Quadri Pharmaceuticals Store granting exclusive promotional, commercialization, and distribution rights for crofelemer in multiple Middle Eastern countries, including Saudi Arabia and the UAE. This agreement covers human indications approved in the U.S., specifically targeting HIV-related and cancer therapy-related diarrhea. The partnership aims to enhance access to crofelemer, which is currently undergoing a pivotal Phase 3 clinical trial. This initiative is crucial due to the rising HIV statistics in the region, highlighting the growing demand for effective treatments.
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.
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