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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) 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.
Jaguar Health (NASDAQ:JAGX) has received conditional approval from the FDA for Canalevia-CA1, the first oral plant-based treatment for chemotherapy-induced diarrhea (CID) in dogs. This product, derived from the Croton lechleri tree, addresses a significant need as CID affects many dogs undergoing cancer treatment. Approximately 1 in 4 dogs may develop cancer, with many experiencing CID as a side effect. Jaguar plans to reveal more commercialization details in January 2022, filling a critical gap in canine cancer care.
Jaguar Health (JAGX) announced that the European Commission has granted Orphan Drug Designation to crofelemer for treating short bowel syndrome (SBS). This milestone follows the application submitted by Napo EU, Jaguar's Italian subsidiary. SBS affects 10,000 to 20,000 individuals in the U.S. and Europe. The global SBS market was valued at over $568 million in 2019 and is projected to reach $4.6 billion by 2027. Napo EU plans to initiate a pivotal clinical trial aiming for accelerated marketing authorization in Europe for crofelemer, which has received similar designation in the U.S.
Jaguar Health has presented findings from the HALT-D trial, evaluating the efficacy of crofelemer for preventing chemotherapy-induced diarrhea (CID) in HER2-positive breast cancer patients. The study involved 51 patients treated with crofelemer or standard care. While the primary endpoint showed no statistical difference in diarrhea incidence, significant improvements were noted in several secondary endpoints, including lower CID occurrence in the crofelemer group (23%). These results provide proof-of-concept data and underscore the need for effective prophylactic treatments for CID during chemotherapy.
Jaguar Health (NASDAQ:JAGX) is set to host a closed satellite event on December 9, 2021, at the San Antonio Breast Cancer Symposium (SABCS) to discuss cancer therapy-related diarrhea. The event will feature oncologists and a presentation on the ongoing OnTarget Pivotal Phase 3 trial of crofelemer, aimed at preventing diarrhea in adult cancer patients receiving targeted therapies. Data from the HALT-D trial will also be presented, evaluating crofelemer for chemotherapy-induced diarrhea in HER2-positive breast cancer patients.
Jaguar Health, Inc. (NASDAQ:JAGX) announced topline results from the Phase 2 HALT-D trial for crofelemer in preventing chemotherapy-induced diarrhea (CID) in HER2-positive breast cancer patients. The trial, involving 51 patients, saw an overall incidence of diarrhea around 70%, showing no significant difference between crofelemer and control groups. However, secondary endpoints indicated crofelemer led to a lower incidence of grade 2 or higher diarrhea compared to standard care. These results support further testing and endpoint selection for the ongoing Phase 3 OnTarget trial.
Jaguar Health reported a 7.6% increase in Mytesi prescription volume in Q3 2021, with net sales around $0.6 million. Despite a decrease in gross revenue to $3.2 million, the company is transitioning to a closed specialty pharmacy network to improve patient access. Upcoming milestones include the presentation of Phase 2 HALT-D study results and the launch of Canalevia-CA1 for dogs. The company reported a net loss of $12.2 million for Q3 2021, a significant increase from $7.9 million in Q3 2020.
Jaguar Health, Inc. (NASDAQ:JAGX) has appointed Massimo Mineo as General Manager of its Italian subsidiary, Napo EU. With over 20 years of pharmaceutical experience, Mineo will spearhead strategies for the marketing authorization of crofelemer, targeting short bowel syndrome with intestinal failure, a rare disease. His prior roles included leading commercial operations at Recordati Rare Diseases, where he successfully launched orphan drugs. The appointment is expected to strengthen Napo EU's market presence in Europe, enhancing access to crofelemer for patients in need.
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