Welcome to our dedicated page for Jaguar Health news (Ticker: JAGX), a resource for investors and traders seeking the latest updates and insights on Jaguar Health stock.
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 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.
Jaguar Health (NASDAQ:JAGX) announced a rescheduled investor webcast for reviewing Q3 2021 financials on November 17, 2021, at 8:30 AM ET. The change is due to additional time required for finalizing accounting aspects of the recent merger with Dragon SPAC S.p.A. and Napo EU S.p.A.
Jaguar focuses on developing plant-based medicines for GI distress, particularly targeting chronic diarrhea. Its product Mytesi is FDA-approved for relieving noninfectious diarrhea in HIV/AIDS patients on antiretroviral therapy.
Jaguar Health (NASDAQ:JAGX) will host a webcast on November 15, 2021, at 8:30 AM ET to discuss its Q3 2021 financials and provide business updates. Registration is available here. The company focuses on developing plant-based, non-opioid medications for gastrointestinal issues, including its approved product Mytesi (crofelemer), which treats noninfectious diarrhea in adults with HIV/AIDS. For further details, visit jaguar.health.
Jaguar Health, Inc. (NASDAQ:JAGX) announced the appointment of Annabella Amatulli as chief regulatory officer for its Italian subsidiary, Napo EU S.p.A. Amatulli is recognized for her expertise in global regulatory affairs, having previously worked at Dompé and Janssen Pharmaceuticals. She will focus on strategic planning for Napo EU's development programs, particularly for crofelemer, aimed at addressing unmet gastrointestinal medical needs in Europe. The company aims to expedite the drug’s marketing authorization for short bowel syndrome with intestinal failure.
Jaguar Health (NASDAQ:JAGX) has filed a New Animal Drug Application (NADA) to obtain conditional FDA approval for Canalevia™-CA1, an oral, plant-based drug for treating chemotherapy-induced diarrhea (CID) in dogs. The application has been deemed complete, and commercialization is expected by late December 2021. With approximately 6 million new cancer diagnoses in dogs annually, this product addresses a significant need, as there are currently no FDA-approved treatments for CID in dogs. Additionally, Jaguar plans to seek approval for exercise-induced diarrhea (EID) treatment in 2022.
Jaguar Health announced the completion of its merger with Dragon SPAC, officially forming Napo EU S.p.A.
The merger received necessary governmental approvals, as confirmed by CEO Lisa Conte. The new entity will focus on expanding the market for Mytesi (crofelemer) in Europe, a plant-based treatment for noninfectious diarrhea, especially among patients with HIV/AIDS.
This merger aims to bolster Jaguar's presence in the European market, enhancing access to its innovative gastrointestinal pharmaceuticals.
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