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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) announced the first patient dosing in an investigator-initiated proof-of-concept (POC) trial evaluating crofelemer for Microvillus Inclusion Disease (MVID) at Sheikh Khalifa Medical City in UAE. The trial, led by Dr. Mohamad Miqdady, will also include pediatric patients with short bowel syndrome with intestinal failure (SBS-IF).
This study is one of five clinical efforts for crofelemer in rare diseases, with POC data potentially available in H1 2025. Positive results could lead to reimbursed early patient access in certain European countries. Crofelemer has received Orphan Drug Designation from both FDA and European Medicines Agency for MVID and SBS-IF.
MVID affects a few hundred patients globally, while SBS affects 10,000-20,000 people in both the U.S. and Europe. Pediatric SBS incidence varies between 0.02% to 1.2% of live births, with a maximal U.S. incidence estimated at approximately 43,000 based on 2023 birth rates.
Jaguar Health (NASDAQ:JAGX) has announced the granting of restricted stock units (RSUs) to three new employees, effective January 8, 2025. The company issued 15,000 RSUs each to two employees and 45,000 RSUs to a third employee. For the first two employees, the RSUs will vest over one year from their respective hire dates, while the third employee's RSUs will vest equally over three years, with one-third vesting annually. These grants were approved by Jaguar's Compensation Committee as inducement material for employment acceptance and require continued service with the company through applicable vesting dates.
Jaguar Health (NASDAQ:JAGX) has announced two upcoming investor presentations. CEO Lisa Conte will participate in a virtual fireside chat at the Lytham Partners 2025 Investor Healthcare Summit on January 13, 2025, at 12:00 PM EST, with replay available. Additionally, the company will deliver an in-person presentation at the Biotech Showcase on January 14, 2025, at 3:00 PM PST at the Hilton San Francisco - Union Square in the Yosemite A track.
Magdalena Biosciences, a joint venture between Jaguar Health (NASDAQ:JAGX) and Filament Health, plans to present at the Annual Neuroscience Innovation Forum on January 12, 2025. The company is preparing to submit an Investigational New Drug (IND) application in early 2025 for their lead candidate MB2500, targeting mental health conditions including ADHD and schizophrenia.
MB2500 is particularly noteworthy as it could potentially become the first treatment for cognitive deficit in schizophrenia, addressing a significant unmet medical need. The drug is derived from a historically used plant with proven neuroprotective and cognitive enhancing properties. Magdalena's innovative approach aims to accelerate development from plant extract to proof-of-concept studies within 12-24 months.
The company targets the $25 billion global ADHD market and the schizophrenia market, projected to reach $13.41 billion by 2032. Magdalena, approximately 40% owned by Jaguar Health, plans to submit 1-2 additional IND applications in 2025 for other mental health indications including anxiety and depression.
Jaguar Health (NASDAQ:JAGX) announced that its joint venture, Magdalena Biosciences, has successfully imported 6 kilograms of coca leaf from Peru to Filament's Vancouver facility. The import, authorized by Peru's Health Authority DIGEMID and sourced from ENACO, marks Magdalena's second coca leaf import into Canada.
The initiative aims to develop novel plant-based prescription medicines for mental health conditions, particularly exploring coca leaf's therapeutic potential for ADHD and other neuropsychiatric indications. Dr. Steven King, Jaguar's Chief Sustainable Supply Officer, will present on coca-based Botanical Drugs at the Wisdom of the Leaf Coca Summit in February 2025.
Magdalena's mission focuses on developing FDA-approved plant-based drugs for conditions including schizophrenia, anxiety, depression, and ADHD, emphasizing potentially safer alternatives to traditional medications that may have side effects.
Jaguar Health (NASDAQ:JAGX) has initiated a Phase 2 study to evaluate crofelemer, its plant-based prescription drug, for Microvillus Inclusion Disease (MVID) in pediatric patients. This study is part of five clinical efforts, including three proof-of-concept trials and two Phase 2 studies, across US, EU, and MENA regions. The first patient dosing is expected between December 2024 and January 2025, with initial results potentially available in Q1 2025.
Crofelemer has received Orphan-Drug Designation from both FDA and EMA for MVID and SBS-IF. The study will evaluate a novel oral powder solution formulation, different from the FDA-approved Mytesi® tablets. MVID is an ultrarare pediatric disease affecting approximately 200 patients globally, characterized by severe diarrhea and malabsorption, with no currently approved treatments.
Jaguar Health (NASDAQ:JAGX) announced that the FDA has granted orphan-drug designation (ODD) to crofelemer for treating diarrhea in cholera patients. This plant-based prescription drug previously received Phase 2 data from clinical trials in Bangladesh. The ODD provides development incentives including tax credits and a seven-year marketing exclusivity period if approved.
Crofelemer is currently involved in five rare disease clinical trials, with patient dosing expected throughout December 2024 and Q1 2025. Results could be available by Q2 2025. The company also plans to pursue ODD for a second-generation agent, NP-300, along with a Tropical Disease Priority Review Voucher, which historically has sold for $67-350 million.
Cholera affects 1.3-4 million cases globally annually, with 21,000-143,000 deaths. WHO has classified the global cholera resurgence as a grade 3 emergency, its highest internal level.
Ladenburg Thalmann is hosting a Scientific Showcase webinar on December 18, 2024, focusing on Jaguar Health's (NASDAQ:JAGX) clinical development of crofelemer, their plant-based anti-diarrheal drug. The event will highlight five ongoing clinical efforts for rare disease indications: three proof-of-concept investigator-initiated trials and two Phase 2 studies targeting microvillus inclusion disease (MVID) and short bowel syndrome with intestinal failure (SBS-IF) across US, EU, and Middle East/North Africa regions. Initial proof-of-concept results are expected in Q2 2025. The company also announced that Massimo Radaelli, CEO of Napo Therapeutics and President of Jaguar International, was named 'Best Pharmaceuticals Innovator of the Year - Europe' by The European publication.
Jaguar Health (NASDAQ:JAGX) announced significant positive results from its Phase 3 OnTarget trial evaluating crofelemer for cancer therapy-related diarrhea (CTD) in breast cancer patients. The trial included 183 breast cancer patients out of 287 total participants. 47.1% of patients receiving crofelemer were responders through 12 weeks, compared to 33.7% in the placebo group, showing statistically significant improvement in diarrhea control.
The study revealed that among breast cancer patients on abemaciclib, over 43% required dose reduction or termination due to diarrhea, while all patients on pertuzumab-based therapies needed dose adjustments. Napo Pharmaceuticals plans to submit these results to the FDA to discuss pathways for making crofelemer available to breast cancer patients.
Jaguar Health (NASDAQ:JAGX) announced that data from their Phase 3 OnTarget trial's breast cancer subgroup analysis will be presented at the San Antonio Breast Cancer Symposium (SABCS) on December 11, 2024. The presentation will highlight significant results of crofelemer for Cancer Therapy-Related Diarrhea (CTD) in breast cancer patients, who formed the majority of trial participants.
While the initial OnTarget study did not meet its primary endpoint across all tumor types, the breast cancer subgroup showed promising outcomes. The company plans to submit these findings to the FDA to discuss potential pathways for making crofelemer available to breast cancer patients. A full study report will be submitted to a peer-reviewed journal.
A second poster presentation focusing on the trial's placebo arm data will also be featured at SABCS, which expects over 10,000 attendees.
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