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Jaguar Health, Inc. - JAGX STOCK NEWS

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.

Rhea-AI Summary

Jaguar Health (NASDAQ:JAGX) announced results from its Phase 3 OnTarget trial of crofelemer for prophylaxis of diarrhea in adult cancer patients with solid tumors receiving targeted therapy. The trial did not meet its primary endpoint across all tumor types. However, it revealed clinically relevant signals for crofelemer in prespecified subgroups of patients with breast and respiratory cancer, including lung cancer. These subgroups comprised over 75% of trial participants.

Key takeaways:

  • Trial included 10 tumor types and 24 targeted agents
  • Positive signals improved over the initial 12-week phase
  • Crofelemer was well-tolerated with an adverse event profile similar to placebo
  • Company plans to engage with FDA after full data review

Jaguar will host an investor webcast on July 23, 2024, to provide updates on its cancer supportive care portfolio.

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Jaguar Health (NASDAQ:JAGX) will report results of its Phase 3 OnTarget trial for crofelemer, a cancer supportive care drug, on July 23, 2024. The company will hold an investor webcast at 8:30 AM Eastern to discuss the results and provide updates on its cancer supportive care portfolio. The webcast will feature Jaguar's scientific team, patient advocates, and oncology experts focusing on cancer therapy-related diarrhea (CTD) and oral mucositis.

Jaguar has expanded its 'Make Cancer Less Shitty' (MCLS) patient advocacy program, incorporating MCLS Ambassadors who are cancer survivors. The company also entered a 5-year U.S. in-license agreement for Gelclair, an FDA-approved oral mucositis product. These initiatives aim to address the significant impact of treatment side effects on cancer patients' quality of life and treatment adherence.

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Jaguar Health has announced the issuance of new patents in Europe and Australia to bolster IP protection for its drug crofelemer, aimed at treating Short Bowel Syndrome (SBS) and Congenital Diarrheal Disorders (CDDs). The European patent covers treatment methods for SBS and associated conditions, while the Australian patent focuses on CDDs. The patents enhance Jaguar's intellectual property portfolio, which already includes approximately 200 patents issued or pending. This development supports ongoing proof-of-concept studies of crofelemer in the US, EU, and MENA regions, with results expected in 2024 and 2025. These studies could facilitate early patient access to crofelemer in countries with applicable guidelines. SBS and MVID patients suffer from severe symptoms requiring intensive medical support, highlighting the potential impact of these patents on patient care.

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Jaguar Health (NASDAQ: JAGX) has announced that it has regained compliance with Nasdaq's bid price requirement as of June 25, 2024, ensuring its securities remain listed and traded on Nasdaq. The company is also set to report results from its pivotal phase 3 OnTarget trial for the cancer supportive care drug crofelemer by July 23, 2024. Jaguar's CEO, Lisa Conte, emphasized the importance of maintaining their Nasdaq listing and mentioned an upcoming investor webcast that will discuss Jaguar's cancer supportive care portfolio, featuring insights from scientific experts and patient advocates.

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Jaguar Health announced the approval of all proposals at its Annual Meeting of Stockholders held on June 21, 2024. Five proposals were submitted and approved, details of which are available in the company's proxy statement filed with the SEC. Jaguar will report results from its pivotal phase 3 OnTarget trial for the cancer supportive care drug crofelemer by July 23, 2024. An investor webcast on or before this date will include updates on Jaguar's cancer supportive care portfolio, featuring insights from the scientific team, patient advocates, and oncology experts. In celebration of World Rainforest Day on June 22, Jaguar shared a RealPharma podcast interview with Dr. Steven King, highlighting his ethnobotanical research and the medicinal use of plants by indigenous Amazonian communities.

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Jaguar Health announced it will release the results of its phase 3 OnTarget trial for crofelemer, aimed at preventing diarrhea in cancer patients, by July 23, 2024. The study involves patients with solid tumors undergoing targeted therapy, with or without chemotherapy. An investor webcast will present the trial results and updates on Jaguar's cancer supportive care initiatives. Key points include Jaguar's in-license of Gelclair for oral mucositis, a commercialization deal with GEN for crofelemer in Turkey, and the 'Make Cancer Less Shitty' advocacy program. The company emphasizes the importance of supportive care in improving cancer patients' quality of life.

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Jaguar Health announced a new employee inducement grant under Nasdaq Listing Rule 5635(c)(4), effective June 4, 2024. The company has granted 1,111 restricted stock units (RSUs) to a new employee, which will vest over one year. This grant, approved by Jaguar's Compensation Committee, was made to attract the new hire. The vesting of these RSUs is contingent upon the employee's continued service with Jaguar through the vesting period.

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Jaguar Health has announced an out-licensing agreement with Magdalena Biosciences for a botanical drug candidate aimed at treating schizophrenia. This drug shows antipsychotic activity with a unique mechanism of action compared to current FDA-approved therapies. Under the deal, Jaguar will receive 10% of all upfront and milestone payments, excluding certain commercial milestones and R&D reimbursements. Additionally, Jaguar will earn royalties on net sales if the drug is FDA-approved and commercialized. The U.S. schizophrenia market is forecasted to reach $8.06 billion by 2030. Jaguar will present at the Lytham Partners Spring 2024 Investor Conference on May 30.

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Jaguar Health announced that a third-party, investigator-initiated study of its plant-based drug, crofelemer, showed positive results for treating functional diarrhea. The study revealed that twice-daily oral doses of crofelemer significantly reduced abdominal pain and improved stool consistency compared to a placebo. Functional diarrhea, a chronic condition affecting 4.7% of adults globally, currently lacks effective treatments. Napo Pharmaceuticals, a subsidiary of Jaguar, is planning to submit an abstract of the study to a peer-reviewed journal. Crofelemer is derived from the red bark sap of the Croton lechleri tree, harvested sustainably in the Amazon Rainforest.

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Jaguar Health (NASDAQ: JAGX) is expanding its commercial footprint in cancer supportive care. The company will showcase Gelclair, an FDA-approved product for oral mucositis, at the ASCO Annual Meeting from May 31 to June 4. Gelclair, which Jaguar licensed for the U.S. market, is set for commercial launch in Q3 2024. Oral mucositis, a painful side effect of cancer treatment, affects up to 90% of head and neck cancer patients. Jaguar is also nearing top-line results for its phase 3 OnTarget trial of crofelemer to prevent cancer therapy-related diarrhea.

With 18 million Americans living with a cancer diagnosis, and over 2 million new cases expected in 2024, Jaguar's focus on improving cancer patient quality of life is significant. The company emphasizes Gelclair's ability to manage pain without numbing or stinging, potentially reducing hospitalizations and treatment interruptions. The economic impact of oral mucositis is considerable, with costs exceeding $17,000 for head and neck cancer patients.

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FAQ

What is Jaguar Health, Inc.?

Jaguar Health, Inc. is a commercial-stage pharmaceuticals company developing novel, plant-based prescription medicines for gastrointestinal distress in humans and animals.

What are the main products of Jaguar Health?

Jaguar Health's main products include Mytesi® for noninfectious diarrhea in adults with HIV/AIDS, Canalevia™ for treating diarrhea in dogs, and Equilevia™ for equine gut health. They are also developing Gelclair® for oral mucositis.

What is Mytesi® used for?

Mytesi® (crofelemer) is an antidiarrheal medication approved by the FDA for symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.

What is the OnTarget study?

The OnTarget study is a Phase 3 clinical trial evaluating the effectiveness of crofelemer in preventing chemotherapy-induced overactive bowel (CIOB) in adults undergoing cancer therapy.

What recent achievements has Jaguar Health made?

Recent achievements include the approval of crofelemer as an Orphan Drug for SBS and MVID, initiation of phase 2 clinical trials in Europe, and preparation for the commercial launch of Gelclair®.

What is the focus of Magdalena Biosciences?

Magdalena Biosciences, a joint venture with Filament Health Corp., focuses on developing novel plant-based prescription medicines for mental health indications, including a botanical drug candidate for schizophrenia.

What are the financial highlights for Jaguar Health in Q1 2024?

In Q1 2024, Jaguar Health reported a combined net revenue of approximately $2.4 million, a 20% increase compared to Q1 2023. The company continues to invest in R&D, particularly for rare disease treatments.

What sustainability practices does Jaguar Health follow?

Jaguar Health employs sustainable harvesting practices under fair trade guidelines for the plant-based ingredients used in their products, ensuring high quality and ecological integrity.

How can I stay updated on Jaguar Health's developments?

You can stay updated by visiting Jaguar Health's official website, and following them on LinkedIn, X (formerly Twitter), and Instagram.

What is Gelclair® and its use?

Gelclair® is an FDA-approved prescription product used for managing and relieving pain associated with oral mucositis, a common side effect of cancer treatments.

Jaguar Health, Inc.

Nasdaq:JAGX

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Pharmaceutical Preparation Manufacturing
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