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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.
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.
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.
Jaguar Health will implement a 1-for-60 reverse stock split of its common stock on May 23, 2024, following approval at the April 2024 Special Meeting of Stockholders. The split aims to support compliance with Nasdaq listing standards and attract institutional investors. Post-split, the stock will trade under the symbol JAGX with a new CUSIP number: 47010C805. Fractional shares will be settled in cash.
Equiniti Trust Company will handle the exchange process for stockholders holding certificates. No action is required for those with shares in brokerage accounts.
Jaguar Health (NASDAQ:JAGX) reported a 20% increase in net revenue for Q1 2024, amounting to $2.4 million compared to $2.0 million in Q1 2023, and a 4% increase from Q4 2023. The company is set to release top-line results from its Phase 3 OnTarget trial for crofelemer, aimed at treating cancer therapy-related diarrhea. A commercial launch for the FDA-approved oral mucositis product Gelclair is planned for Q3 2024. Despite a reduction in Mytesi prescription volumes, the company achieved a net loss reduction of 24%, equating to $9.2 million, compared to $12.2 million in Q1 2023. Operational loss decreased by 17%, from $9.8 million to $8.2 million, due to reductions in R&D, sales, marketing, and administrative expenses. However, the overall cost of product revenue increased slightly.
Jaguar Health, Inc. (NASDAQ: JAGX) will hold an investor webcast on May 14, 2024, to discuss Q1 2024 financials and corporate updates.
Jaguar Health announced the submission of Clinical Trial Applications for Crofelemer for the rare disease indications Microvillus Inclusion Disease (MVID) and Short Bowel Syndrome (SBS) in Europe. The novel plant-based prescription drug Crofelemer has been granted Orphan Drug Designation by the FDA and the European Medicines Agency for both MVID and SBS. Clinical Trial Applications have been submitted to Italian and German health authorities for a phase 2 clinical trial for the treatment of SBS in adults and to AIFA in Italy for a trial in pediatric patients with MVID. The company aims to develop a novel powder formulation of Crofelemer for oral solution to help patients with these devastating rare diseases. Proof-of-concept results are expected in 2024 in the US, EU, and MENA regions.
Jaguar Health, Inc. (NASDAQ: JAGX) will hold an investor webcast on May 14, 2024, to discuss Q1 2024 financials and corporate updates. The company plans to file its Earnings Report on Form 10-Q for the quarter ended March 31, 2024.
Jaguar Health's prescription drug crofelemer, approved by the FDA for chemotherapy-induced diarrhea in dogs, is now being investigated for the treatment of general diarrhea in dogs. The company aims to address the unmet need for FDA-approved anti-secretory agents for canine diarrhea.
Jaguar Health, Inc. announced that its subsidiary Napo Pharmaceuticals is sponsoring a Pediatric Gastroenterology Conference in Abu Dhabi and a panel discussion on Microvillus Inclusion Disease. The company's drug crofelemer has Orphan Drug Designation for MVID and short bowel syndrome (SBS). Proof-of-concept studies for these diseases are planned for 2024. The FDA activated Napo's IND application for a phase 2 trial of crofelemer for pediatric MVID patients, with results expected in 2024. MVID is a severe infantile disease with no approved treatments. Leading experts in MVID treatment will participate in the panel discussion.
