Jaguar Health Inc Stock Price, News & Analysis

Jaguar Health (NASDAQ:JAGX) announced progress in its field study of Canalevia-CA1, an FDA conditionally approved prescription drug for treating chemotherapy-induced diarrhea (CID) in dogs. The company has enrolled four dogs across six veterinary oncology clinics, with more clinics potentially joining.

Jaguar is actively seeking partnerships to achieve three key objectives for Canalevia: obtain EU approval for general diarrhea treatment based on existing study data, maintain U.S. availability for CID treatment, and expand U.S. indication to include general diarrhea. The company plans to submit documentation to the European Medicines Agency (EMA) highlighting updated analysis of their completed study, potentially leading to approval across all 27 EU member countries.

The market opportunity is significant, with 104 million dogs in Europe and approximately 6 million annual cases of acute and chronic diarrhea seen by U.S. veterinarians. The drug, derived from the Croton lechleri tree, is currently available through major U.S. veterinary distributors, including Chewy.

Jaguar Health (NASDAQ:JAGX) announced that Peru's National Institute of Agrarian Innovation (INIA) has authorized an access and benefit sharing agreement for coca plant research. The agreement, signed with Psilo Scientific (a Filament Health subsidiary), supports the research efforts of Magdalena Biosciences, a joint venture between Jaguar Health and Filament Health.

The agreement focuses on two cultivated coca species - Erythroxylum coca and Erythroxylum novogranatense - and includes an Internationally Recognized Certificate of Compliance (IRCC) under the Convention on Biological Diversity. The research aims to develop novel, natural prescription medicines from coca leaves for mental health and CNS indications under FDA Botanical Guidance.

Jaguar Health (NASDAQ:JAGX) announced positive proof-of-concept results for their drug crofelemer in treating a third intestinal failure patient. The novel liquid formulation demonstrated efficacy in reducing total parenteral nutrition (TPN) requirements in a second pediatric patient with short bowel syndrome (SBS-IF).

The results build on previously reported data showing crofelemer reduced TPN requirements by up to 27% in microvillus inclusion disease (MVID) patients and up to 12.5% in SBS-IF patients. Notably, when the first two patients were taken off crofelemer after 12 weeks of treatment, their symptoms worsened, leading to prompt reinstatement of the treatment.

The company is conducting multiple studies, including two independent proof-of-concept investigator-initiated trials (IITs) and two placebo-controlled Phase 2 studies. The Phase 2 study in pediatric MVID patients is expected to complete by mid-2026. Jaguar is actively seeking business development partnerships for licensing rights to develop and commercialize their intestinal failure products, aiming to generate non-dilutive funding.

[ "Crofelemer reduced TPN requirements by up to 27% in MVID patients and 12.5% in SBS-IF patients", "Second pediatric SBS-IF patient showed similar positive response for TPN reduction", "No safety issues reported at highest protocol-approved dose", "Results may support inclusion in EMA's PRIME program and FDA's Breakthrough Therapy program", "Data could support reimbursed early patient access in EU countries" ]

Jaguar Health (NASDAQ:JAGX) announced that its Board of Directors has unanimously authorized the inclusion of cryptocurrency as a treasury reserve asset. The company views this as a strategic move to diversify its treasury holdings with digital assets that offer potential upside and inflation protection.

CEO Lisa Conte revealed that several banks and an investor have approached Jaguar with cryptocurrency transaction terms. The company is currently evaluating the potential benefits for shareholders and its core development programs. Jaguar continues to focus on developing crofelemer, its plant-based prescription medicine, across three main programs: intestinal failure, cancer therapy-related diarrhea treatment, and expanding Canalevia® for dogs.

Jaguar Health (NASDAQ:JAGX) announced plans to pursue European Medicines Agency approval for Canalevia to treat general diarrhea in dogs in the EU. The drug, which contains plant-based crofelemer, is currently conditionally FDA-approved for chemotherapy-induced diarrhea in dogs under the name Canalevia-CA1.

The company is in discussions with potential animal health partners to achieve three goals: EU approval for general diarrhea treatment, maintaining U.S. availability for chemotherapy-induced diarrhea, and expanding U.S. indication to include general diarrhea. A completed study of 200 dogs showed significant improvement in fecal scores using a revised endpoint analysis. The potential market is substantial, with 104 million dogs in Europe and approximately 6 million annual cases of acute and chronic diarrhea in U.S. veterinary practices.

Jaguar Health (NASDAQ:JAGX) has announced the extension of maturity date for its convertible promissory notes from June 30, 2025 to January 30, 2026. The extension applies to approximately $2.57 million in aggregate principal amount from the original $3.448 million bridge financing that closed on March 31, 2025. Prior to this extension, five investors converted $0.866 million (including accrued interest) into company equity.

The bridge financing participants include the company's CEO, board members, other C-suite executives, and institutional and accredited investors. The funding aims to support Jaguar's three core development programs for crofelemer: orphan disease intestinal failure program, cancer therapy-related diarrhea treatment, and expansion of Canalevia® for dogs.

Jaguar Health (NASDAQ:JAGX) reports progress in its orphan disease intestinal failure program for crofelemer. The Phase 2 study for microvillus inclusion disease (MVID) in pediatric patients has reached 25% enrollment, while the SBS-IF study in adults is above 10%. Initial proof-of-concept results show crofelemer reduced total parenteral nutrition requirements by up to 27% in MVID patients and 12.5% in short bowel syndrome patients. The company expects to complete its randomized Phase 2 MVID study by mid-2026. Jaguar is actively seeking business development partnerships for licensing rights to develop and commercialize its intestinal failure products, aiming to generate non-dilutive funding. The positive early results could potentially support inclusion in EMA's PRIME program and FDA's Breakthrough Therapy program, potentially accelerating regulatory approval pathways.

Jaguar Health (NASDAQ:JAGX) announced that its founder, president and CEO Lisa Conte will deliver a virtual presentation at the Emerging Growth Conference on June 18, 2025, from 9:40 - 10:10 AM Eastern Time. The presentation will be available online, with a replay accessible through EmergingGrowth.com and the Emerging Growth YouTube Channel. This conference presentation aims to provide updates on near-term catalysts for the company.

Jaguar Health (NASDAQ:JAGX) has established the first study site for its field study of Canalevia-CA1, an FDA conditionally approved prescription drug for treating chemotherapy-induced diarrhea (CID) in dogs. The company has two main objectives: obtaining full FDA approval for CID treatment and expanding the drug's indication to treat general, non-infectious diarrhea in dogs. Jaguar is actively seeking partners to fund development and commercialization of the drug for the broader diarrhea indication. The market opportunity is significant, with approximately 6 million annual cases of acute and chronic diarrhea in dogs seen by U.S. veterinarians. The prospective, randomized, open-label field study will collect real-world data on Canalevia-CA1's effectiveness in dogs undergoing chemotherapy. Currently, there are no FDA-approved drugs for treating general diarrhea in dogs, despite it being one of the most common reasons for veterinary visits.