Jaguar has received the initial $16M payment related to the company's recently executed US out-license agreement for Mytesi® and Canalevia®-CA1, which has the potential to provide Jaguar up to an additional $22M with milestones and other potential future payments Near-term milestones for intestinal failure program buttressed by groundbreaking results of parenteral support (PS) reduction ranging from 12 to 37% in ongoing proof-of-concept study of crofelemer in pediatric patients Associated with significant t ...

Core Insights - PainReform Ltd. announced a name change and is expanding into diversified healthcare and AI-driven energy platforms, resulting in a 27.4% increase in share price to $1.02 in pre-market trading [1] Gainers - Acco Group Holdings Limited saw a significant gain of 219.4%, reaching $9.40 in pre-market trading [4] - Venus Concept Inc. increased by 72.2% to $2.48 [4] - Jaguar Health, Inc. rose 41.3% to $1.08 following a licensing agreement with Woodward Specialty [4] - ImmunityBio, Inc. gained 22.8% to $4.85, with preliminary net product revenue for Anktiva projected at approximately $113 million for fiscal 2025, marking a 700% year-over-year increase [4] - OneMedNet Corporation rose 14.2% to $0.9711 after a previous decline [4] - Brand Engagement Network, Inc. increased by 13.8% to $6.50 [4] - Springview Holdings Ltd rose 13.4% to $19.75 after a substantial 657% increase on Thursday [4] - Creative Global Technology Holdings Limited gained 10.7% to $4.22 after a 52% jump on Thursday [4] - Kopin Corporation increased by 8.1% to $3.20 [4] Losers - Callan JMB Inc. fell 20.7% to $3.33 after a 275% increase on Thursday due to a strategic agreement with Biostax Corp [4] - Erayak Power Solution Group Inc. decreased by 18.3% to $3.21 after an 18% rise on Thursday [4] - TryHard Holdings Limited dropped 16.4% to $6.35 following a 76% decline on Thursday due to a joint venture announcement [4] - iOThree Limited shares dipped 15% to $2.56 [4] - NOVONIX Limited fell 14% to $1.17 [4] - Moolec Science SA tumbled 13.1% to $6.69 after an 118% increase on Thursday [4] - High Roller Technologies, Inc. declined 12.9% to $20.64 after a 25% rise on Thursday [4] - Bonk, Inc. fell 10.4% to $3.55 after a 42% increase on Thursday due to acquisition news [4] - J B Hunt Transport Services Inc fell 4.2% to $197.86, reporting mixed financial results for the fourth quarter [4] - QXO Inc dipped 3.5% to $24.14 after announcing a $750 million stock offering and preliminary fourth-quarter net sales of $2.19 billion [4]

Summary of Jaguar Health FY Conference Call Company Overview - **Company Name**: Jaguar Health (NasdaqCM: JAGX) - **Subsidiary**: Napo Pharmaceuticals - **Key Product**: Crofelemer (brand name Mytesi), FDA-approved for chronic diarrhea in HIV/AIDS patients and chemotherapy-induced diarrhea in dogs under the brand name Canalevia-CA1 [4][5] Core Points and Arguments - **Product Development**: Jaguar Health focuses on drug development from plants traditionally used in tropical areas, with crofelemer being a first-in-class FDA-approved anti-secretory agent [4][5] - **Exclusivity**: The company holds over 150 patents and has exclusivity due to the FDA's botanical guidance, which prevents generics from entering the market [5] - **Recent Licensing Agreement**: An exclusive license agreement with FuturePak could be worth up to $38 million, including an upfront payment of $16 million and potential milestone payments [6] - **Sales Strategy**: Jaguar has transitioned its commercial responsibilities for Mytesi and Canalevia to FuturePak, allowing it to focus on its pipeline, particularly in rare diseases [11][12] Pipeline Focus - **Rare Disease Programs**: Jaguar is concentrating on ultra-rare diseases, specifically microvillus inclusion disease (MVID) and short bowel syndrome (SBS), with potential FDA filings by the end of 2026 [8][11] - **Market Potential**: The SBS market is estimated to be over $5 billion, with some estimates as high as $12 billion [12] - **Clinical Trials**: Ongoing trials for MVID and SBS are showing promising results, with significant reductions in parenteral nutrition for patients [16][25] Regulatory Pathways - **Breakthrough Designation**: The company is pursuing breakthrough therapy designation from the FDA, which could expedite the approval process for its rare disease treatments [28][29] - **Prime Designation in Europe**: This designation would facilitate communication and speed up the regulatory process across the EU [29] Canalevia-CA1 Update - **FDA Approval**: Canalevia-CA1 received conditional approval for chemotherapy-induced diarrhea in dogs, with ongoing studies required for full approval [32][33] - **Clinical Trial Funding**: Funds from the licensing agreement and grants will support the clinical trial for Canalevia-CA1 [34] Key Milestones for 2026 - **Clinical Trials**: Completion of MVID and SBS trials, with expectations for breakthrough and prime designations [38] - **Business Development**: Focus on securing business development deals independent of Mytesi and Canalevia, targeting rare disease indications [38] Additional Insights - **Patient Impact**: The company emphasizes the importance of supportive care in treating chronic conditions, particularly in the HIV community [10][11] - **Manufacturing as Profit Center**: Jaguar continues to manufacture crofelemer, which has become a profit center due to its commercialization by FuturePak [8] This summary encapsulates the key points discussed during the Jaguar Health FY Conference Call, highlighting the company's strategic focus, product pipeline, and market opportunities.

SAN FRANCISCO, CA / ACCESS Newswire / January 14, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that Lisa Conte, the company's founder, president and CEO, will present virtually on Thursday, January 15, 2026 at the Lytham Partners Healthcare Investor Summit. Participation Instructions for Jaguar's Virtual Presentation at the Lytham Partners Healthcare Investor Summit When: Thursday, January 15, 2026 at 3:30 PM Eastern Registration link for conference: Click Here Replay: A replay of the webcast wi ...

$18M upfront payment to Jaguar ($16M upon deal closing and $2M upon completion of post-closing conditions) Up to additional $20M in milestone and other future payments Future Pak becomes exclusive U.S. marketer for Mytesi® and Canalevia®-CA1 Jaguar continues to be the manufacturer of Mytesi and Canalevia-CA1 Meaningful non-dilutive capital enables Jaguar to focus on its rare-disease pipeline, which is the subject of ongoing BD discussions with other potential partners SAN FRANCISCO, CA / ACCESS Newswire / J ...

Article discusses results demonstrating parenteral support (PS) reduction ranging from 12 to 37% in ongoing proof-of-concept study of crofelemer in pediatric patients with intestinal failure Associated with significant toxicities to patients, PS has a lethal natural history, and PS reduction can potentially extend and save lives SAN FRANCISCO, CA / ACCESS Newswire / January 6, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced that an article published December 29, 2025 in HEALTH, a bi-monthl ...

Core Viewpoint - Jaguar Health, Inc. has received a $240,000 grant from the U.S. Food and Drug Administration's Center for Veterinary Medicine for its product Canalevia-CA1, which is conditionally approved for treating chemotherapy-induced diarrhea in dogs [1]. Company Summary - The grant awarded to Jaguar Health, Inc. amounts to $240,000 [1]. - Canalevia-CA1 is currently conditionally approved for use in dogs suffering from chemotherapy-induced diarrhea [1].

Summary of Jaguar Health Conference Call - December 10, 2025 Company Overview - **Company Name**: Jaguar Health - **Ticker Symbol**: JAGX - **Industry**: Pharmaceuticals - **Focus**: Developing proprietary prescription medicines derived from plants for gastrointestinal distress in humans and animals [1][2] Key Announcements - **Canalivia Approval**: - FDA approved the renewal of conditional approval for Canalivia, a drug for chemotherapy-induced diarrhea in dogs [2][4] - This drug is plant-based, organic, and sustainably harvested [2] - Represents an unmet medical need in veterinary medicine, as there are no other approved treatments for this condition in dogs [3] - **Financial Support**: - Received a $250,000 grant to support the trial design for full approval of Canalivia [4] - Stock price increased by 20%-25% following the announcement [5] - **Expansion Plans**: - Seeking to expand the indication from chemotherapy-induced diarrhea to all types of diarrhea in dogs [5][6] - Filed for advice with the European Medicines Agency (EMA) to potentially gain approval for acute diarrhea in dogs based on existing trial data [5][12] Market Insights - **Veterinary Market Size**: - Approximately 90 million dogs in the U.S., with an estimated 15% experiencing acute diarrhea at some point [9] - About 50% of dogs over the age of 10 are expected to experience cancer, leading to a significant need for supportive care [7][8] - **Mechanism of Action**: - Canalivia works by normalizing ion flow in the gut, which mitigates dehydration and water loss associated with diarrhea [10] - Current treatments often involve unapproved antibiotics, which are facing scrutiny due to resistance issues [10] Regulatory Considerations - **Conditional Approval**: - Conditional approval allows for limited promotion and prescribing, necessitating full approval for broader use [13] - The company aims to secure full approval within five years through confirmatory studies [4] Future Catalysts - **Upcoming Developments**: - 2025 is expected to be a pivotal year with multiple catalysts based on clinical data and regulatory clarity [15] - Focus on partnerships to enhance business development and secure non-dilutive funding [11] Conclusion - Jaguar Health is positioned to address significant unmet needs in the veterinary market with its plant-based therapies, particularly for gastrointestinal issues in dogs. The company is actively pursuing regulatory approvals and market expansion, which could lead to substantial growth opportunities in the coming years [1][15]

Conditional approval extended through December 2026 for the treatment of CID in dogs CID confirmatory effectiveness trial expected to conclude in February 2026, ahead of FDA's June deadline - 51 dogs enrolled to date; ~49 more expected SAN FRANCISCO, CA / ACCESS Newswire / December 10, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that the U.S. Food and Drug Administration (FDA) has granted renewal of the conditional approval for Canalevia-CA1 (crofelemer delayed-release tablets). Canalevia-CA1, ...

Jaguar CEO Lisa Conte presenting December 10 from 3:25pm - 3:35pm Eastern at the Emerging Growth Conference to provide updates on near-term catalysts; Click here to register Initial results of ongoing investigator-initiated proof-of-concept trial demonstrate crofelemer can potentially extend the lives of infants born with intestinal failure due to microvillus inclusion disease (MVID), reducing the volume of the total parenteral support (PS) necessary for them to survive, though with associated toxicity; Gro ...