Jaguar Health, Inc. (JAGX)

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, the company's prescription drug for the treatment of chemotherapy-induced diarrhea (CID) in dogs, is available from multiple leading veterinary distributors in the U.S., including Chewy.

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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; Groundbreaking PS reduction of up to 37%; No approved treatments exist for MVID Company completed meeting with FDA October 2, 2025 for advice on advancing its ongoing placebo-controlled trial of crofelemer in support of possible expedited approval pathway for crofelemer for treatment of MVID SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / December 8, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today announced the voting results of the Company's Special Meeting of Stockholders held on December 8, 2025 (the "Special Meeting"). Three proposals were submitted to and approved by the stockholders of the Company at the Special Meeting.

Jaguar's requesting advice from EMA on EU approval pathway for general diarrhea of FDA conditionally approved Canalevia® A novel non-antibiotic approach to diarrhea treatment is important because there are no FDA-approved drugs to treat general diarrhea in dogs, the second most common reason for visits to veterinary emergency hospitals SAN FRANCISCO, CA / ACCESS Newswire / December 2, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar), today announced that its Italian subsidiary, Napo Therapeutics S.p.A., has submitted a request to the European Medicines Agency (EMA) to have the EMA's Committee for Veterinary Medicinal Products (CVMP) provide scientific advice regarding the company's plan to pursue approval of Canalevia (crofelemer delayed-release tablets) in the European Union for treatment of general diarrhea in dogs based on data from a study Jaguar completed in 200 dogs in 2017.

This new IP supports crofelemer's global exclusivity in rare pediatric intestinal failure coincident with published clinical data showing reductions in parenteral support requirements with crofelemer - supporting Jaguar's strategy to secure non-dilutive partnership funding Recent publication by members of Jaguar's Scientific Advisory Board and other intestinal failure key opinion leaders: "Targeted Literature Review and Assessment of Evidence in Microvillus Inclusion Disease (MVID)" SAN FRANCISCO, CA / ACCESS Newswire / November 24, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced that the Australian Patent Office has issued a new patent to Jaguar family company Napo Pharmaceuticals (Napo) for methods for treating short bowel syndrome (SBS), bile acid diarrhea, and diarrhea associated with small intestine resection or gallbladder removal, in patients with an inhibitor of chloride-ion transport such as crofelemer, Jaguar's novel plant-based prescription drug. "This new patent expands the international IP protection supporting crofelemer's development in short bowel syndrome with intestinal failure (SBS-IF)," said Lisa Conte, founder, president, and CEO.

Crofelemer can potentially extend lives of MVID patients - infants and children who face the lethal natural history of the disease Parenteral support reduction of up to 37% is groundbreaking; No approved treatments exist for MVID in any region SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / November 20, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that, in support of a possible expedited approval pathway for crofelemer for treatment of intestinal failure in patients with the ultrarare genetic disorder microvillus inclusion disease (MVID), the company has submitted an amended protocol to the U.S. Food and Drug Administration (FDA) for the company's ongoing placebo-controlled clinical trial of crofelemer in pediatric MVID patients. MVID patients are born without the ability to absorb the basic nutrients of life, and are therefore subject to a lethal natural history and a lifetime of parenteral support which is associated with toxicities and comorbidities.

Jaguar Health, Inc. ( JAGX ) Q3 2025 Earnings Call November 17, 2025 8:30 AM EST Company Participants Lisa Conte - Founder, CEO, President & Director Carol Lizak - Chief Financial Officer Presentation Operator Greetings, and welcome to the Jaguar Health's Investor Webcast. [Operator Instructions] As a reminder, this conference is being recorded.

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; Groundbreaking PS reduction of up to 37%; No approved treatments exist for MVID Company completed meeting with FDA October 2, 2025 for advice on possible expedited approval pathway to advance its ongoing placebo-controlled trial of crofelemer for potential approval for treatment of MVID REMINDER: Today Jaguar to host investor webcast at 8:30 a.m. Eastern regarding Q3 2025 financials and company updates; Click here to register SAN FRANCISCO, CA / ACCESS Newswire / November 17, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today reported its consolidated third-quarter 2025 financial results.

Click here to register Company plans to file its Earnings Report on November 14, 2025 on Form 10-Q for the quarter ended September 30, 2025 SAN FRANCISCO, CA / ACCESS Newswire / November 14, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that the company will conduct an investor webcast on Monday, November 17, 2025, at 8:30 a.m. Eastern to review third-quarter 2025 financials and provide corporate updates.

Crofelemer can potentially extend and save lives of microvillus inclusion disease patients, reducing the volume of the total parenteral support (PS) necessary for them to survive Groundbreaking PS reduction of up to 37% is unprecedented; No approved treatments exist for MVID SAN FRANCISCO, CA / ACCESS Newswire / November 13, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today provided a recap of the November 8, 2025 presentation at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting describing the initial groundbreaking results of an independent investigator-initiated trial (IIT) of crofelemer in the UAE for treatment of pediatric intestinal failure, which includes patients with ‘intestinal failure' due to microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF). "The intestines of patients with the ultrarare genetic disorder MVID do not function properly, as is often the case with patients having intestinal failure due to short bowel syndrome.

Results of ongoing investigator-initiated proof-of-concept trial of crofelemer in United Arab Emirates (UAE) demonstrate disease progression modification and reduction of total parenteral support (PS) in pediatric intestinal failure patients ranging between 12% to 37% SAN FRANCISCO, CA / ACCESS Newswire / November 6, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today issued a reminder that an abstract describing partial results of the independent and ongoing investigator-initiated trial (IIT) of crofelemer in the UAE for treatment of pediatric intestinal failure, which includes patients with intestinal failure due to microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF), will be presented this coming Saturday, November 8, 2025, at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting taking place November 5-8, 2025 in Chicago. The results of the ongoing investigator-initiated proof-of-concept trial in the UAE demonstrate reduction of total parenteral support (PS) (comprised of total parenteral nutrition and supplementary IV fluids) in pediatric intestinal failure patients ranging between 12% to 37%.

SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / October 24, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today announced that, effective October 20, 2025, the Company granted 600 restricted stock units (RSUs) to New Employee 1, 600 RSUs to New Employee 2, and 300 RSUs to New Employee 3. The RSUs for New Employees 1, 2 and 3 vest over one year starting from each employee's date of hire.

Additional update: Results of ongoing investigator-initiated proof-of-concept trial in United Arab Emirates (UAE) demonstrate further reduction of total parenteral support (PS) (comprised of total parenteral nutrition and supplementary IV fluids) of approximately 37% SAN FRANCISCO, CA / ACCESS Newswire / October 6, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today provided its assessment of the company's Type C Meeting with the U.S. Food and Drug Administration (FDA) on October 2, 2025 to seek their advice for efficient advancement of the company's clinical trial of its novel crofelemer powder formulation for oral solution for the treatment of microvillus inclusion disease (MVID), an ultrarare pediatric disorder. Members of Napo's Scientific Advisory Board, including a key opinion leader who is the principial investigator for the ongoing open-label investigator-initiated trial (IIT) in the UAE, along with its other advisors, participated in this meeting.

The two programs are being conducted under separate Single-Patient Investigational New Drug (sIND) applications in the United States SAN FRANCISCO, CA / ACCESS Newswire / September 30, 2025 / Jaguar Health (NASDAQ:JAGX) today announced that Jaguar family company Napo Pharmaceuticals (Napo) is providing the company's novel crofelemer powder for oral solution for use in two expanded access programs, authorized by the U.S. Food and Drug Administration (FDA), to treat pediatric intestinal failure patients with microvillus inclusion disease (MVID). "Napo is committed to providing the novel crofelemer formulation as an investigational drug as deemed medically necessary by the physician caregiver for these two patients, intended for mitigating the sequela from MVID disease progression," said Pravin Chaturvedi, PhD, Napo's and Jaguar's Chief Scientific Officer and Chair of the Scientific Advisory Board.

Company strategy: In discussions with multiple potential animal health company partners to expand the indication and commercialize Canalevia for treatment of general diarrhea globally SAN FRANCISCO, CA / ACCESS Newswire / September 25, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar"), under its Jaguar Animal Health tradename for the veterinary market, today announced that it has received notice from the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) of a $250,000 grant. Canalevia, under the name Canalevia-CA1, is currently conditionally approved for chemotherapy-induced diarrhea (CID) in dogs.

Potential treatment for patients with breast cancer with metastasis to the brain with crofelemer would augment the significant responder analysis results for crofelemer in the prespecified subgroup of patients with breast cancer from the OnTarget study that were reported at the Multinational Association of Supportive Care in Cancer 2025 Annual Meeting and the 2024 San Antonio Breast Cancer Symposium SAN FRANCISCO, CA / ACCESS Newswire / September 24, 2025 / Jaguar Health (NASDAQ:JAGX) today announced that Jaguar family company Napo Pharmaceuticals (Napo) has submitted an orphan drug designation (ODD) application to the U.S. Food and Drug Administration (FDA) for crofelemer, the company's novel prescription drug, for the treatment of diarrhea in adult patients with breast cancer that has metastasized to the brain receiving targeted therapy with or without standard chemotherapy. Within the last ten years, the FDA's Office of Orphan Products Development (OOPD) has publicly acknowledged that brain metastasis of any cancer is considered a disease or condition separate and distinct from the primary site of origin.