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) news covers a commercial-stage pharmaceuticals company focused on plant-based prescription medicines for gastrointestinal distress in humans and animals. The company’s updates frequently highlight progress across its crofelemer programs, regulatory interactions, and partnerships.
Investors following JAGX news can expect coverage of developments related to Mytesi, Napo Pharmaceuticals’ FDA-approved crofelemer product for noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy, as well as Jaguar’s broader intestinal failure program targeting rare disorders such as short bowel syndrome with intestinal failure (SBS-IF) and microvillus inclusion disease (MVID). News items often describe clinical trial milestones, proof-of-concept data on reductions in parenteral support, and discussions with regulators about potential expedited approval pathways for ultrarare pediatric indications.
On the animal health side, Jaguar news includes information about Canalevia-CA1, the company’s conditionally approved crofelemer-based prescription drug for chemotherapy-induced diarrhea in dogs, along with regulatory grants, conditional approval renewals, and studies designed to support full approval. Updates may also address efforts to obtain guidance from the European Medicines Agency for Canalevia in general diarrhea in dogs.
Corporate and capital markets announcements are another key component of JAGX news. These can include securities purchase agreements, royalty interest amendments, PIPE financings, preferred stock exchanges, and at-the-market offering amendments, as disclosed in Form 8-K filings. Conference presentations, investor summit appearances, and summaries of stockholder meeting results also appear in the company’s news flow.
For investors and observers, the Jaguar Health news page provides a centralized view of clinical, regulatory, commercial, and financing developments that shape the company’s strategy in plant-based gastrointestinal therapeutics for both human and veterinary medicine.
Jaguar Health (NASDAQ:JAGX) said Napo Pharmaceuticals submitted an amended protocol to the FDA on November 20, 2025 to support a possible expedited approval pathway for crofelemer to treat intestinal failure in pediatric patients with microvillus inclusion disease (MVID).
Company cites investigator-initiated trial data showing parenteral support (PS) reductions of 12–37% in pediatric intestinal failure patients and up to 27%–37% PS reduction in the initial MVID patient. Jaguar also discussed potential review with the EMA and is supplying crofelemer for two U.S. expanded access programs.
Jaguar Health (NASDAQ: JAGX) reported Q3 2025 net revenue of ~$3.1M, up ~4% versus Q2 2025, with Mytesi prescription volume up ~0.9% sequentially but down ~3.6% year-over-year. The company recorded a net loss attributable to common stockholders of $9.5M and non-GAAP recurring EBITDA of -$8.9M. License revenue of $42,858 was recognized and deferred contract revenue totaled ~ $595k as of September 30, 2025.
Clinical update: investigator-initiated proof-of-concept data suggest crofelemer may extend survival and reduce parenteral support volume by up to 37% in infants with MVID, though associated toxicity was reported. Jaguar met with the FDA on October 2, 2025 to discuss an expedited approval pathway for a placebo-controlled crofelemer trial.
Jaguar Health (NASDAQ:JAGX) announced it will file its Form 10-Q for the quarter ended September 30, 2025 on November 14, 2025 and will host an investor webcast to review Q3 2025 financials and corporate updates.
The webcast is scheduled for Monday, November 17, 2025 at 8:30 AM Eastern. Registration and participant access are available via the company’s registration link.
Jaguar Health (NASDAQ:JAGX) recap of a November 8, 2025 NASPGHAN presentation reported initial proof-of-concept results for crofelemer in pediatric intestinal failure (including MVID and SBS-IF).
The independent IIT in the UAE showed reductions in total parenteral support (PS) ranging from 12% to 37%: two SBS-IF patients had PS reductions of 12.5–15.6% over 12 weeks; one MVID patient showed up to 27% reduction in 12 weeks and up to 37% during an extension after reinitiation. Findings included reduced loose watery stools and support continued evaluation and placebo-controlled trials across U.S., EU and Middle East sites.
Jaguar Health (NASDAQ:JAGX) reminded investors that partial results from an investigator-initiated proof-of-concept trial of crofelemer in pediatric intestinal failure will be presented on November 8, 2025 at NASPGHAN.
Initial open-label UAE data show reductions in total parenteral support (PS) of 12%–37% in pediatric patients including microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF). The company is supporting a placebo-controlled pediatric MVID trial across the U.S., EU and Middle East, supplying crofelemer for two FDA-authorized expanded access programs in the U.S., and supporting an IIT in U.S. adult SBS-IF patients.
Jaguar Health (NASDAQ:JAGX) announced on October 24, 2025 that, effective October 20, 2025, it granted inducement restricted stock units (RSUs) under Nasdaq Listing Rule 5635(c)(4).
The company awarded 600 RSUs to New Employee 1, 600 RSUs to New Employee 2, and 300 RSUs to New Employee 3, for a total of 1,500 RSUs. Each grant vests over one year from the employee's hire date and is conditioned on continued service through the applicable vesting dates. The grants were approved by Jaguar's Compensation Committee as material inducements to employment.
Jaguar Health (NASDAQ:JAGX) reported that its family company Napo met with the FDA on October 2, 2025 to seek advice on advancing a crofelemer powder oral solution development program for microvillus inclusion disease (MVID), an ultrarare pediatric disorder. The company said the FDA discussion identified potential opportunities to amend the ongoing study so a small, adequately controlled trial could support approval.
An investigator-initiated UAE trial patient showed a 37% weekly reduction in total parenteral support and a 30% reduction in total parenteral nutrition after reinitiation of crofelemer. Orphan designations exist from FDA and EMA; expanded access programs in the U.S. are authorized. An abstract was accepted for NASPGHAN Nov 5-8, 2025.
Jaguar Health (NASDAQ:JAGX) announced FDA authorization for expanded access programs using their novel crofelemer powder for oral solution to treat two pediatric intestinal failure patients with microvillus inclusion disease (MVID). The programs operate under separate Single-Patient Investigational New Drug applications in the US.
Initial proof-of-concept results from ongoing investigator-initiated trials showed that crofelemer reduced required total parenteral nutrition (TPN) by up to 27% in MVID patients and up to 12.5% in SBS-IF patients. The company expects additional trial results in 2025 and data from placebo-controlled studies in 2026.
Jaguar aims to pursue expedited regulatory pathways and potential early access programs in Europe, targeting a market of approximately 200 MVID patients worldwide and 10,000-20,000 SBS patients in both the US and Europe.
Jaguar Health (NASDAQ:JAGX) has received notice of a $250,000 FDA grant to fund a confirmatory trial for Canalevia-CA1, their conditionally approved treatment for chemotherapy-induced diarrhea (CID) in dogs. The grant would support studies required for full FDA approval, though the company has not yet accepted the award.
The company is in discussions with multiple animal health partners to expand Canalevia's indication to treat general diarrhea in dogs, targeting both U.S. and European markets. The potential market is substantial, with an estimated 11 million dogs suffering from general diarrhea annually in the U.S. and approximately 104 million dogs in Europe.
Canalevia contains crofelemer, a plant-based prescription drug that reduces diarrhea without using antibiotics. The drug is currently available through major U.S. veterinary distributors for CID treatment in dogs.
Jaguar Health (NASDAQ:JAGX) has submitted an orphan drug designation (ODD) application to the FDA for crofelemer, targeting diarrhea treatment in breast cancer patients with brain metastasis who are receiving targeted therapy with or without standard chemotherapy.
The application leverages FDA's recognition of brain metastasis as a distinct condition from primary cancers, evidenced by seven ODDs awarded between 2015-2024. If granted, the ODD would provide seven years of marketing exclusivity, tax credits for clinical testing, and filing fee relief.
The company plans to pursue Breakthrough Therapy and/or Fast Track designations to expedite regulatory pathways. Crofelemer already holds ODDs for short bowel syndrome, microvillus inclusion disease, and cholera-related diarrhea.
FAQ
What is the current stock price of Jaguar Health (JAGX)?
What is the market cap of Jaguar Health (JAGX)?
