Jaguar Health Inc Stock Price, News & Analysis

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.

Jaguar Health (NASDAQ:JAGX) announced upcoming virtual presentations at two investor conferences. The company's founder, president and CEO Lisa Conte will present at the Emerging Growth Conference on September 25, 2025 from 2:55 - 3:05 PM ET and at the Lytham Partners Fall 2025 Conference on September 30, 2025 at 3:30 PM ET.

Both presentations will be available online with replay options through their respective platforms. The Emerging Growth Conference presentation will be archived on EmergingGrowth.com and their YouTube channel, while the Lytham Partners presentation replay will be accessible through their conference link.

Jaguar Health (NASDAQ:JAGX) announced its participation in the upcoming H.C. Wainwright 27th Annual Global Investment Conference, scheduled for September 8-10, 2025. The company's founder, president and CEO, Lisa Conte, will deliver a virtual presentation, which will be available on-demand starting at 7:00 AM Eastern on September 5, 2025.

The conference will be held in a hybrid format, offering both virtual access and in-person attendance at the Lotte New York Palace in New York City.

Jaguar Health (NASDAQ:JAGX) announced its participation in the 2025 Animal Health Summit with the goal of securing partnerships to expand Canalevia's indication from chemotherapy-induced diarrhea (CID) to general diarrhea treatment in dogs. Canalevia-CA1, their FDA conditionally approved plant-based drug, has reached 25% enrollment in its ongoing effectiveness study.

The company is in discussions with multiple potential animal health partners to achieve three key objectives: expanding U.S. indication to general diarrhea, obtaining EU approval, and maintaining U.S. availability for CID treatment. With an estimated 11 million dogs suffering from general diarrhea annually in the U.S. and a significant market in Europe's 104 million dog population, Jaguar sees substantial market potential.