Jaguar Health Inc Stock Price, News & Analysis

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.

Jaguar Health (NASDAQ:JAGX) announced the approval of all seven proposals at its August 2025 Annual Meeting of Stockholders. The company highlighted key clinical developments, including proof-of-concept results showing crofelemer reduced total parenteral nutrition by up to 27% in MVID patients and 12.5% in SBS-IF patients in an Abu Dhabi trial.

Following an FDA meeting, Jaguar outlined its regulatory pathway for a supplemental NDA for crofelemer in metastatic breast cancer patients. The company's strategy focuses on seeking business development partnerships for orphan indication products to secure non-dilutive funding.

Jaguar Health (NASDAQ:JAGX) subsidiary Napo Pharmaceuticals announced plans to meet with the FDA regarding crofelemer's development for treating Microvillus Inclusion Disease (MVID), an ultrarare pediatric disorder. Initial proof-of-concept results from an ongoing investigator-initiated trial in Abu Dhabi demonstrated that crofelemer reduced required total parenteral nutrition by up to 27% in the first MVID patient.

The company aims to discuss potential expedited regulatory pathways for this rare orphan indication. An abstract describing the trial results has been accepted for presentation at the NASPGHAN 2025 Annual Meeting in Chicago. Napo is currently conducting a placebo-controlled Phase 2 study of crofelemer in pediatric MVID patients across the U.S., EU, and Middle East/North Africa regions.

Jaguar Health (NASDAQ:JAGX) reported Q2 2025 financial results showing significant growth. Net revenue reached $3.0 million, marking a 35% increase from Q1 2025's $2.2 million and a 10% rise from Q2 2024. Mytesi prescription volume grew 6.5% quarter-over-quarter.

The company's financial performance showed mixed results with increased sales but wider losses. Net loss attributable to common stockholders increased to $10.4 million in Q2 2025 from $9.5 million in Q2 2024. Notable developments include positive initial proof-of-concept results from trials showing crofelemer reduced total parenteral nutrition requirements in MVID and SBS-IF patients by up to 27% and 12.5% respectively.

Jaguar Health (NASDAQ:JAGX) has scheduled two important investor events. The company will host an investor webcast on August 14, 2025, at 8:30 AM ET to discuss Q2 2025 financial results and provide corporate updates, coinciding with their 10-Q filing. Additionally, CEO Lisa Conte will present at the Emerging Growth Conference on August 20, 2025, from 2:55-3:05 PM ET to discuss near-term catalysts.

Both events will be accessible online, with the Emerging Growth Conference presentation being archived for later viewing on EmergingGrowth.com and their YouTube channel.