Jaguar Health Inc Stock Price, News & Analysis

Jaguar Health (NASDAQ:JAGX) announced the FDA renewed the conditional approval for Canalevia-CA1 (crofelemer delayed-release tablets) for chemotherapy-induced diarrhea (CID) in dogs, effective through December 21, 2026. The company said this renewal represents the fifth and final allowable year of conditional approval.

A confirmatory effectiveness trial is underway and is expected to conclude in February 2026, ahead of the FDA's June deadline; the study has enrolled 51 dogs to date with approximately 49 more expected. Canalevia-CA1 is available from multiple leading U.S. veterinary distributors, including Chewy.

Jaguar Health (NASDAQ:JAGX) reported that stockholders approved all three proposals at the Special Meeting held on December 8, 2025. The company highlighted early clinical and regulatory developments for crofelemer in microvillus inclusion disease (MVID): an investigator-initiated proof-of-concept trial showed crofelemer may extend infant lives and reduce total parenteral support (PS) volumes by up to 37%, though the report notes associated toxicity. Jaguar completed a meeting with the FDA on October 2, 2025 to seek advice on advancing its placebo-controlled crofelemer trial toward a possible expedited approval pathway. CEO Lisa Conte will present updates on December 10, 2025, 3:25–3:35 PM ET at the Emerging Growth Conference.

Jaguar Health (NASDAQ:JAGX) said its Italian unit submitted a request to the European Medicines Agency for CVMP scientific advice on pursuing EU approval of Canalevia (crofelemer) for general diarrhea in dogs based on a 2017 study of 200 dogs. The CVMP review is requested for its March 2026 meeting; EMA will have 60 days (extendable to 90) to respond. If EMA agrees the updated analysis supports approval, Jaguar would file a Marketing Authorization Application to sell Canalevia across the 27 EU member states. Jaguar also noted FDA conditional approval for chemotherapy-induced diarrhea in dogs and cited EU/US dog population and case estimates.

Jaguar Health (NASDAQ:JAGX) announced an Australian patent issued to Napo for methods treating short bowel syndrome (SBS), bile acid diarrhea, and post-resection diarrhea using an inhibitor of chloride-ion transport such as crofelemer (Nov 24, 2025).

Jaguar cited emerging proof-of-concept clinical data: two pediatric SBS-IF patients showed 12.5–15.6% reduction in parenteral support (PS) at 12 weeks; one MVID patient showed up to 27% reduction at 12 weeks and up to 37% on extension. Ongoing randomized trials and expanded access programs are active in US, EU, Middle East.

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.