Jaguar Health presents crofelemer data at ESPGHAN 2026

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Shriram SScanX News Team
Key Highlights

Jaguar Health announced new clinical data for crofelemer presented at the ESPGHAN 2026 meeting, showing reductions in parenteral support of up to 48% in pediatric MVID patients and 40% in SBS-IF patients. The company plans to file an NDA with the FDA for the MVID indication in mid-2027. Additionally, Jaguar Health recently converted its Series O Convertible Preferred Stock into common stock.

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Jaguar Health, Inc. announced that its family company Napo Pharmaceuticals presented new data at the 58th Annual European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Meeting in Lille, France. The presentations highlighted the efficacy of oral liquid crofelemer as an adjunctive therapy for pediatric intestinal failure (IF) patients. The results demonstrated substantial reductions in parenteral support (PS) requirements, a critical metric for patients dependent on lifelong total parenteral nutrition.

The data presented showed that in one patient with microvillus inclusion disease (MVID), weekly PS requirements normalized to body weight were reduced by up to 48% following more than 12 months of liquid oral high-dose crofelemer therapy. Additionally, in two pediatric patients with short bowel syndrome with intestinal failure (SBS-IF), weekly PS requirements normalized to body weight were reduced by up to 40% over the same treatment period. The therapy was well tolerated with no significant clinical or laboratory abnormalities reported throughout the ongoing treatment period.

Jaguar Health remains focused on its global development program for crofelemer. The company is targeting Breakthrough Therapy designation for crofelemer for the indication of MVID, with a planned filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in mid-2027. The company stated that its intestinal failure program is expected to continue to provide clinical milestones and is the subject of business development discussions aimed at securing non-dilutive funds from potential licensee partners.

Clinical Trial Results Summary

Patient Category Reduction in Weekly PS Treatment Duration Tolerability
MVID Up to 48% >12 months No significant abnormalities
SBS-IF Up to 40% >12 months No significant abnormalities

Separately, Jaguar Health recently exercised its right to convert its Series O Convertible Preferred Stock into voting common stock. The conversion automatically took effect at 12:00 pm Eastern Time on June 25, 2026. Each share of Preferred Stock converted into 3.209 shares of Common Stock. Holders who would have received fractional shares received cash based on the fair value of the fractional interest, calculated at the closing price of $2.68 per share on June 24, 2026. The Preferred Stock was originally issued as a one-time special stock dividend to holders of Jaguar Common Stock and certain outstanding warrants as of the record date on March 2, 2026.

Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas. Its family companies, Napo Pharmaceuticals, Inc. and Napo Therapeutics S.p.A., focus on the development and commercialization of crofelemer.

What are the potential regulatory hurdles Jaguar Health might face in securing Breakthrough Therapy designation for crofelemer in MVID?

How will the conversion of Series O Preferred Stock to Common Stock impact Jaguar Health's shareholder structure and liquidity?

What strategic partnerships or licensing deals could emerge from the ongoing business development discussions for the intestinal failure program?

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Jaguar Health submits NADA for full approval of canine drug

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Reviewed by
Naman SScanX News Team
Key Highlights

Jaguar Health submitted a New Animal Drug Application to the FDA for full approval of crofelemer to treat chemotherapy-induced diarrhea in dogs. The drug, Canalevia-CA1, is currently conditionally approved. The submission seeks to meet all regulatory standards for full clearance.

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Jaguar Health, Inc. has submitted a New Animal Drug Application (NADA) to the U.S. Food and Drug Administration's Center for Veterinary Medicine for full approval of crofelemer to treat chemotherapy-induced diarrhea (CID) in dogs. The submission marks a significant step in the company's efforts to secure full regulatory clearance for its veterinary medicine.

Crofelemer, marketed under the brand name Canalevia-CA1, is currently conditionally approved for the treatment of CID in dogs. The NADA submission seeks to transition the drug from conditional to full approval, which would solidify its market position.

The application was filed with the FDA's Center for Veterinary Medicine, the regulatory body overseeing animal health products. Full approval would require the company to meet all necessary efficacy and safety standards outlined by the agency.

Jaguar Health's move underscores its commitment to advancing treatments for canine oncology patients. The company aims to address a critical need for effective therapies managing chemotherapy side effects in dogs.

What is the expected timeline for the FDA's review and decision on the full approval application?

How might full approval impact the commercial adoption and revenue potential of Canalevia-CA1?

Will Jaguar Health pursue similar regulatory pathways for crofelemer in other animal species or indications?

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