Shares of Jaguar Health Inc. (NASDAQ:JAGX) are trading lower Thursday morning as investors evaluate the clinical development timeline for the company’s rare pediatric disease pipeline following an operational update.
- Jaguar Health stock is among today’s weakest performers. What’s pressuring JAGX stock?
Pediatric MVID Patients Advance to Extension Phase
Jaguar’s subsidiary, Napo Pharmaceuticals, announced Thursday that all randomized pediatric patients with Microvillus Inclusion Disease with intestinal failure enrolled in its pivotal crossover trial have entered the single-blind extension phase.
Under the extension, participants will receive blinded doses of crofelemer powder for oral solution to assess long-term safety and efficacy as an adjunctive treatment to parenteral support.
An independent Data Monitoring Committee authorized the continuation after reviewing safety and tolerability data from the randomized double-blind crossover period.
Targeting Mid-2027 NDA Submission
MVID is an ultrarare disorder characterized by severe intestinal failure that leaves pediatric patients unable to absorb essential nutrients, requiring lifelong parenteral nutrition.
The trial, spanning clinical sites across the United States, the European Union, and the United Arab Emirates, is intended to support a planned New Drug Application filing with the U.S. Food and Drug Administration by mid-2027.
Management Commentary Highlights Extended Dosing Milestone
Addressing the clinical progression, Pravin Chaturvedi, Chief Scientific Officer of Napo and Jaguar, noted the regulatory and safety progress:
“We are pleased that all randomized pediatric MVID patients will participate in the single-blind extension phase with blinded doses of crofelemer powder for oral solution. An independent Data Monitoring Committee evaluated the safety and tolerability of crofelemer during the randomized double-blind crossover period of the trial and authorized continuation of active crofelemer treatment for a longer period in the extension phase.”
JAGX Shares Slide Thursday Afternoon
JAGX Price Action: Jaguar Health shares were down 13.65% at 31 cents at the time of publication on Thursday. The stock is trading at a new 52-week low, according to Benzinga Pro data.
Image: Shutterstock
Login to comment