FDA Feedback Supports Extension Phase for Jaguar Health's Clinical Trial of Crofelemer for Treatment of Microvillus Inclusion Disease (MVID)
Rhea-AI Summary
Jaguar Health (NASDAQ:JAGX) said FDA feedback supports a protocol amendment to permit a single-blind extension of Napo's crofelemer trial in pediatric microvillus inclusion disease (MVID). The extension aims to assess longer-term clinical benefit by reducing parenteral support (PS), with dose selection by an independent DMC.
Approximately 30% of patients have completed the double-blind phase; sites include the US, Italy and UAE. Company highlighted potential for a Breakthrough Therapy designation to enable expedited pathways.
Positive
- FDA supported amendment enabling single-blind extension
- Approximately 30% of patients completed double-blind phase
- Trial active at sites in US, Italy, UAE
- Extension aims to reduce parenteral support (PS)
Negative
- MVID has an extremely low incidence and prevalence
- No approved therapies exist; patients require lifelong PS
News Market Reaction – JAGX
In the Mar 18 session, JAGX declined 8.04%, reflecting a notable negative market reaction. Argus tracked a trough of -22.5% from its starting point during tracking. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Nov 20 | Protocol amendment | Positive | -8.2% | Amended MVID trial protocol submitted to FDA for potential expedited approval. |
| Sep 24 | Orphan designation move | Positive | +7.0% | Filed orphan drug designation application for crofelemer in cancer therapy-related diarrhea. |
| May 20 | Phase 2 enrollment | Positive | +1.4% | First patient randomized in Phase 2 crofelemer trial for pediatric MVID. |
| Dec 18 | Phase 2 initiation | Positive | -8.5% | Phase 2 study initiated for crofelemer in MVID with orphan designations in place. |
| Oct 08 | CTD study abstract | Neutral | +0.0% | Submitted late-breaking abstract analyzing diarrhea from cancer therapies in Phase 3 trial. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical-trial and regulatory updates for crofelemer have produced mixed reactions, with both double-digit gains and selloffs, and an average move of -1.66% around similar announcements.
Over the past year, Jaguar has steadily advanced crofelemer in rare-disease settings. Key clinical milestones include Phase 2 initiation for MVID on Dec 18, 2024, first patient randomization on May 20, 2025, and an amended protocol submitted to the FDA on Nov 20, 2025 to support expedited pathways. Additional regulatory efforts include an orphan drug designation application for cancer therapy-related diarrhea. Today’s FDA-supported extension phase for the MVID trial fits this pattern of seeking accelerated approval routes in ultrarare indications.
Key Terms
parenteral support medical
total parenteral nutrition medical
data monitoring committee medical
institutional review boards regulatory
breakthrough therapy designation regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
MVID has a lethal natural history requiring life-sustaining parenteral support (PS), which includes total parenteral nutrition (TPN), which is associated with significant toxicities; PS reduction could potentially reduce co-morbidities and improve clinical benefit, as no approved therapies exist for MVID
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SAN FRANCISCO, CA / ACCESS Newswire / March 18, 2026 / Jaguar Health, Inc.(NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that, based on the U.S. Food and Drug Administration (FDA) support for Napo's protocol amendment for its clinical trial to evaluate the safety and efficacy of its novel crofelemer powder-for-oral-solution formulation in pediatric patients with intestinal failure due to MVID, an ultrarare pediatric disorder, Napo plans to initiate a single-blind extension phase for the trial. The extended treatment period has the potential to improve clinical benefit of crofelemer through reduction of parenteral support (PS) requirements, which may result in disease progression-modification of MVID.
"We are pleased to have the opportunity to continue treatment with crofelemer powder for oral solution in our ongoing clinical trial of crofelemer in pediatric MVID patients," said Pravin Chaturvedi, PhD, Jaguar's Chief Scientific Officer and Chair of the Jaguar and Napo Scientific Advisory Board. "This would allow patients who have completed their double-blind treatment period to be eligible for the single-blind phase of continued treatment with crofelemer for further assessment of clinical benefit through reduction of PS for a longer period. PS reduction could potentially reduce co-morbidities associated with the disease and TPN; thus improving clinical benefit and modifying the disease progression to help address the lethal natural history of MVID."
The dose selection for the single-blind extension phase will be determined by the study's independent Data Monitoring Committee (DMC), which will ensure that the study clinicians and Napo personnel will remain blinded. Currently, approximately
This trial of crofelemer in MVID patients has clinical sites in the US, Italy and the UAE, and the consent from the FDA, the European Medicines Agency (EMA), The Ministry of Health and Prevention (MOHAP), and the Institutional Review Boards (IRBs) for each site.
"Our development plan for this ultrarare disease, with an expected improved clinical benefit from the longer treatment in the extension phase, may also support the possibility for a Breakthrough Therapy designation from the FDA in the coming months, potentially supporting opportunities for expedited regulatory submission pathways to the FDA for new drug approval for this ultrarare pediatric disorder," said Lisa Conte, Jaguar's founder, president, and CEO. "The extremely low incidence and prevalence of MVID, its lethal natural history and the fact that no therapies are available for MVID other than lifelong PS, underscores the need for new therapies. Together with the support of MVID clinical key opinion leaders (KOLs), we are exploring expedited regulatory pathways for crofelemer."
About the Jaguar Health Family of Companies
Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including MVID and short bowel syndrome.
For more information about:
Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit www.napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that Napo will initiate a single-blind extension phase for its MVID trial, the expectation that PS reduction could potentially reduce co-morbidities associated with MVID and TPN, thus improving clinical benefit and modifying the disease progression to help address the lethal natural history of MVID, and Jaguar's expectation that its development plan for MVID may support the possibility for a Breakthrough Therapy designation from the FDA in the coming months, potentially supporting opportunities for expedited regulatory submission pathways to the FDA for new drug approval. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Contact:
hello@jaguar.health
Jaguar-JAGX
SOURCE: Jaguar Health, Inc.
View the original press release on ACCESS Newswire