Jaguar Health Announces Abstract Submission for Preliminary Data from US Investigator-Initiated Trial of Crofelemer in Adult Patients with Short Bowel Syndrome with Intestinal Failure (SBS-IF)

Rhea-AI Summary

Jaguar Health (NASDAQ:JAGX) said an independent investigator submitted an abstract reporting preliminary clinical findings for a novel oral liquid formulation of crofelemer in adult short bowel syndrome with intestinal failure (SBS-IF); the abstract was submitted for consideration at Digestive Disease Week® May 2-5, 2026.

The release highlights prior independent trial results: crofelemer reduced parenteral support (PS) by 12–15.6% in two pediatric SBS-IF patients over 12 weeks, and by up to 27% (and up to 37% on extension) in an initial MVID patient. Jaguar completed an FDA meeting in October 2025 on a possible expedited pathway for MVID. Crofelemer holds Orphan Drug Designation in the US and EU for SBS and MVID.

Positive

• Crofelemer reduced PS by 12–15.6% in two pediatric SBS-IF patients over 12 weeks
• Initial MVID patient showed PS reduction up to 27% over 12 weeks and up to 37% on extension
• FDA meeting completed in October 2025 on a possible expedited approval pathway for MVID
• Orphan Drug Designation granted by FDA and EMA for SBS and MVID

Negative

• Preliminary data come from a very small number of treated patients (two pediatric SBS-IF completers and one MVID completer)
• US adult SBS-IF findings are at abstract-submission stage and not yet peer-reviewed or publicly presented

News Market Reaction – JAGX

-11.85%

9 alerts

-11.85% Session close to close

+2.0% Peak Tracked

-17.7% Trough Tracked

$5.80M Market Cap

0.5x Rel. Volume

In the Dec 15 session, JAGX declined 11.85%, reflecting a significant negative market reaction. Argus tracked a peak move of +2.0% during that session. Argus tracked a trough of -17.7% from its starting point during tracking. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock dropped -11.8% in the session following this news. A negative reaction despite clinically ...

Analysis

The stock dropped -11.8% in the session following this news. A negative reaction despite clinically oriented news fits the mixed pattern seen after prior updates, where two positive crofelemer milestones saw declines of 1.28% and 8.15%. The announcement centers on an abstract submission and early data rather than registrational outcomes, while shares already trade about 95.94% below the 52-week high. Existing debt, prior financings, and an effective S-3 shelf may also color sentiment around otherwise constructive development progress.

Key Figures

PS reduction range: 12–37% SBS-IF PS reduction: 12.5–15.6% MVID PS reduction (initial): Up to 27% +5 more

8 metrics

PS reduction range 12–37% Proof-of-concept trial in pediatric intestinal failure patients

SBS-IF PS reduction 12.5–15.6% Two pediatric SBS-IF patients over a 12-week treatment period at highest crofelemer dose

MVID PS reduction (initial) Up to 27% Initial MVID patient over 12-week crofelemer treatment period

MVID PS reduction (extension) Up to 37% Initial MVID patient during extension period upon crofelemer reinitiation

SBS US prevalence 10,000–20,000 people Estimated US SBS patient population from Crohn's & Colitis Foundation

MVID prevalence 100–200 patients Estimated worldwide prevalence of microvillus inclusion disease (MVID)

PS duration Up to 7 days/week, 20+ hours/day Typical parenteral support burden for intestinal failure patients

Conference dates May 2–5, 2026 Proposed presentation window at Digestive Disease Week for SBS-IF abstract

Historical Context

5 past events · Latest: Dec 10 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Dec 10	Veterinary FDA renewal	Positive	+13.7%	FDA renewed conditional approval of Canalevia-CA1 for chemotherapy-induced diarrhea in dogs.
Dec 08	Stockholder approvals	Positive	+1.9%	Stockholders approved all proposals tied to financings and highlighted positive MVID clinical progress.
Dec 02	EMA advice request	Positive	-1.3%	Company sought EMA scientific advice on EU approval pathway for Canalevia in dogs.
Nov 24	New SBS patent	Positive	+5.0%	Australian patent granted for crofelemer use in SBS and related GI conditions with supporting IIT data.
Nov 20	MVID trial update	Positive	-8.2%	Amended FDA protocol for pediatric MVID trial aiming at a possible expedited approval pathway.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent company-specific news has produced mixed reactions: three positive regulatory/clinical updates saw aligned gains, while two similarly positive development updates were met with declines.

Recent Company History

Over the last month, Jaguar reported multiple crofelemer milestones. On Nov 20 (news_id 939167), it filed an amended MVID trial protocol to support an expedited pathway, followed by new SBS-related IP and proof-of-concept data on Nov 24 (news_id 940178). In early December, it sought EMA input for Canalevia in Europe and secured stockholder approvals for financing-related proposals. On Dec 10 (news_id 946342), the FDA renewed conditional approval for Canalevia-CA1 in dogs. Today’s SBS-IF abstract submission extends this ongoing intestinal failure and orphan GI focus.

Key Terms

orphan disease, investigator-initiated, parenteral support, total parenteral nutrition (TPN), +4 more

8 terms

orphan disease medical

"SBS-IF is the second orphan disease target indication for Jaguar's intestinal failure program"

A rare medical condition that affects a very small number of people, often so few that standard drug development and commercial sales are impractical. For investors it matters because treatments for these conditions can qualify for special regulatory incentives, faster approval paths and price premiums, so a successful therapy is like owning a product that dominates a tiny but underserved niche market — high potential reward but also higher scientific and commercial risk.

investigator-initiated medical

"Napo's independent investigator at a leading SBS-IF treatment institution submitted an abstract"

An investigator-initiated study is a research project started and run by a doctor, scientist, or academic institution rather than by a drug or device company; the investigator designs the study, enrolls patients, and often arranges funding or support. For investors, these studies can produce independent data that may strengthen or weaken a product’s prospects, like a customer-run test revealing real-world performance outside the maker’s control.

parenteral support medical

"reducing dependence on parenteral support remains a critical unmet need"

Parenteral support is medical care that delivers nutrition, fluids or medications directly into a patient’s bloodstream or body tissues, bypassing the digestive system—think of it as feeding or hydrating someone through an IV rather than by mouth. Investors care because this service involves specialized products, durable revenue from long-term patient use, strict safety and reimbursement rules, and potential regulatory or supply risks that affect company earnings and growth.

total parenteral nutrition (TPN) medical

"consists of total parenteral nutrition (TPN) with supplemental intravenous fluids"

Total parenteral nutrition (TPN) is a medical treatment that delivers all essential nutrients—calories, protein, electrolytes, vitamins and fluids—directly into a patient’s bloodstream through a vein when they cannot eat or digest food. Investors care because TPN drives revenue and costs across hospitals, specialty pharmacies, device makers and drug suppliers; changes in patient demand, safety issues, regulatory rules or reimbursement can materially affect sales, margins and supply chains, similar to how fuel shipments matter to transportation companies.

expanded access programs regulatory

"supporting evaluation of crofelemer powder for oral solution in expanded access programs"

Expanded access programs let patients who are seriously ill and ineligible for clinical trials receive an investigational drug or therapy outside the trial system, often when no approved treatment exists. For investors, these programs matter because they can provide early real-world use that affects demand, public perception, regulatory scrutiny and safety data—like letting a handful of customers test a prototype product before full market approval, with both potential upside and risk.

orphan drug designation regulatory

"Crofelemer has been granted Orphan Drug Designation by the U.S. Food and Drug Administration"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

placebo-controlled medical

"Napo is conducting a placebo-controlled clinical trial of crofelemer in adult SBS-IF patients"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

parenteral nutrition medical

"demonstrate disease progression modification through reduction of PS in pediatric intestinal failure"

Parenteral nutrition is the medical delivery of nutrients and fluids directly into a patient’s bloodstream, usually through an IV, when they cannot eat or absorb food normally—think of it as providing a car with fuel through a hose instead of filling the tank. It matters to investors because it represents a steady, often high-margin product and service line in healthcare; demand, supply chain reliability, regulatory approvals, and reimbursement rates can materially affect revenues and profitability for companies that make or provide these solutions.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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SBS-IF is the second orphan disease target indication for Jaguar's intestinal failure program, which includes microvillus inclusion disease (MVID) - for which the company completed a meeting in October 2025 with the FDA in support of a possible expedited approval pathway

SAN FRANCISCO, CA / ACCESS Newswire / December 15, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced that Jaguar family company Napo Pharmaceuticals' (Napo's) independent investigator at a leading SBS-IF treatment institution submitted an abstract describing preliminary findings from a clinical trial evaluating a novel oral liquid formulation of crofelemer in adult SBS-IF patients. This abstract is for consideration for presentation at the May 2-5, 2026 Digestive Disease Week^® conference. The submission supports Jaguar's strategic focus on intestinal failure in adult short bowel syndrome patients, where reducing dependence on parenteral support remains a critical unmet need. An overview of the study can be viewed on the ClinicalTrials.gov website. SBS-IF is the second orphan disease target indication for Jaguar's intestinal failure program, which includes the ultrarare genetic disorder microvillus inclusion disease (MVID). In October 2025 the company completed a meeting with the FDA in support of a possible expedited approval pathway for crofelemer for MVID.

"Findings from independent investigator-initiated studies provide proof-of-concept data and continue to build the evidence supporting crofelemer's ability to reduce stool and stomal output and the drug's potential to reduce parenteral support needs in patients with intestinal failure - a core focus of the company for treating rare and orphan GI disorders," said Lisa Conte, Jaguar's founder, president, and CEO.

The intestines of patients with intestinal failure due to short bowel syndrome are unable to function like an intact gut, a similar situation to that in patients with intestinal failure due to MVID. Intestinal failure is a debilitating condition that often requires patients to receive life-sustaining fluids, electrolytes and nutrients through intravenous administration, which consists of total parenteral nutrition (TPN) with supplemental intravenous fluids, which together constitute parenteral support (PS). Many intestinal failure patients require PS up to 7 days a week, and sometimes for 20 hours or more per day. While crucial for intestinal failure patients, PS is associated with significant toxicities to patients, similar to some toxicities associated with chemotherapy, often causing serious health problems including infections, metabolic complications, and liver and kidney function problems. These symptoms may emerge at any time in intestinal failure patients, and often become life-threatening.

As announced, and as presented November 8, 2025 at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting, the initial results of the ongoing and independent proof-of-concept trial of crofelemer in the United Arab Emirates demonstrate disease progression modification through reduction of PS in pediatric intestinal failure patients that ranged from 12 to 37%. Specifically, in two pediatric SBS-IF patients who have completed treatment, the results show crofelemer reduced PS between 12.5 to 15.6% at the highest dose over the 12-week treatment period, together with reduced loose watery stools frequency. For the initial MVID patient who has completed treatment, PS needs were reduced by up to 27% at the highest dose over the initial 12-week treatment period and up to 37% during the extension period upon reinitiation of crofelemer treatment, and showed reduced frequency of loose watery stools. These findings support continued evaluation of crofelemer to reduce PS needs for pediatric intestinal failure patients.

Short bowel syndrome (SBS) affects approximately 10,000 to 20,000 people in the US, according to the Crohn's & Colitis Foundation, and it is estimated that the population of SBS patients in Europe is approximately the same size. MVID is a devastating ultrarare pediatric disorder, with an estimated worldwide prevalence of 100-200 patients, characterized by severe malabsorption that requires life-sustaining parenteral support to meet the nutritional, fluid and electrolyte requirements of the child, and for which there are currently no approved treatments. MVID has a lethal natural history along with significant co-morbidities.

In addition to supporting the ongoing IIT at this US institution, Napo is conducting a placebo-controlled clinical trial of crofelemer in adult SBS-IF patients at sites in the EU, and a placebo-controlled clinical trial of crofelemer in pediatric MVID patients at sites in the US, EU, and Middle East. The company is also supporting evaluation of crofelemer powder for oral solution in expanded access programs to treat intestinal failure in pediatric patients with MVID in the US.

Crofelemer has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for SBS and MVID.

About Crofelemer

Crofelemer is a novel, oral plant-based highly purified prescription medicine from the crude plant latex (red bark sap), also referred to as "dragon's blood," of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities.

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 microvillus inclusion disease 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 an expedited approval pathway for crofelemer in the US may be possible. 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

FAQ

What did Jaguar Health (JAGX) announce on December 15, 2025 about crofelemer in SBS-IF?

Jaguar announced an abstract submission reporting preliminary clinical findings for a novel oral liquid crofelemer formulation in adult SBS-IF, submitted for Digestive Disease Week May 2-5, 2026.

How much did crofelemer reduce parenteral support (PS) in reported pediatric SBS-IF patients?

In two pediatric SBS-IF patients who completed treatment, crofelemer reduced PS by 12.5% to 15.6% at the highest dose over 12 weeks.

What PS reductions were reported for the initial MVID patient treated with crofelemer?

The initial MVID patient showed PS reductions up to 27% over the 12-week period and up to 37% during the extension after reinitiation.

Does crofelemer have orphan designation for SBS and MVID for JAGX investors?

Yes; crofelemer has been granted Orphan Drug Designation by both the FDA and the European Medicines Agency for SBS and MVID.

What is the near-term timeline for public presentation of the US adult SBS-IF data (JAGX)?

The abstract was submitted for consideration for presentation at Digestive Disease Week, scheduled for May 2-5, 2026.

What regulatory engagement did Jaguar complete for crofelemer in MVID?

Jaguar completed a meeting with the FDA in October 2025 regarding a possible expedited approval pathway for crofelemer in MVID.