Article About Groundbreaking Results from Study of Jaguar Health's Crofelemer for Treatment of Intestinal Failure Featured in United Arab Emirates Healthcare Publication

Rhea-AI Summary

Jaguar Health (NASDAQ:JAGX) highlighted an article (Dec 29, 2025) summarizing initial proof‑of‑concept results for crofelemer in pediatric intestinal failure patients in the UAE.

Key findings: parenteral support (PS) reductions ranged 12–37%—two SBS-IF patients showed 12.5–15.6% PS reduction at the highest dose over 12 weeks; one MVID patient showed up to 27% reduction over 12 weeks and up to 37% during an extension after reinitiation. Results also reported reduced loose watery stools.

The company notes PS has serious toxicities and crofelemer’s PS reductions may be disease‑modifying. Crofelemer holds Orphan Drug Designation from FDA and EMA; additional placebo‑controlled trials and an FDA meeting regarding an expedited pathway were also reported.

Positive

• PS reduction 12–37% observed in UAE proof‑of‑concept study
• Two SBS‑IF patients showed 12.5–15.6% PS reduction over 12 weeks
• One MVID patient showed up to 27% reduction at 12 weeks and 37% on extension
• Orphan Drug Designation granted by FDA and EMA

Negative

• Very small sample size: results reported for 2 SBS‑IF and 1 MVID patients
• Proof‑of‑concept only: UAE study is ongoing and independent, not placebo‑controlled
• No pivotal or approval outcome reported; further placebo‑controlled trials ongoing

Key Figures

PS reduction range 12–37% Ongoing proof-of-concept crofelemer study in pediatric intestinal failure

SBS-IF PS reduction 12.5–15.6% Two pediatric SBS-IF patients over 12-week crofelemer treatment

MVID PS reduction (core) Up to 27% Initial pediatric MVID patient over first 12 weeks at highest dose

MVID PS reduction (extension) Up to 37% Extension period upon reinitiation of crofelemer treatment

SBS prevalence 10,000–20,000 people Estimated short bowel syndrome population in the US

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

PS frequency Up to 7 days/week Many intestinal failure patients’ parenteral support needs

PS daily duration 20+ hours/day Parenteral support duration for some intestinal failure patients

Market Reality Check

$1.09 Last Close

Volume Volume 148,472 is 0.51x the 20-day average of 290,006, indicating subdued trading ahead of this news. low

Technical Shares at $1.03 are trading below the 200-day MA of $3.20, about 96.9% under the 52-week high of $33.25 and 12.27% above the 52-week low of $0.9174.

Peers on Argus 2 Down

While JAGX was up 3.26% pre-announcement, momentum data show 2 Argus-tracked biotech peers (e.g., GRI, TOVX) moving down with a median move of about -5.5%, suggesting today’s crofelemer update is more stock-specific than a broad sector shift.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Jan 02	FDA grant support	Positive	+7.1%	FDA CVM grant and conditional approval renewal for Canalevia-CA1 in dogs.
Dec 15	Crofelemer trial update	Positive	-11.8%	Abstract submission and positive preliminary crofelemer SBS-IF data.
Dec 10	Conditional approval renewal	Positive	+13.7%	FDA renewal of conditional approval for Canalevia-CA1 through 2026.
Dec 08	Shareholder meeting results	Positive	+1.9%	Approval of all special meeting proposals and MVID trial progress.
Dec 02	EMA advisory request	Positive	-1.3%	EMA CVMP advice request on EU approval path for Canalevia in dogs.

Pattern Detected

Recent Jaguar headlines skew positive, but price reactions have been mixed, with both rallies and selloffs following favorable regulatory and clinical developments.

Recent Company History

Over the past months, Jaguar reported multiple regulatory and clinical milestones. FDA-related events for Canalevia-CA1, including conditional approval renewal through December 21, 2026 and a $240,000 FDA grant, saw share moves of 13.68% and 7.12%. EU-focused regulatory steps for Canalevia and royalty and financing agreements were also disclosed. Crofelemer data in SBS-IF and MVID, including PS reductions up to 37% and an FDA meeting on expedited MVID review, previously triggered both positive and negative price reactions. Today’s UAE pediatric data further extend this evolving crofelemer narrative.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-10-03

Jaguar has an effective S-3 shelf filed on October 3, 2025, with at least one usage evidenced by a 424B3 prospectus on November 25, 2025. The shelf documentation references prior private placements and unregistered warrants for 492,612 shares at an exercise price of $5.84, alongside various preferred stock designations and ownership caps such as 19.99% limits tied to certain securities.

Market Pulse Summary

The stock moved +9.7% in the session following this news. A strong positive reaction aligns with Jaguar’s pattern of sizable moves on favorable crofelemer and regulatory updates, such as prior swings of 13.68% and 7.12% on FDA-related news. The new UAE pediatric data reinforce earlier PS reduction findings up to 37%, potentially validating the orphan strategy. However, the stock trades far below its $33.25 52-week high, and the effective S-3 shelf and past financings mean capital-raising risk could influence the durability of any rally.

Key Terms

parenteral support medical

"results demonstrating parenteral support (PS) reduction ranging from 12 to 37%"

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

"which 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.

short bowel syndrome (SBS-IF) medical

"intestinal failure due to the orphan diseases short bowel syndrome (SBS-IF) and microvillus"

Short bowel syndrome with intestinal failure (SBS-IF) is a chronic medical condition in which much of the small intestine is missing or not working, so the body cannot absorb enough water, calories, and nutrients and patients often require long-term intravenous or tube feeding. Investors care because SBS-IF drives demand for specialized drugs, medical devices, long-term care services and hospital resources, so advances, approvals, or cost changes can materially affect healthcare revenue and reimbursement dynamics — like a factory losing a conveyor belt and needing new systems to keep production running.

microvillus inclusion disease (MVID) medical

"intestinal failure due to the orphan diseases short bowel syndrome (SBS-IF) and microvillus inclusion disease (MVID)"

A rare, inherited disorder that appears in infants when cells lining the small intestine lack tiny hair‑like structures (microvilli), so the gut cannot absorb fluids and nutrients; this causes severe, life‑threatening diarrhea and often requires long‑term intravenous nutrition or other intensive care. For investors, MVID signals a clear unmet medical need that can make treatments, diagnostics or medical devices attractive targets for drug developers, diagnostic labs and specialty biotech firms because of potential regulatory incentives and high per‑patient value despite a small patient population.

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 clinical trial medical

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

A placebo-controlled clinical trial tests a new treatment by comparing it to a placebo—an inactive pill or procedure—so some participants receive the experimental therapy while others receive the inert substitute, usually assigned at random and often without knowing which they have. Investors care because this design produces clearer, less biased evidence about whether a drug actually works and is safe; strong results can boost regulatory approval odds and commercial value, while negative results can sharply reduce a drug’s prospects.

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.

prevalence medical

"MVID is a devastating ultrarare pediatric disorder, with an estimated worldwide prevalence of 100-200 patients"

A measure of how common a disease, condition, or characteristic is within a defined group at a specific time, usually expressed as a percent or rate — like checking what fraction of apples in a crate are bruised. Investors use prevalence to gauge the potential size of a market, estimate demand for treatments or services, and assess regulatory and revenue implications; higher prevalence often means larger addressable markets and clearer business opportunities.

AI-generated analysis. Not financial advice.

• Article discusses results demonstrating parenteral support (PS) reduction ranging from 12 to 37% in ongoing proof-of-concept study of crofelemer in pediatric patients with intestinal failure

• Associated with significant toxicities to patients, PS has a lethal natural history, and PS reduction can potentially extend and save lives

SAN FRANCISCO, CA / ACCESS Newswire / January 6, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced that an article published December 29, 2025 in HEALTH, a bi-monthly English and Arabic healthcare magazine in the United Arab Emirates, discusses the groundbreaking results of the ongoing and independent proof-of-concept study of crofelemer in pediatric patients in the UAE with intestinal failure due to the orphan diseases short bowel syndrome (SBS-IF) and microvillus inclusion disease (MVID). As announced, the initial results of this study were presented November 8, 2025 at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting by the study's primary investigator, Dr. Mohamad Miqdady, Division Chief of the Pediatric Gastroenterology, Hepatology & Nutrition Division at Sheikh Khalifa Medical City, a tertiary care center in Abu Dhabi in the UAE. The article can be viewed by clicking here.

The initial results of the proof-of-concept trial of crofelemer in the UAE demonstrate disease progression modification through reduction of parenteral support (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 are important because PS treatment has a lethal natural history, and crofelemer can potentially extend and save the lives of patients by reducing the volume of PS.

The intestines of patients with intestinal failure due to SBS-IF and MVID are unable to function like an intact gut. 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 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.

The UAE has a significantly high prevalence of congenital disorders (birth defects) and genetic conditions, due to the frequency of consanguineous marriage. Many Arab countries display some of the highest rates of consanguineous marriages in the world, ranging around 20-50% of all marriages.

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. The ability of crofelemer to decrease the volume of parenteral support in MVID patients is potentially life extending for these patients and is thus disease progression modifying.

In addition to supporting the ongoing crofelemer study in the UAE, Jaguar family company Napo Pharmaceuticals 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. In October 2025, as announced, the company completed a meeting with the FDA in support of a possible expedited approval pathway for crofelemer for 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 crofelemer may have the potential to extend and save the lives of patients with intestinal failure due to short bowel syndrome or MVID, and 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 PS reductions did Jaguar Health (JAGX) report for crofelemer in the UAE study?

The UAE proof‑of‑concept study reported parenteral support reductions of 12–37% across reported pediatric patients.

How much did crofelemer reduce PS in the two SBS‑IF patients in the January 6, 2026 release?

The two SBS‑IF patients showed 12.5–15.6% reduction in PS at the highest dose over a 12‑week treatment period.

What PS reductions were observed in the MVID patient reported by Jaguar Health (JAGX)?

The initial MVID patient showed up to 27% PS reduction over 12 weeks and up to 37% during an extension after reinitiation.

Does crofelemer have regulatory designations that could affect JAGX's development timeline?

Yes; crofelemer has received Orphan Drug Designation from both the FDA and EMA and the company completed an FDA meeting regarding a possible expedited pathway.

Are larger trials of crofelemer underway that could impact JAGX's clinical readouts?

Yes; placebo‑controlled trials in adult SBS‑IF and pediatric MVID are ongoing in the US, EU, and Middle East, per the announcement.

What clinical safety or symptom changes were reported with crofelemer in the UAE patients?

The reported clinical effect alongside PS reduction was a reduced frequency of loose watery stools; no new safety verdicts or approval outcomes were reported.