Jaguar Health Inc Stock Price, News & Analysis

Jaguar Health (NASDAQ:JAGX) has announced the randomization of the first patient in their Phase 2 clinical trial evaluating crofelemer for pediatric patients with Microvillus Inclusion Disease (MVID). Initial proof-of-concept results from an ongoing investigator-initiated trial in Abu Dhabi showed promising outcomes, with crofelemer reducing total parenteral support by up to 27% in a pediatric MVID patient. The patient's symptoms worsened when taken off the treatment, leading to early reinstatement. The company expects additional proof-of-concept results throughout 2025, with Phase 2 study results anticipated in H2 2026. Given MVID's ultrarare status, positive results even in a small number of patients could potentially lead to expedited approval through the EU's PRIME program and FDA's Breakthrough Therapy designation. Currently, there are no approved drug treatments for MVID, a condition requiring life-sustaining total parenteral nutrition.

Jaguar Health (NASDAQ:JAGX) reported Q1 2025 financial results with combined net revenue of $2.2 million, showing a 6% decrease from Q1 2024 ($2.4M) and a 37% decline from Q4 2024 ($3.5M). While Mytesi prescription volume increased by 1.8% YoY, it decreased 13.5% QoQ. The company's net loss widened to $10.4 million compared to $9.2 million in Q1 2024. Key operational highlights include proof-of-concept results showing crofelemer reduced total parenteral nutrition in MVID and SBS-IF patients by up to 27% and 12.5%. R&D expenses decreased by $0.6M to $3.7M, while Sales & Marketing expenses increased by $1.1M to $2.5M. The company's non-GAAP Recurring EBITDA loss increased to $9.7 million from $8.8 million in Q1 2024.

Jaguar Health (NASDAQ:JAGX) has announced an upcoming investor webcast scheduled for Thursday, May 15, 2025, at 4:15 PM Eastern Time. The company will use this webcast to review its first-quarter 2025 financial results and provide corporate updates. The company plans to file its Form 10-Q earnings report for the quarter ended March 31, 2025, on May 15, 2025.

Jaguar Health (NASDAQ:JAGX) is highlighting its role in pet cancer care during National Pet Cancer Awareness Month. The company's FDA conditionally approved drug Canalevia®-CA1 is the first and only treatment for chemotherapy-induced diarrhea (CID) in dogs. According to statistics, approximately 1 in 4 dogs develop cancer in their lifetime, with nearly 50% of dogs over age 10 affected. The National Cancer Institute reports about 6 million new cancer diagnoses in dogs annually in the U.S. Canalevia-CA1, a canine-specific formulation of crofelemer derived from the Croton lechleri tree, is available through Chewy and veterinarians nationwide by prescription. The company also runs the "Make Cancer Less Shitty" advocacy program to address supportive cancer care needs.

Jaguar Health (NASDAQ:JAGX) has outlined key 2025 catalysts for crofelemer, their FDA-approved plant-based drug. Initial proof-of-concept results for crofelemer in pediatric patients with intestinal failure showed promising outcomes: TPN reduction of up to 27% in MVID and 12.5% in SBS-IF patients. The drug also demonstrated improvements in stool volume, watery stool frequency, and urine output. For their Cancer Therapy-Related Diarrhea program, while the Phase 3 OnTarget trial missed its primary endpoint across all tumor types, significant results were observed in the breast cancer subgroup (183 of 287 participants). The FDA has granted a Type C Meeting in Q2 2025 to discuss these breast cancer-specific results. Additional data will be presented at the MASCC Annual Meeting in June 2025.

Jaguar Health announced promising proof-of-concept results for their drug crofelemer in treating rare intestinal diseases. The study showed crofelemer reduced total parenteral nutrition (TPN) requirements by up to 27% in patients with Microvillus Inclusion Disease (MVID) and by 12.5% in those with Short Bowel Syndrome (SBS-IF).

The trial, presented at the Annual ELITE PED-GI Congress, demonstrated reduced stool volume output and increased urine output, indicating improved nutrient absorption. Dr. Mohamad Miqdady, Chief of Pediatric Gastroenterology at Sheikh Khalifa Medical City, led this open-label study of crofelemer's novel liquid formulation.

Notably, when a pediatric MVID patient discontinued crofelemer after 12 weeks, symptoms worsened within 8 days, leading to treatment reinstatement. The company is pursuing expedited regulatory pathways through EMA's PRIME program and FDA's Breakthrough Therapies program, given the significant unmet need in treating these rare conditions.

Jaguar Health has announced an upcoming investor webcast on April 30, 2025, at 8:30 AM Eastern to present initial results from a proof-of-concept study of crofelemer. The study focuses on two rare diseases: Microvillus Inclusion Disease (MVID) and Short Bowel Syndrome with Intestinal Failure (SBS-IF).

The data was recently presented by Dr. Mohamad Miqdady at the 11th Annual ELITE PED-GI Congress in Abu Dhabi. The webcast will cover:

• Patient experience with MVID and SBS-IF
• Impact of crofelemer on disease progression
• Quality of life improvements
• Potential expedited regulatory pathways for MVID treatment

Notably, MVID is an ultrarare pediatric condition characterized by severe diarrhea and malabsorption, currently with no approved drug treatments. The study utilizes a novel liquid formulation of crofelemer, Jaguar's plant-based anti-secretory prescription drug.

Jaguar Health (NASDAQ:JAGX) has announced an upcoming investor webcast on April 30, 2025, to present initial results from a proof-of-concept study of crofelemer, their plant-based anti-secretory prescription drug. The study focuses on treating Microvillus Inclusion Disease (MVID) and Short Bowel Syndrome with Intestinal Failure (SBS-IF).

The preliminary results were presented by Dr. Mohamad Miqdady at the 11th Annual ELITE PED-GI Congress in Abu Dhabi. The webcast will feature key opinion leaders including Dr. Miqdady, Dr. Christos Tzivinikos, and Dr. Pravin Chaturvedi.

Jaguar is currently conducting multiple studies: three proof-of-concept investigator-initiated trials and two placebo-controlled Phase 2 studies across the United States, European Union, and Middle East/North Africa regions. Additional proof-of-concept results are expected throughout 2025, potentially supporting early patient access to crofelemer in EU countries.

Jaguar Health (NASDAQ:JAGX) announced that preliminary results from an ongoing pediatric trial of crofelemer, their plant-based anti-secretory drug, will be presented at the April 2025 ELITE PED-GI Congress in Abu Dhabi. The study focuses on treating microvillus inclusion disease (MVID) and short bowel syndrome with intestinal failure (SBS-IF).

Crofelemer has received Orphan Drug Designation from both FDA and EMA for these conditions. The proof-of-concept study evaluates crofelemer's potential to improve stool formation, enhance nutrient absorption, and reduce total parenteral nutrition (TPN) needs in patients. Currently, there are no approved drug treatments for MVID, an ultrarare pediatric disease characterized by severe diarrhea.

Positive results could potentially qualify crofelemer for the EMA's PRIME program and FDA's Breakthrough Therapies program, expediting development and review processes. The study is being conducted at Sheikh Khalifa Medical City under Dr. Mohamad Miqdady's leadership.