Jaguar Health Inc Stock Price, News & Analysis

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.

Jaguar Health (NASDAQ:JAGX) announced significant results from their Phase 3 OnTarget study focusing on Mytesi (crofelemer) for cancer therapy-related diarrhea. The study's prespecified subgroup analysis of breast cancer patients showed statistically significant results, despite the trial not meeting its primary endpoint across all tumor types.

The company has secured a Type C Meeting with the FDA in Q2 2025 to discuss potential approval pathways for crofelemer in breast cancer patients. The trial included 183 breast cancer patients out of 287 total participants. The results will be presented at the MASCC Annual Meeting in Seattle (June 26-28, 2025).

Additionally, a second late-breaker abstract on oral mucositis in cancer patients has been accepted for presentation at the same MASCC meeting, highlighting the company's broader focus on cancer supportive care.

Napo Pharmaceuticals, a Jaguar Health company (NASDAQ:JAGX), is showcasing Gelclair, their FDA-approved oral mucositis prescription product, at the Oncology Nursing Society Congress in Denver. Gelclair represents the company's third commercialized prescription product and marks their expansion into cancer-related supportive care.

Gelclair is a protective gel that provides pain relief for oral mucositis ('chemo mouth'), a common side effect affecting up to 40% of chemotherapy patients and 90% of head and neck cancer patients receiving chemo and radiotherapy. The product uniquely offers soothing relief without stinging or burning effects.

The company's core target audiences are head and neck cancer patients (71,110 US cases in 2024) and bone marrow transplant patients (approximately 23,000 annually). Notably, oral mucositis has been identified as the most significant adverse event in oncology by the National Comprehensive Cancer Network task force, with 19% of head and neck cancer patients requiring hospitalization due to high-grade mucositis.

Jaguar Health (NASDAQ:JAGX) has announced new employee inducement grants effective April 3, 2025. The company granted restricted stock units (RSUs) to six new employees: two employees received 3,600 RSUs each with three-year vesting periods, while four employees received 600 or 100 RSUs each with one-year vesting schedules.

Additionally, the company granted incentive stock options to a seventh employee for the purchase of up to 520 shares at an exercise price of $4.55 per share. These options vest 25% after nine months and monthly thereafter over 36 months. All grants were approved by Jaguar's Compensation Committee and are subject to continued employment.