Jaguar Health Inc Stock Price, News & Analysis

Jaguar Health (NASDAQ:JAGX) has received regulatory clearance from Italian and German health authorities for a Phase 2 study of crofelemer in adults with Short Bowel Syndrome with Intestinal Failure (SBS-IF). The study, initiated on February 18, 2025, is part of five clinical efforts including three proof-of-concept trials and two Phase 2 studies for SBS-IF and microvillus inclusion disease (MVID).

The company expects the first proof-of-concept results potentially in H1 2025, with additional results throughout the year. Crofelemer, a plant-based anti-secretory prescription drug, has received Orphan-Drug Designation from both FDA and EMA for SBS-IF and MVID. These rare diseases affect approximately 10,000 to 20,000 people each in both the US and Europe, requiring intensive parenteral nutrition and significantly impacting patient quality of life.

Jaguar Health (NASDAQ:JAGX) and Napo Pharmaceuticals have extended their collaboration with Streeterville until January 2026 for developing NP-300, targeting cholera treatment and pursuing a Tropical Disease Priority Review Voucher (TDPRV). The FDA's TDPRV Program is currently the only active PRV program, potentially increasing voucher values which historically sold for up to $350 million.

NP-300 is a proprietary botanical extract distinct from crofelemer but with the same mechanism of action, sustainably derived from the Croton lechleri tree. The development targets cholera, which causes 1.3 to 4 million cases and 21,000 to 143,000 deaths annually worldwide. From January to July 2024, 307,433 cholera cases and 2,326 deaths were reported across 26 countries, leading WHO to classify it as a grade 3 emergency.

Jaguar Health (NASDAQ:JAGX) has announced that its founder, president and CEO Lisa Conte will deliver a virtual presentation at the Emerging Growth Conference on Tuesday, February 18, 2025, from 3:55 - 4:05 PM Eastern Standard Time. The presentation will be accessible online, and an archived webcast will be available on EmergingGrowth.com and the Emerging Growth YouTube Channel for those unable to attend live.

Magdalena Biosciences, a joint venture between Jaguar Health (NASDAQ:JAGX) and Filament Health, plans to present at the BIO CEO & Investor Conference on February 10, 2025. The company is developing their lead botanical drug candidate, MB2500, targeting cognitive deficit in schizophrenia or executive dysfunction in ADHD.

The company aims to submit an Investigational New Drug (IND) application to the FDA in 2025, with 1-2 additional applications planned for late 2025/early 2026. MB2500 is derived from a well-characterized plant with historical use and demonstrated neuroprotective and cognitive enhancing properties.

Magdalena targets the $25 billion global ADHD market and the schizophrenia market, projected to reach $13.41 billion by 2032. The company, approximately 40% owned by Jaguar Health, expects to progress from plant extract to proof-of-concept human studies in 12-24 months, potentially offering a new class of plant-based psychoactive drugs suitable for daily dosing.

Jaguar Health (NASDAQ:JAGX) has announced the dosing of the first short bowel syndrome with intestinal failure (SBS-IF) patient in an investigator-initiated pediatric proof-of-concept trial of crofelemer, their plant-based antidiarrheal prescription drug. The trial is being conducted at Sheikh Khalifa Medical City in Abu Dhabi.

This follows the dosing of the first microvillus inclusion disease (MVID) patient two weeks ago in the same trial. The study is part of five clinical efforts for crofelemer in rare diseases, including three proof-of-concept studies and two Phase 2 studies across the US, EU, and MENA regions.

Proof-of-concept data, potentially available in H1 2025, could lead to reimbursed early patient access in certain European countries. Both SBS-IF and MVID are rare diseases requiring intensive parenteral nutrition. SBS affects approximately 10,000-20,000 people in both the US and Europe, while MVID has an estimated global prevalence of a few hundred patients.

Jaguar Health (NASDAQ:JAGX) has filed a provisional patent application with the USPTO for crofelemer to address gastrointestinal side effects associated with GLP-1 and other weight loss therapies. Crofelemer, FDA-approved under the brand name Mytesi for HIV-related diarrhea, has shown significant benefits in improving GI symptoms including diarrhea, abdominal pain, and bloating.

The application targets the growing market of GLP-1 therapies, projected to reach $56 billion globally by 2025 and grow at a 21% CAGR to $322 billion by 2034. GI disorders are reported in 40-70% of patients using GLP-1 receptor agonists, with rates up to 85% in some cases, often leading to dose limitations or discontinuations.

Jaguar Health (NASDAQ:JAGX) announced the first patient dosing in an investigator-initiated proof-of-concept (POC) trial evaluating crofelemer for Microvillus Inclusion Disease (MVID) at Sheikh Khalifa Medical City in UAE. The trial, led by Dr. Mohamad Miqdady, will also include pediatric patients with short bowel syndrome with intestinal failure (SBS-IF).

This study is one of five clinical efforts for crofelemer in rare diseases, with POC data potentially available in H1 2025. Positive results could lead to reimbursed early patient access in certain European countries. Crofelemer has received Orphan Drug Designation from both FDA and European Medicines Agency for MVID and SBS-IF.

MVID affects a few hundred patients globally, while SBS affects 10,000-20,000 people in both the U.S. and Europe. Pediatric SBS incidence varies between 0.02% to 1.2% of live births, with a maximal U.S. incidence estimated at approximately 43,000 based on 2023 birth rates.

Jaguar Health (NASDAQ:JAGX) has announced the granting of restricted stock units (RSUs) to three new employees, effective January 8, 2025. The company issued 15,000 RSUs each to two employees and 45,000 RSUs to a third employee. For the first two employees, the RSUs will vest over one year from their respective hire dates, while the third employee's RSUs will vest equally over three years, with one-third vesting annually. These grants were approved by Jaguar's Compensation Committee as inducement material for employment acceptance and require continued service with the company through applicable vesting dates.

Jaguar Health (NASDAQ:JAGX) has announced two upcoming investor presentations. CEO Lisa Conte will participate in a virtual fireside chat at the Lytham Partners 2025 Investor Healthcare Summit on January 13, 2025, at 12:00 PM EST, with replay available. Additionally, the company will deliver an in-person presentation at the Biotech Showcase on January 14, 2025, at 3:00 PM PST at the Hilton San Francisco - Union Square in the Yosemite A track.