Jaguar Health, Inc. - JAGX STOCK NEWS

Jaguar Health (NASDAQ:JAGX) has initiated a Phase 2 study to evaluate crofelemer, its plant-based prescription drug, for Microvillus Inclusion Disease (MVID) in pediatric patients. This study is part of five clinical efforts, including three proof-of-concept trials and two Phase 2 studies, across US, EU, and MENA regions. The first patient dosing is expected between December 2024 and January 2025, with initial results potentially available in Q1 2025.

Crofelemer has received Orphan-Drug Designation from both FDA and EMA for MVID and SBS-IF. The study will evaluate a novel oral powder solution formulation, different from the FDA-approved Mytesi® tablets. MVID is an ultrarare pediatric disease affecting approximately 200 patients globally, characterized by severe diarrhea and malabsorption, with no currently approved treatments.

Jaguar Health (NASDAQ:JAGX) announced that the FDA has granted orphan-drug designation (ODD) to crofelemer for treating diarrhea in cholera patients. This plant-based prescription drug previously received Phase 2 data from clinical trials in Bangladesh. The ODD provides development incentives including tax credits and a seven-year marketing exclusivity period if approved.

Crofelemer is currently involved in five rare disease clinical trials, with patient dosing expected throughout December 2024 and Q1 2025. Results could be available by Q2 2025. The company also plans to pursue ODD for a second-generation agent, NP-300, along with a Tropical Disease Priority Review Voucher, which historically has sold for $67-350 million.

Cholera affects 1.3-4 million cases globally annually, with 21,000-143,000 deaths. WHO has classified the global cholera resurgence as a grade 3 emergency, its highest internal level.

Ladenburg Thalmann is hosting a Scientific Showcase webinar on December 18, 2024, focusing on Jaguar Health's (NASDAQ:JAGX) clinical development of crofelemer, their plant-based anti-diarrheal drug. The event will highlight five ongoing clinical efforts for rare disease indications: three proof-of-concept investigator-initiated trials and two Phase 2 studies targeting microvillus inclusion disease (MVID) and short bowel syndrome with intestinal failure (SBS-IF) across US, EU, and Middle East/North Africa regions. Initial proof-of-concept results are expected in Q2 2025. The company also announced that Massimo Radaelli, CEO of Napo Therapeutics and President of Jaguar International, was named 'Best Pharmaceuticals Innovator of the Year - Europe' by The European publication.

Jaguar Health (NASDAQ:JAGX) announced significant positive results from its Phase 3 OnTarget trial evaluating crofelemer for cancer therapy-related diarrhea (CTD) in breast cancer patients. The trial included 183 breast cancer patients out of 287 total participants. 47.1% of patients receiving crofelemer were responders through 12 weeks, compared to 33.7% in the placebo group, showing statistically significant improvement in diarrhea control.

The study revealed that among breast cancer patients on abemaciclib, over 43% required dose reduction or termination due to diarrhea, while all patients on pertuzumab-based therapies needed dose adjustments. Napo Pharmaceuticals plans to submit these results to the FDA to discuss pathways for making crofelemer available to breast cancer patients.

Jaguar Health (NASDAQ:JAGX) announced that data from their Phase 3 OnTarget trial's breast cancer subgroup analysis will be presented at the San Antonio Breast Cancer Symposium (SABCS) on December 11, 2024. The presentation will highlight significant results of crofelemer for Cancer Therapy-Related Diarrhea (CTD) in breast cancer patients, who formed the majority of trial participants.

While the initial OnTarget study did not meet its primary endpoint across all tumor types, the breast cancer subgroup showed promising outcomes. The company plans to submit these findings to the FDA to discuss potential pathways for making crofelemer available to breast cancer patients. A full study report will be submitted to a peer-reviewed journal.

A second poster presentation focusing on the trial's placebo arm data will also be featured at SABCS, which expects over 10,000 attendees.

Jaguar Health (NASDAQ:JAGX) announced the commencement of a U.S. Investigator-Initiated Trial (IIT) to evaluate crofelemer, their plant-based anti-diarrheal drug, for Short Bowel Syndrome with Intestinal Failure (SBS-IF). This study is part of five clinical efforts, including three IIT proof-of-concept studies and two Phase 2 studies across US, EU, and MENA regions.

The trials will evaluate a novel powder formulation of crofelemer for oral solution, with patient dosing expected throughout December 2024 and Q1 2025. Initial IIT proof-of-concept results could be available in Q2 2025. Notably, crofelemer has received Orphan Drug Designation from both FDA and European Medicines Agency for SBS-IF and Microvillus Inclusion Disease (MVID).

Jaguar Health's prescription drug Canalevia-CA1 for treating chemotherapy-induced diarrhea (CID) in dogs has been featured in PetVet Magazine. The drug, which contains crofelemer as its active ingredient, is the first and only FDA-conditionally approved treatment for CID in dogs.

Canalevia-CA1 is a canine-specific formulation derived from the Croton lechleri tree. The drug addresses a significant health concern, as cancer therapy-related diarrhea can impact treatment effectiveness and may require dosing adjustments or discontinuation of cancer medications. The same active ingredient is being studied in Jaguar's Phase 3 OnTarget trial for cancer therapy-related diarrhea in humans.

Jaguar Health (NASDAQ:JAGX) is attending the Pet Connect conference from December 3-5, 2024, seeking partnerships for NP300, their novel prescription drug candidate for treating general, non-infectious diarrhea in dogs. NP300 shares similar mechanisms with Canalevia-CA1, their FDA conditionally approved drug for chemotherapy-induced diarrhea in dogs. The company estimates 6 million annual cases of acute and chronic diarrhea in U.S. veterinary visits. Despite diarrhea being one of the most common reasons for veterinary visits and the second most common cause for emergency room visits, there are currently no FDA-approved drugs for general canine diarrhea. The drug is derived from the Croton lechleri tree and has demonstrated safety in dogs.

Jaguar Health (NASDAQ:JAGX) has announced two upcoming presentations by CEO Lisa Conte. The first will be an in-person presentation at NobleCon20 on December 3, 2024, from 10:30-10:55 AM EST at Florida Atlantic University. The second will be a virtual presentation at the Emerging Growth Conference on December 5, 2024, from 10:50-11:20 AM EST. Both presentations will be available for replay, with NobleCon20's webcast archived for 90 days on their website and Channelchek platform.