Jaguar Health Inc Stock Price, News & Analysis

Jaguar Health (NASDAQ:JAGX) has announced an upcoming investor webcast scheduled for Wednesday, November 13, 2024, at 8:30 AM Eastern Time. The webcast will review the company's third-quarter 2024 financial results and provide corporate updates. The company plans to file its Q3 2024 Earnings Report on Form 10-Q for the quarter ended September 30, 2024. A replay of the webcast will be available on Jaguar's investor relations website section.

Jaguar Health (NASDAQ:JAGX) announced FDA approval renewal for Canalevia-CA1, their prescription drug treating chemotherapy-induced diarrhea (CID) in dogs. The renewal extends conditional approval until December 21, 2025. Canalevia-CA1, a canine-specific formulation of crofelemer derived from the Croton lechleri tree, remains the first and only FDA-approved treatment for CID in dogs. The company is progressing toward full FDA approval through an agreed-upon clinical field study design. The drug is currently available through major U.S. veterinary distributors, including Chewy.

Jaguar Health (NASDAQ:JAGX) announced that a late-breaking abstract showing significant results for crofelemer in breast cancer patients from the Phase 3 OnTarget trial has been accepted for presentation at the San Antonio Breast Cancer Symposium (SABCS) on December 11, 2024. The analysis focuses on breast cancer patients, who formed the majority of participants in this prophylactic trial studying cancer therapy-related diarrhea in adult patients with solid tumors. A second late-breaking abstract based on the trial's placebo arm data will also be presented. The company plans to use these findings to discuss potential pathways with the FDA for making crofelemer available to breast cancer patients.

Jaguar Health (NASDAQ:JAGX) announced positive results from two independent investigator-initiated studies of crofelemer, presented at the American College of Gastroenterology Annual Scientific Meeting. The first study showed that crofelemer significantly decreased stool consistency and abdominal pain in patients with functional diarrhea. The second study demonstrated that 58.8% of patients with chronic idiopathic diarrhea improved within a 4-week treatment period. Both studies suggest crofelemer's effectiveness in treating different forms of chronic diarrhea, with minimal side effects. The drug has also shown promise in previous Phase 2 trials for IBS-D and achieved statistical significance in breast cancer patients from the Phase 3 OnTarget trial.

Jaguar Health (NASDAQ:JAGX) has launched Gelclair, an FDA-approved oral mucositis prescription product, in the U.S. This marks Jaguar's third commercialized prescription product and initiates its commercial footprint in cancer supportive care. Gelclair is a gel that adheres to the mouth's mucosal surface, providing rapid and long-lasting pain relief without stinging or numbing.

Oral mucositis, affecting up to 90% of head and neck cancer patients treated with chemotherapy and radiotherapy, is a significant adverse event in oncology. It can lead to treatment interruptions and hospitalization. Jaguar's launch strategy includes a dedicated team of representatives and plans to exhibit at key oncology conferences.

Jaguar Health (NASDAQ:JAGX) has announced new employee inducement grants under Nasdaq Listing Rule 5635(c)(4). Effective October 7, 2024, the company granted restricted stock units (RSUs) to five new employees. New Employee 1 received 80,000 RSUs, which will vest equally over three years, with one-third of the shares vesting each year from the date of hire. New Employees 2-5 each received 15,000 RSUs, which will vest over one year from their respective hire dates.

These RSU grants were approved by Jaguar's Compensation Committee as an inducement for the employees to accept employment with the company. The vesting of the RSUs is contingent on each new employee's continued service with Jaguar through the applicable vesting dates.

Magdalena Biosciences, a joint venture between Jaguar Health and Filament Health, is set to present at the BIO Investor Forum on October 16, 2024. Dr. Karen Brunke, Jaguar's EVP and Acting CEO of Magdalena, will provide an overview of the company's progress in developing novel, natural prescription medicines for mental health indications.

Magdalena's lead botanical drug candidate, MB2500, is expected to be IND-enabled soon for attention deficit hyperactivity disorder (ADHD) and potentially for cognitive deficit in schizophrenia. The company aims to submit an Investigational New Drug (IND) application to the FDA in early 2025, with 1-2 additional IND applications planned for the same year.

MB2500 is derived from a well-characterized plant with neuroprotective and cognitive enhancing properties. Magdalena is focusing on advancing plant-based innovations for mental health conditions, targeting the $25 billion global ADHD market and the growing schizophrenia market, projected to reach $13.41 billion by 2032.

Jaguar Health (NASDAQ:JAGX) has submitted a late-breaking abstract for a first-of-kind study evaluating the impact of diarrhea from cancer therapies in breast cancer patients who received placebo in its OnTarget Phase 3 trial. The study analyzed data from 142 patients with solid tumors, including nearly 75 breast cancer patients receiving targeted therapies with or without standard chemotherapy.

The abstract focuses on the incidence, severity, and management of cancer therapy-related diarrhea (CTD) based on patient-reported outcomes (PROs) collected through digital applications. This marks the first time that the natural history of gastrointestinal symptoms from targeted therapies and/or chemotherapy has been reported directly by patients throughout a CTD study.

Napo Pharmaceuticals, a Jaguar family company, is continuing to analyze data from the OnTarget trial and plans further discussions with the FDA. The study aims to provide insights into cancer therapy dose modifications necessitated by CTD and emphasizes the importance of patient-centric studies in providing appropriate supportive care for adult patients with solid tumors.

Jaguar Health (NASDAQ:JAGX) has reported statistically significant improvement in breast cancer patients in its Phase 3 OnTarget trial for crofelemer, a cancer supportive care drug. The trial evaluated crofelemer for prophylaxis of cancer therapy-related diarrhea. Breast cancer patients accounted for nearly 180 of the 287 participants in this prophylactic clinical trial.

While the initial top line results did not meet the primary estimand for all tumor types, the subgroup analysis in adult breast cancer patients showed clinically meaningful improvement. This suggests crofelemer's potential to help breast cancer patients better adhere to their cancer therapies. The results have been submitted to a relevant oncology conference, and a full study report is expected to be submitted to a peer-reviewed journal.

Additionally, crofelemer has shown benefit in patients with diarrhea-predominant irritable bowel syndrome (IBS-D), with results to be presented at the upcoming American College of Gastroenterology Annual Scientific Meeting.