Jaguar Health (JAGX) Stock News

Jaguar Health (NASDAQ:JAGX) has established the first study site for its field study of Canalevia-CA1, an FDA conditionally approved prescription drug for treating chemotherapy-induced diarrhea (CID) in dogs. The company has two main objectives: obtaining full FDA approval for CID treatment and expanding the drug's indication to treat general, non-infectious diarrhea in dogs. Jaguar is actively seeking partners to fund development and commercialization of the drug for the broader diarrhea indication. The market opportunity is significant, with approximately 6 million annual cases of acute and chronic diarrhea in dogs seen by U.S. veterinarians. The prospective, randomized, open-label field study will collect real-world data on Canalevia-CA1's effectiveness in dogs undergoing chemotherapy. Currently, there are no FDA-approved drugs for treating general diarrhea in dogs, despite it being one of the most common reasons for veterinary visits.

Jaguar Health (NASDAQ:JAGX) announces a virtual fireside chat featuring CEO Lisa Conte on June 10, 2025, at 9:00 AM ET as part of Lytham Partners' Spring 2025 Spotlight Series. The discussion will center on the company's recent FDA meeting regarding statistically significant responder analysis results from their Phase 3 OnTarget trial's breast cancer patient subgroup. The company notes that the US metastatic breast cancer population potentially qualifies as an orphan population, aligning with their core focus. Jaguar Health plans to pursue authorization for an expanded access program for breast cancer patients who may not qualify for a potential pivotal treatment trial with crofelemer in metastatic breast cancer patients.

Jaguar Health (NASDAQ:JAGX) reports a productive Type C Meeting with the FDA regarding crofelemer for cancer therapy-related diarrhea (CTD) in metastatic breast cancer patients. The company proposed two pathways: conducting a pivotal treatment trial and initiating an expanded access program. While the Phase 3 OnTarget trial didn't meet its primary endpoint overall, the breast cancer patient subgroup (183 of 287 participants) showed statistically significant improvement in diarrhea response compared to placebo. The company plans to pursue orphan drug designation, as the US metastatic breast cancer population qualifies as an orphan population. Jaguar also intends to seek Breakthrough Therapy and/or Fast Track designation. Crofelemer has been previously commercialized for HIV-related diarrhea since 2012 with no reported serious adverse events.

Jaguar Health (NASDAQ:JAGX) has announced that its founder, president and CEO Lisa Conte will participate in a virtual fireside chat on June 10, 2025, at 9:00 AM Eastern. The event is part of Lytham Partners' Spring 2025 Spotlight Series and will focus on the company's efforts to advance its orphan disease development programs. The one-hour virtual discussion will be available for replay after the event for those unable to attend the live session.

Jaguar Health (NASDAQ:JAGX) has announced a $1.5 million registered direct offering priced at-the-market. The company will sell 246,306 shares of common stock at $6.09 per share. Additionally, in a concurrent private placement, Jaguar will issue unregistered warrants to purchase up to 492,612 shares at an exercise price of $5.84 per share, exercisable immediately and expiring within 24 months.

H.C. Wainwright & Co. serves as the exclusive placement agent. The offering is expected to close around May 22, 2025. Jaguar plans to use the net proceeds for general corporate purposes, including growth capital, working capital, operating expenses, repayment of outstanding convertible promissory notes, and capital expenditures.

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.