Jaguar Health Inc Stock Price, News & Analysis

Jaguar Health (NASDAQ:JAGX) announced that the U.S. FDA has granted Orphan Drug Designation to crofelemer for microvillus inclusion disease (MVID), a rare congenital diarrheal disorder. This designation adds to crofelemer's existing orphan status for short bowel syndrome (SBS) from both the FDA and European Medicines Agency. Jaguar aims to conduct proof-of-concept studies to reduce parenteral nutritional needs in patients with SBS or CDD throughout 2023. The Orphan Drug Act offers development incentives, including tax credits and seven-year marketing exclusivity for orphan drugs.

Jaguar Health (NASDAQ:JAGX) announced a Notice of Allowance from the U.S. Patent and Trademark Office for its patent application concerning methods for treating various types of diarrhea, including Bile Acid Diarrhea and Short Bowel Syndrome.

This is a significant step toward securing a U.S. patent for crofelemer, the active ingredient in its FDA-approved drug Mytesi, which helps alleviate noninfectious diarrhea in HIV/AIDS patients on ART. Jaguar currently holds around 145 patents with protection extending until 2031 and has another 55 pending patents globally, reinforcing its position in the botanical drug market.

Jaguar Health (Nasdaq: JAGX) announced significant progress in its Phase 3 OnTarget clinical trial for crofelemer, reaching approximately 75% enrollment with 256 patients targeted for the Q2 2023 completion. The trial aims to evaluate crofelemer's efficacy in preventing diarrhea in adult cancer patients undergoing targeted therapy, a side effect that can diminish treatment adherence. The company has expanded trial sites globally, enhancing enrollment efficiency through advanced digital health technology. Crofelemer, an oral botanical drug approved by the FDA for noninfectious diarrhea in HIV/AIDS patients, represents a novel approach to tackle cancer therapy-related diarrhea.

Jaguar Health, Inc. (NASDAQ:JAGX) announced a successful closing of a private placement financing round for its subsidiary, Napo Therapeutics, achieving a fully diluted valuation of approximately €55 million. Jaguar holds around 73.5% ownership in Napo Therapeutics, which aims to expand access to its plant-based medicine, crofelemer, in Europe for rare diseases like short bowel syndrome and congenital diarrheal disorders. This financing includes an initial investment to aid in clinical development and investor engagement, with expectations of raising up to €7 million in total for this round. The funds will support various scientific and clinical initiatives in line with regulatory requirements.

Jaguar Health (NASDAQ:JAGX) announced on February 7, 2023, that it has regained compliance with Nasdaq's minimum bid price requirement. The company expressed optimism regarding two upcoming late-stage clinical events expected to enhance value recognition within the next six months. Enrollment for the OnTarget trial is projected to complete by Q2 2023. Additionally, Jaguar is focusing on a proof-of-concept trial for crofelemer related to short bowel syndrome and congenital diarrheal disorders with intestinal failure. For more information, please visit jaguar.health.

Jaguar Health (NASDAQ:JAGX) and SynWorld Technologies have mutually terminated the Canalevia Agreement, effective January 31, 2023. This agreement, initiated in June 2022, focused on the treatment of diarrhea in dogs within the Chinese market.

Jaguar is redirecting its efforts towards human drug development, specifically the OnTarget trial for cancer therapy-related diarrhea and further research on rare diseases. CEO Lisa Conte expressed that this shift aims to enhance value creation within the next six months. While both companies may explore future opportunities, geopolitical factors will influence any potential collaboration related to Canalevia.

Jaguar Health (NASDAQ:JAGX) has entered a service agreement with Shareholder Intelligence Services, LLC to track market participants and analyze share ownership data. This collaboration aims to combat illegal short selling, which can depress stock prices and harm investor interests. According to CEO Lisa Conte, this initiative is vital for maximizing shareholder value and ensuring compliance with SEC and FINRA regulations. ShareIntel's platform will assist in identifying potential illegal practices in trading, thereby promoting transparency and effective price discovery for Jaguar's stock.

Jaguar Health, Inc. (NASDAQ:JAGX) has appointed Andrew Mulberg, M.D., former FDA Deputy Director, as a regulatory consultant to enhance its regulatory strategy. Dr. Mulberg, noted for his role in approving Jaguar's crofelemer, will support the company’s focus on ongoing clinical trials, including a Phase 3 study for cancer therapy-related diarrhea. This appointment aims to leverage Dr. Mulberg's extensive regulatory expertise to facilitate future access to crofelemer, a plant-based treatment for various gastrointestinal disorders. Jaguar Health continues to develop non-opioid medicines for serious gastrointestinal conditions while ensuring sustainability in its production processes.

Jaguar Health (NASDAQ:JAGX) announced the grant of 7,500 restricted stock units (RSUs) each to two new employees, effective January 19, 2023. Post-reverse stock split on January 23, 2023, this will equal 100 RSUs per employee. The RSUs vest over three years, contingent upon continued employment. This grant was approved by the Compensation Committee as an inducement for the new hires. Jaguar Health focuses on plant-based, non-opioid medicines for gastrointestinal distress.