Jaguar Health, Inc. - JAGX STOCK NEWS

Jaguar Health (NASDAQ:JAGX) announced the appointment of Dr. Kelly Shanahan to its Scientific Advisory Board on March 23, 2023. Dr. Shanahan is a former clinician and a metastatic breast cancer patient advocate, bringing a unique perspective to the company's focus on cancer therapy-related diarrhea (CTD). She emphasized the importance of patient comfort and the development of crofelemer, a drug targeting CTD. The OnTarget Phase 3 clinical trial for crofelemer is expected to complete patient enrollment in Q2 2023, potentially paving the way for a significant advancement in supportive care for cancer patients.

Jaguar Health, Inc. (NASDAQ:JAGX) announces an investor webcast on March 27, 2023, at 8:30 AM EDT to discuss Q4 2022 financial results and corporate updates. The company will also file its Annual Report on March 24, 2023 for the fiscal year ending December 31, 2022. Jaguar Health specializes in developing plant-based medications for gastrointestinal distress, with a focus on its candidate, crofelemer, which is undergoing a Phase 3 clinical trial for cancer patients experiencing diarrhea.

Jaguar Health announced the development of an AI-powered web portal to assist U.S. healthcare professionals with patient access to Mytesi (crofelemer), its FDA-approved drug for noninfectious diarrhea in HIV/AIDS patients. The initiative aims to mitigate access and reimbursement issues, specifically the burdensome prior authorization process. A recent AMA survey indicates that 88% of physicians face challenges with prior authorizations, which often delays patient care. By leveraging AI technology, Jaguar hopes to streamline this process and improve medication adherence, ultimately enhancing patient outcomes without collecting any Protected Health Information.

Jaguar Health (NASDAQ:JAGX) announced that its founder and CEO, Lisa Conte, will present at the BioTrinity 2023 conference in London on April 25, 2023. The presentation will focus on crofelemer, an oral botanical drug developed for short bowel syndrome (SBS) and congenital diarrheal disorders (CDD), which has received orphan drug designation from both the FDA and EMA. The event aims to raise awareness about rare diseases affecting millions globally. Jaguar's efforts aim to enhance crofelemer access in Europe through its subsidiary Napo Therapeutics.

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.