Jaguar Health Inc Stock Price, News & Analysis

Jaguar Health (JAGX) announced that the European Commission has granted Orphan Drug Designation to crofelemer for treating short bowel syndrome (SBS). This milestone follows the application submitted by Napo EU, Jaguar's Italian subsidiary. SBS affects 10,000 to 20,000 individuals in the U.S. and Europe. The global SBS market was valued at over $568 million in 2019 and is projected to reach $4.6 billion by 2027. Napo EU plans to initiate a pivotal clinical trial aiming for accelerated marketing authorization in Europe for crofelemer, which has received similar designation in the U.S.

Jaguar Health has presented findings from the HALT-D trial, evaluating the efficacy of crofelemer for preventing chemotherapy-induced diarrhea (CID) in HER2-positive breast cancer patients. The study involved 51 patients treated with crofelemer or standard care. While the primary endpoint showed no statistical difference in diarrhea incidence, significant improvements were noted in several secondary endpoints, including lower CID occurrence in the crofelemer group (23%). These results provide proof-of-concept data and underscore the need for effective prophylactic treatments for CID during chemotherapy.

Jaguar Health (NASDAQ:JAGX) is set to host a closed satellite event on December 9, 2021, at the San Antonio Breast Cancer Symposium (SABCS) to discuss cancer therapy-related diarrhea. The event will feature oncologists and a presentation on the ongoing OnTarget Pivotal Phase 3 trial of crofelemer, aimed at preventing diarrhea in adult cancer patients receiving targeted therapies. Data from the HALT-D trial will also be presented, evaluating crofelemer for chemotherapy-induced diarrhea in HER2-positive breast cancer patients.

Jaguar Health, Inc. (NASDAQ:JAGX) announced topline results from the Phase 2 HALT-D trial for crofelemer in preventing chemotherapy-induced diarrhea (CID) in HER2-positive breast cancer patients. The trial, involving 51 patients, saw an overall incidence of diarrhea around 70%, showing no significant difference between crofelemer and control groups. However, secondary endpoints indicated crofelemer led to a lower incidence of grade 2 or higher diarrhea compared to standard care. These results support further testing and endpoint selection for the ongoing Phase 3 OnTarget trial.

Jaguar Health reported a 7.6% increase in Mytesi prescription volume in Q3 2021, with net sales around $0.6 million. Despite a decrease in gross revenue to $3.2 million, the company is transitioning to a closed specialty pharmacy network to improve patient access. Upcoming milestones include the presentation of Phase 2 HALT-D study results and the launch of Canalevia-CA1 for dogs. The company reported a net loss of $12.2 million for Q3 2021, a significant increase from $7.9 million in Q3 2020.

Jaguar Health, Inc. (NASDAQ:JAGX) has appointed Massimo Mineo as General Manager of its Italian subsidiary, Napo EU. With over 20 years of pharmaceutical experience, Mineo will spearhead strategies for the marketing authorization of crofelemer, targeting short bowel syndrome with intestinal failure, a rare disease. His prior roles included leading commercial operations at Recordati Rare Diseases, where he successfully launched orphan drugs. The appointment is expected to strengthen Napo EU's market presence in Europe, enhancing access to crofelemer for patients in need.

Jaguar Health (NASDAQ:JAGX) announced a rescheduled investor webcast for reviewing Q3 2021 financials on November 17, 2021, at 8:30 AM ET. The change is due to additional time required for finalizing accounting aspects of the recent merger with Dragon SPAC S.p.A. and Napo EU S.p.A.

Jaguar focuses on developing plant-based medicines for GI distress, particularly targeting chronic diarrhea. Its product Mytesi is FDA-approved for relieving noninfectious diarrhea in HIV/AIDS patients on antiretroviral therapy.

Jaguar Health (NASDAQ:JAGX) will host a webcast on November 15, 2021, at 8:30 AM ET to discuss its Q3 2021 financials and provide business updates. Registration is available here. The company focuses on developing plant-based, non-opioid medications for gastrointestinal issues, including its approved product Mytesi (crofelemer), which treats noninfectious diarrhea in adults with HIV/AIDS. For further details, visit jaguar.health.

Jaguar Health, Inc. (NASDAQ:JAGX) announced the appointment of Annabella Amatulli as chief regulatory officer for its Italian subsidiary, Napo EU S.p.A. Amatulli is recognized for her expertise in global regulatory affairs, having previously worked at Dompé and Janssen Pharmaceuticals. She will focus on strategic planning for Napo EU's development programs, particularly for crofelemer, aimed at addressing unmet gastrointestinal medical needs in Europe. The company aims to expedite the drug’s marketing authorization for short bowel syndrome with intestinal failure.