Jaguar Health, Inc. - JAGX STOCK NEWS

Jaguar Health, Inc. (NASDAQ:JAGX) announced the publication of the HALT-D trial results in the journal Breast Cancer Research and Treatment. The study evaluated crofelemer, a plant-based antidiarrheal, for preventing chemotherapy-induced diarrhea (CID) in HER2-positive breast cancer patients. CID affects up to 80% of these patients, leading to hospitalization in some cases. While crofelemer is currently in a Phase 3 trial for adult patients with solid tumors, the HALT-D trial results are significant for addressing CID, a debilitating side effect of cancer treatments.

Jaguar Health has received Orphan Drug Designation (ODD) for crofelemer to treat Microvillus Inclusion Disease (MVID) in the EU. This designation follows the earlier ODD granted for short bowel syndrome (SBS). The designation enhances the potential for expanded patient access to crofelemer in Europe, with expected clinical data presentations planned for December 2022. Additionally, Pravin Chaturvedi of Jaguar was honored at the Boston Biotechnology Summit for his contributions to the pharmaceutical industry.

Jaguar Health, under its Jaguar Animal Health tradename, is co-sponsoring the Closing Ceremony at the Veterinary Cancer Society Annual Conference on October 15, 2022. The event aims to promote the Take C.H.A.R.G.E. initiative, a national cancer registry for dogs, which tracks cancer incidence and prevalence. This free registry currently holds nearly 36,000 patient records and 830 confirmed diagnoses, providing valuable data to veterinarians. Additionally, Jaguar is showcasing its FDA conditionally approved product, Canalevia-CA1, for treating chemotherapy-induced diarrhea in dogs.

Jaguar Health (NASDAQ:JAGX) announced that all four proposals were approved at its 2022 Special Meeting of Stockholders held on September 30, 2022. Detailed information about these proposals can be found in the Company's definitive proxy statement filed with the Securities and Exchange Commission on August 29, 2022. The Company focuses on developing plant-based, non-opioid medicines for gastrointestinal distress in humans and animals. Jaguar Health is also engaged in ongoing clinical trials for its crofelemer drug product.

Napo Pharmaceuticals, a subsidiary of Jaguar Health (NASDAQ:JAGX), has received FDA activation for its Investigational New Drug (IND) application for NP-300, aimed at treating moderate-to-severe diarrhea due to cholera and other pathogens. This approval positions Napo to initiate a phase I clinical trial, following which it can progress to the next stages of development. NP-300, derived from Croton lechleri, could qualify for a Tropical Disease Priority Review Voucher, potentially yielding significant revenue upon approval. Cholera impacts millions globally, highlighting the drug's importance.

Jaguar Health, Inc. (NASDAQ:JAGX) announced that CEO Lisa Conte will present at the virtual Lytham Partners Fall 2022 Investor Conference on September 28, 2022, participating in a panel on orphan drugs. Conte expressed optimism regarding the potential clinical advancements for short bowel syndrome and congenital diarrheal diseases. Additionally, Jaguar will present at the Ladenburg Thalmann 2022 Healthcare Conference on September 29, 2022. The company focuses on therapies for rare diseases, with a significant emphasis on their crofelemer product.

Jaguar Health (NASDAQ:JAGX) announced the IND application submission for NP-300, aimed at treating diarrhea from cholera. This initiative follows their prior Phase 2 findings on crofelemer, which shares a similar mechanism. The company plans to pursue a Tropical Disease Priority Review Voucher post-approval, which has previously commanded values up to $350 million. Jaguar is also focusing on pivotal clinical trials, including a Phase 3 trial for cancer therapy-related diarrhea, expected to complete enrollment by mid-2023. The cholera indication aligns with significant global health needs.

Jaguar Health, Inc. (NASDAQ:JAGX) announced a royalty interest purchase agreement with Streeterville Capital, securing $4.0 million. This capital will support the ongoing pivotal Phase 3 OnTarget trial of crofelemer for preventing diarrhea in adults undergoing cancer treatment. Streeterville will receive three times the royalty purchase price from future sales royalties and milestone payments. Jaguar anticipates key development milestones within the next 6-12 months, including expediting enrollment in the OnTarget trial and a proof-of-concept study for short bowel syndrome (SBS).

Jaguar Health (NASDAQ:JAGX) announced that the FDA accepted its orphan drug designation application for crofelemer to treat Microvillus Inclusion Disease (MVID), a rare genetic disorder affecting newborns. A response is expected by the end of September 2022. In Q2 2022, Mytesi net revenue reached approximately $2.9 million, a 12% increase from Q1 2022 and a 641% rise from Q2 2021. The company credits improved revenue to a shift to a closed network of specialty pharmacies. Napo Therapeutics submitted a similar application to the EMA, focusing on expanding crofelemer access in Europe.