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Jaguar Health

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Accesswire
12 days ago
Jaguar Health Completes Meeting with FDA for Advice on Development Pathways to Advance Ongoing Crofelemer Trial for Potential Approval for Treatment of Pediatric Indication Microvillus Inclusion Disease (MVID)
Additional update: Results of ongoing investigator-initiated proof-of-concept trial in United Arab Emirates (UAE) demonstrate further reduction of total parenteral support (PS) (comprised of total parenteral nutrition and supplementary IV fluids) of approximately 37% SAN FRANCISCO, CA / ACCESS Newswire / October 6, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today provided its assessment of the company's Type C Meeting with the U.S. Food and Drug Administration (FDA) on October 2, 2025 to seek their advice for efficient advancement of the company's clinical trial of its novel crofelemer powder formulation for oral solution for the treatment of microvillus inclusion disease (MVID), an ultrarare pediatric disorder. Members of Napo's Scientific Advisory Board, including a key opinion leader who is the principial investigator for the ongoing open-label investigator-initiated trial (IIT) in the UAE, along with its other advisors, participated in this meeting.
Jaguar Health Completes Meeting with FDA for Advice on Development Pathways to Advance Ongoing Crofelemer Trial for Potential Approval for Treatment of Pediatric Indication Microvillus Inclusion Disease (MVID)
Neutral
Accesswire
18 days ago
FDA-Authorized Expanded Access Programs Utilizing Jaguar Health's Novel Crofelemer Powder for Oral Solution to Treat Two Pediatric Intestinal Failure Patients with Microvillus Inclusion Disease
The two programs are being conducted under separate Single-Patient Investigational New Drug (sIND) applications in the United States SAN FRANCISCO, CA / ACCESS Newswire / September 30, 2025 / Jaguar Health (NASDAQ:JAGX) today announced that Jaguar family company Napo Pharmaceuticals (Napo) is providing the company's novel crofelemer powder for oral solution for use in two expanded access programs, authorized by the U.S. Food and Drug Administration (FDA), to treat pediatric intestinal failure patients with microvillus inclusion disease (MVID). "Napo is committed to providing the novel crofelemer formulation as an investigational drug as deemed medically necessary by the physician caregiver for these two patients, intended for mitigating the sequela from MVID disease progression," said Pravin Chaturvedi, PhD, Napo's and Jaguar's Chief Scientific Officer and Chair of the Scientific Advisory Board.
FDA-Authorized Expanded Access Programs Utilizing Jaguar Health's Novel Crofelemer Powder for Oral Solution to Treat Two Pediatric Intestinal Failure Patients with Microvillus Inclusion Disease
Neutral
Accesswire
23 days ago
Jaguar Health Receives Notice of $250,000 FDA Grant to Fund Confirmatory Trial to Support FDA Approval of Canalevia for Treatment of Chemotherapy-Induced Diarrhea (CID) in Dogs
Company strategy: In discussions with multiple potential animal health company partners to expand the indication and commercialize Canalevia for treatment of general diarrhea globally SAN FRANCISCO, CA / ACCESS Newswire / September 25, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar"), under its Jaguar Animal Health tradename for the veterinary market, today announced that it has received notice from the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) of a $250,000 grant. Canalevia, under the name Canalevia-CA1, is currently conditionally approved for chemotherapy-induced diarrhea (CID) in dogs.
Jaguar Health Receives Notice of $250,000 FDA Grant to Fund Confirmatory Trial to Support FDA Approval of Canalevia for Treatment of Chemotherapy-Induced Diarrhea (CID) in Dogs
Neutral
Accesswire
24 days ago
Jaguar Health Submits Orphan Drug Designation Application to FDA for Crofelemer for Cancer Therapy-Related Diarrhea (CTD) in Patients with Breast Cancer with Metastasis Identified by FDA as a Distinct Condition
Potential treatment for patients with breast cancer with metastasis to the brain with crofelemer would augment the significant responder analysis results for crofelemer in the prespecified subgroup of patients with breast cancer from the OnTarget study that were reported at the Multinational Association of Supportive Care in Cancer 2025 Annual Meeting and the 2024 San Antonio Breast Cancer Symposium SAN FRANCISCO, CA / ACCESS Newswire / September 24, 2025 / Jaguar Health (NASDAQ:JAGX) today announced that Jaguar family company Napo Pharmaceuticals (Napo) has submitted an orphan drug designation (ODD) application to the U.S. Food and Drug Administration (FDA) for crofelemer, the company's novel prescription drug, for the treatment of diarrhea in adult patients with breast cancer that has metastasized to the brain receiving targeted therapy with or without standard chemotherapy. Within the last ten years, the FDA's Office of Orphan Products Development (OOPD) has publicly acknowledged that brain metastasis of any cancer is considered a disease or condition separate and distinct from the primary site of origin.
Jaguar Health Submits Orphan Drug Designation Application to FDA for Crofelemer for Cancer Therapy-Related Diarrhea (CTD) in Patients with Breast Cancer with Metastasis Identified by FDA as a Distinct Condition
Neutral
Accesswire
25 days ago
Jaguar Health Presenting September 25 at Emerging Growth Conference and September 30 at Lytham Partners Fall 2025 Conference to Provide Updates on Near-Term Catalysts
SAN FRANCISCO, CA / ACCESS Newswire / September 23, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that Lisa Conte, the company's founder, president and CEO, will present virtually on Thursday, September 25, 2025 at the Emerging Growth Conference and virtually on Tuesday, September 30, 2025 at the Lytham Partners Fall 2025 Conference. Participation Instructions for Jaguar's Virtual Presentation at the Emerging Growth Conference When: Thursday, September 25, 2025 from 2:55 - 3:05 PM Eastern Time Where: Online (Click Here) Registration link for conference: Click Here Replay: An archived webcast of the presentation will be made available on EmergingGrowth.com and on the Emerging Growth YouTube Channel.
Jaguar Health Presenting September 25 at Emerging Growth Conference and September 30 at Lytham Partners Fall 2025 Conference to Provide Updates on Near-Term Catalysts
Neutral
Accesswire
1 month ago
Jaguar Health Presenting at September 8-10 H.C. Wainwright Annual Global Investment Conference to Provide Updates on Near-Term Catalysts
Click here to register SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / September 5, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that Lisa Conte, the company's founder, president and CEO, will present virtually at the H.C. Wainwright 27th Annual Global Investment Conference, which takes place September 8-10, 2025.
Jaguar Health Presenting at September 8-10 H.C. Wainwright Annual Global Investment Conference to Provide Updates on Near-Term Catalysts
Neutral
Accesswire
1 month ago
Jaguar Health Participating in August 25-26 Animal Health Summit with Goal of Securing Collaboration to Expand Canalevia's Indication to Treatment of General Diarrhea in Dogs
Canalevia® (crofelemer delayed-release tablets), under the name Canalevia®-CA1 , is conditionally approved by the FDA for treatment of CID in dogs Company strategy: In discussions with multiple potential animal health company partners to expand the indication and commercialize Canalevia for treatment of general diarrhea globally Diarrhea is one of the most common reasons owners bring their dog to the veterinarian and the second most common reason for visits to the veterinary emergency hospital, yet there are currently no FDA-approved drugs to treat general diarrhea in dogs Enrollment has reached approximately 25% in Jaguar's ongoing field study of Canalevia-CA1 in dogs SAN FRANCISCO, CA / ACCESS Newswire / August 21, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar"), under its Jaguar Animal Health tradename for the veterinary market, today announced it is participating in the 2025 Animal Health Summit in support of the company's goal of securing a collaboration to expand the indication of Canalevia (crofelemer delayed-release tablets) from treatment of chemotherapy-induced diarrhea (CID) in dogs to treatment of general diarrhea in dogs. Canalevia, under the name Canalevia-CA1, is conditionally approved by the U.S. Food and Drug Administration (FDA) for treatment of CID in dogs.
Jaguar Health Participating in August 25-26 Animal Health Summit with Goal of Securing Collaboration to Expand Canalevia's Indication to Treatment of General Diarrhea in Dogs
Neutral
Accesswire
2 months ago
Jaguar Health Reports Approval of All Proposals at August 2025 Annual Meeting of Stockholders
Jaguar CEO Lisa Conte presenting August 20 at Emerging Growth Conference to provide updates on near-term catalysts; Click here to register As announced , initial proof-of-concept results from the ongoing investigator-initiated trial in Abu Dhabi show crofelemer reduced the required total parenteral nutrition in the first participating microvillus inclusion disease (MVID) patient by up to 27% and in the first participating short bowel syndrome (SBS-IF) patient by up to 12.5%; FDA meeting resulted in planned Jaguar regulatory pathway to complete supplemental NDA strategy for crofelemer for patients with metastatic breast cancer, a population meeting orphan definition in US Company strategy: Seek business development partnerships for license to develop and commercialize Jaguar's orphan indication products, resulting in non-dilutive funding for Jaguar SAN FRANCISCO, CA / ACCESS Newswire / August 19, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today announced the voting results of the Company's Annual Meeting of Stockholders held on August 19, 2025 (the "Annual Meeting"). Seven proposals were submitted to and approved by the stockholders of the Company at the Annual Meeting.
Jaguar Health Reports Approval of All Proposals at August 2025 Annual Meeting of Stockholders
Neutral
Seeking Alpha
2 months ago
Jaguar Health, Inc. (JAGX) Q2 2025 Earnings Call Transcript
Jaguar Health, Inc. (NASDAQ:JAGX ) Q2 2025 Earnings Conference Call August 14, 2025 8:30 AM ET Company Participants Carol R. Lizak - Chief Financial Officer Lisa A.
Jaguar Health, Inc. (JAGX) Q2 2025 Earnings Call Transcript
Neutral
Accesswire
2 months ago
Jaguar Health Family Company Napo Pharmaceuticals to Meet with FDA to Discuss Potential Regulatory Pathways for Crofelemer for Treatment of Ultrarare Pediatric Indication Microvillus Inclusion Disease (MVID)
As announced , initial proof-of-concept results from the ongoing investigator-initiated trial in Abu Dhabi show crofelemer reduced the required total parenteral nutrition in the first participating MVID patient by up to 27%; abstract describing results accepted for presentation at upcoming North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) 2025 Annual Meeting in Chicago SAN FRANCISCO, CA / ACCESS Newswire / August 19, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that it plans to meet with the U.S. Food and Drug Administration (FDA) to discuss the company's ongoing clinical development program for crofelemerfor the treatment of microvillus inclusion disease (MVID), an ultrarare pediatric disorder. Members of Napo's Scientific Advisory Board will join Napo and Jaguar representatives at the meeting.
Jaguar Health Family Company Napo Pharmaceuticals to Meet with FDA to Discuss Potential Regulatory Pathways for Crofelemer for Treatment of Ultrarare Pediatric Indication Microvillus Inclusion Disease (MVID)