Our Mytesi® (crofelemer) product is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy and the only oral plant-based prescription medicine approved under FDA Botanical Guidance. Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. As previously announced, the Company is exploring the conditional marketing authorization regulatory pathway in Europe to support development and commercialization of crofelemer for the proposed indication of prophylaxis and/or symptomatic relief of inflammatory diarrhea, initially to be studied in a long-hauler COVID-19 recovery patient population in Europe. Napo is pursuing the development of Mytesi to treat cancer therapy-related diarrhea in humans. According to a November 1, 2020 Wall Street Journal article, the majority of the more than 300 long-COVID patients being seen at New York City's Mount Sinai Health System Center for Post-Covid Care appeared to have developed a dysautonomia-like condition, and about 40% to 50% of these patients also reported symptoms such as gastrointestinal issues, headaches and shortness of breath2. Voucher (PRV) from the FDA, which shortens review time for an NDA. The terms long-hauler and "chronic COVID" refer to COVID-19 survivors who suffer with symptoms which may include gastrointestinal distress (i.e., diarrhea, constipation, nausea, pain), fatigue, brain fog, forgetfulness, cardiovascular effects, and arthritis, for an extended period after recovery. A significant proportion of patients undergoing cancer therapy experience diarrhea. * JAGUAR HEALTH - ON APRIL 7, FDA NOTIFIED CO THAT IT WAS DECLINING TO ISSUE AN EUA FOR CROFELEMER AT THIS TIME BRIEF-Jaguar Health Inc Files For Non Timely 10-K … Rule out infectious etiologies of diarrhea before starting Mytesi®. FDA Invites Jaguar Health to Expedite Submission of Regulatory Filing for Approval of Canalevia (Crofelemer) to Treat Chemotherapy-induced Diarrhea in Dogs JAGX has an FDA approved organic treatment (Crofelemer/Mytesi) that is being used to treat HIV with the potential to treat multiple health issues including COVID-19, cancer, cholera, and psychological disorders, increasing sales revenue quarter over quarter. "Based on the MOU, we anticipate providing an exclusive license to Napo EU for the development, manufacture and commercialization of all planned crofelemer indications in Europe (excluding Russia), which rights and obligations shall be assumed by the combined company following a merger of Napo EU with the Dragon SPAC. Site contains links to information about post-COVID-19 ‘long-hauler' syndrome, An article published yesterday in the San Francisco Chronicle references diarrhea as long-hauler symptom and the theory that the type of inflammation associated with HIV may also be present in long-hauler patients, Napo EU to explore conditional marketing authorization for proposed inflammatory diarrhea indication for crofelemer, initially in long-hauler COVID-19 recovery patients in Europe. SAN FRANCISCO, CA / ACCESSWIRE / February 9, 2021 / Jaguar Health, Inc. (NASDAQ:JAGX) announced today that noted natural products industry veteran Dr. Nigel Gericke has joined the scientific strategy team (SST) for the company's recently launched mental health Entheogen Therapeutics Initiative (ETI), which aims to discover and develop groundbreaking, novel, natural medicines derived from psychoactive plants for treatment of mood disorders, neurodegenerative diseases, addiction, and other mental health disorders. These include statements regarding the expectation that additional content will be added to the Napo EU website soon, the belief that GI symptoms in long-hauler COVID patients may also be related to inflammation, and thus analogous to GI symptoms observed in people who have lived with HIV/AIDS for a long period of time, and the belief that crofelemer's mechanism of action has the potential to benefit multiple disorders. For more information about Napo, visit www.napopharma.com. Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). ABC serves the public, researchers, educators, healthcare professionals, industry and media, and has been a highly respected source and an innovative force for many years. here to unlock and sign up to a 14-day FREE TRIAL, Jaguar Health Launches Website for Napo EU, https://www.accesswire.com/631273/Jaguar-Health-Launches-Website-for-Napo-EU, Jaguar Health Announces Commitment to Move Forward with Exclusive Relationship with the Planned Dragon SPAC, which is Pursuing Listing on AIM Italia and Plans to Target Napo EU, https://www.accesswire.com/630801/Jaguar-Health-Announces-Commitment-to-Move-Forward-with-Exclusive-Relationship-with-the-Planned-Dragon-SPAC-which-is-Pursuing-Listing-on-AIM-Italia-and-Plans-to-Target-Napo-EU, Jaguar Health Signs Memorandum of Understanding with the Lead Sponsor of the Planned Dragon SPAC Pursuing Listing on AIM Italia, Providing the Dragon SPAC with Exclusivity for a Proposed Business Combination with Napo EU, https://www.newsbreak.com/news/2104072336660/dr-fauci-warns-these-covid-symptoms-can-last-for-months, https://www.msn.com/en-us/health/health-news/doctors-begin-to-crack-covid-s-mysterious-long-term-effects/ar-BB1aAS6V, https://www.accesswire.com/630448/Jaguar-Health-Signs-Memorandum-of-Understanding-with-the-Lead-Sponsor-of-the-Planned-Dragon-SPAC-Pursuing-Listing-on-AIM-Italia-Providing-the-Dragon-SPAC-with-Exclusivity-for-a-Proposed-Business-Combination-with-Napo-EU, Noted Natural Products Industry Veteran Dr. Nigel Gericke Joins Scientific Strategy Team for Jaguar Health's Recently Launched Mental Health Entheogen Therapeutics Initiative, https://www.accesswire.com/628409/Noted-Natural-Products-Industry-Veteran-Dr-Nigel-Gericke-Joins-Scientific-Strategy-Team-for-Jaguar-Healths-Recently-Launched-Mental-Health-Entheogen-Therapeutics-Initiative, Jaguar Health's Chief of Sustainable Supply, Dr. Steven King, an Ethnobotanist, to Discuss Crofelemer Development on February 4th at 2 PM Eastern as Part of the American Botanical Council's Sustainable Herbs Program Webinar Series, https://www.accesswire.com/627522/Jaguar-Healths-Chief-of-Sustainable-Supply-Dr-Steven-King-an-Ethnobotanist-to-Discuss-Crofelemer-Development-on-February-4th-at-2-PM-Eastern-as-Part-of-the-American-Botanical-Councils-Sustainable-Herbs-Program-Webinar-Series, View All In addition to pursuing an indication for CID in dogs, Jaguar is also seeking conditional approval to market Canalevia for exercise-induced diarrhea (EID) in dogs. These include statements regarding the Company's expectation that Dr. King will take part in the ABC webinar on February 4, 2021. Site contains links to information about post-COVID-19 ‘long-hauler' syndrome. Crofelemer (Mytesi®), Napo's commercialized antidiarrheal drug, is FDA-approved in the U.S. for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. The SST consists of leading and globally renowned ethnobotanists, physicians, and pharmacologists, as well as experts in the fields of natural product chemistry and neuropharmacology. EVERYONE BUY 50 shares here. Mood disorders and neurodegenerative diseases affect hundreds of millions of people around the globe and represent classic unmet medical needs. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Dr. King is an ethnobotanist who has conducted field research on the use of plants for food and medicine in the highland and lowland regions of South America, Africa and parts of Southeast Asia over the past 42 years. Certain statements in this press release constitute "forward-looking statements." Certain statements in this press release constitute "forward-looking statements." FDA Invites Jaguar Health to Expedite Submission of Regulatory Filing for Approval of Canalevia (Crofelemer) to Treat Chemotherapy-induced Diarrhea in Dogs ACCESSWIRE +10.35% Jul … "Napo EU will serve as the foundation of the Company's efforts to address the growing burden - particularly in Europe - of the inflammatory diarrhea associated with long-hauler syndrome in the post COVID-19 patient population," stated Lisa Conte, Jaguar's founder, president, and CEO. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. FDA Calendar contains dates for FDA Approval PDUFA decisions, Advisory Committee and clinical trial catalysts and various financial data of biotech stocks. Jaguar Health Inc. (NASDAQ:JAGX) traded lower after announcing the approval of its education program, ‘Diarrhea in Foals’ for veterinarians and Veterinary Technicians. Mytesi® (crofelemer delayed release tablets) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances, or otherwise. JAGX stock is up on news that Jaguar Health just signed a royalty deal that will allow the company to pursue new FDA approvals.More From InvestorPlace Why … "The AOI section is one of two ‘minor' technical sections required as part of this application. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. Keep your ear to the ground with our FREE newsletter including our watch list, weekly review and daily updates These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. "We are thrilled and honored that Dr. Gericke - a highly respected veteran of the natural products industry - has joined the ETI scientific strategy team. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity. Federal government websites often end in .gov or .mil. AzurRx BioPharma Inc. (AZRX) is up more than 12% at $1.09 in pre-market hours on no news. Contact:Peter HodgeJaguar Health, Inc.[email protected]Jaguar-JAGX, Napo EU continues to explore conditional marketing authorization for proposed inflammatory diarrhea indication for crofelemer, initially in ‘long-hauler' covid-19 recovery patients in Europe. Dr. Gericke is also a longtime advocate of ecological sustainability, social responsibility, and the need to recognize Indigenous rights. This ongoing webinar series features online conversations about key issues around sustainability and the botanical industry with leaders in the botanical community. More information and complete Prescribing Information are available at Mytesi.com. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status 02/01/2021 DOCEFREZ NDA #022534 SUPPL-12 DOCETAXEL SUN PHARMA GLOBAL Labeling The scientific strategy team for Jaguar's Entheogen Therapeutics Initiative is comprised of the following members: "Jaguar is thrilled to be leading this effort to potentially uncover a pipeline of novel psychoactive plant-based compounds, engage with recognized leaders in this space, and share our findings with potential corporate partners with the goal of developing plant-based compounds into possible medical breakthroughs," said Lisa Conte, Jaguar's president, and CEO. Jaguar also seeking approval to market Canalevia for exercise-induced diarrhea in dogs. These include statements related to the belief that the expertise, experience, and commitment of the ETI SST will play an instrumental role in advancing the initial goal of identifying plants in the company's plant library that may have the potential to treat mood disorders and neurodegenerative diseases, such as schizophrenia and other forms of psychosis, Alzheimer's disease, Parkinson's disease, and amyotrophic sclerosis, the belief that psychedelic and psychoactive compounds derived from plants have significant potential for treating mental and neurological disorders and addressing other unmet mental health needs, and the belief that the same competencies and multi-disciplinary scientific strategy that led to the development of crofelemer will support collaborative efforts to discover and develop novel first-in-class prescription medicines derived from psychoactive plants. "I am delighted to have joined the ETI scientific strategy team and look forward to collaborating with the other team members as we work to discover novel therapies for managing mental health conditions from psychoactive plants that have been utilized by traditional healers for centuries. Forward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." The final approval for Tlando will be given when the exclusivity period previously granted to rival product Jatenzo, developed by … I believe psychedelic and psychoactive compounds derived from plants have significant potential for treating mental and neurological disorders and addressing other unmet mental health needs," said Dr. Gericke. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. The forward-looking statements in this release are only predictions. Jaguar Health In MoU With Dragon SPAC As Its Subsidiary Seeks Approval For Crofelemer In Europe Jaguar Health Inc (NASDAQ: JAGX) has signed a Memorandum of Understanding (MoU) … Click, Chronic Idiopathic Diarrhea in Non-HIV Patients. https://www.newsbreak.com/news/2104072336660/dr-fauci-warns-these-covid-symptoms-can-last-for-months, 2"Doctors Begin to Crack Covid's Mysterious Long-Term Effects", Sarah Toy, Sumathi Reddy, Daniela Hernandez, Wall Street Journal, November 1, 2020. https://www.msn.com/en-us/health/health-news/doctors-begin-to-crack-covid-s-mysterious-long-term-effects/ar-BB1aAS6V, Peter HodgeJaguar Health, Inc.[email protected]Jaguar-JAGX, Team of advisors guides strategic research to discover and develop potential novel, natural psychoactive prescription medicines derived from Jaguar's library of 2,300 plants, SAN FRANCISCO, CA / ACCESSWIRE / February 9, 2021 / Jaguar Health, Inc. (NASDAQ:JAGX) announced today that noted natural products industry veteran Dr. Nigel Gericke has joined the scientific strategy team (SST) for the company's recently launched mental health Entheogen Therapeutics Initiative (ETI), which aims to discover and develop groundbreaking, novel, natural medicines derived from psychoactive plants for treatment of mood disorders, neurodegenerative diseases, addiction, and other mental health disorders. "We are so pleased to be working with the Dragon SPAC and an experienced leader like Josh Mailman. ABC works to achieve this by educating end-users and industry about the issues involved and by sharing best practices to inspire more companies to implement higher standards of sustainability. It is theorized that these symptoms may result when the immune system in COVID-19 survivors continues to overreact even though the infection has passed. Lets show them what we can do together !!! If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy, and their disease may worsen. The Dragon SPAC is a newly formed initiative expected to be incorporated in Italy, with lead sponsorship by Josh Mailman. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. "While we remain steadfastly focused on the commercial success of Mytesi and on the development of crofelemer follow-on indications, we believe the same competencies and multi-disciplinary scientific strategy that led to the development of crofelemer will support collaborative efforts to discover and develop novel first-in-class prescription medicines derived from psychoactive plants.". JAGX Stock Price News: Jaguar Health Inc skyrockets as it prepares for FDA approval 01-11 fxstreet.com - 1 - NASDAQ:JAGX has had an eventful start to 2021 as the micro-cap biotech firm has already surged by over 266% in the Jaguar Health (NASDAQ: JAGX) gains FDA approval to market Canalevia (crofelemer delayed-release tablets), an oral plant-based prescription … Shares of the company fell 6.2% in Tuesday’s trading The forward-looking statements in this release are only predictions. The filing consists of the All Other Information (AOI) technical section of Jaguar's application for conditional approval of Canalevia for CID under the Minor Use/Minor Species (MU/MS) section of The Minor Use and Minor Species Animal Health Act of 2004. They await approval from the FDA’s Center of Veterinary Medicine on their oral plant-based drug candidate. The SST consists of leading and globally renowned ethnobotanists…. 1"Dr. Fauci Warns These COVID Symptoms Can Last for Months", Alex Korab, Newsbreak. Crofelemer is in a pivotal Phase 3 trial in the U.S. for the indication of cancer therapy related-diarrhea and under development for diarrhea in a "long-hauler" COVID recovery patient population in Europe. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. "Napo's discovery efforts were founded 30 years ago to identify and develop novel plant-based drugs by leveraging the knowledge of traditional healers working in rainforest areas," Mailman stated. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. For more information about Jaguar, please visit https://jaguar.health. "Long-hauler syndrome has been generating a great deal of coverage over the past several months in major media around the globe," stated Lisa Conte, Jaguar's founder, president, and CEO. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. FDA Invites Jaguar Health to Expedite Submission of Regulatory Filing for Approval of Canalevia (Crofelemer) to Treat Chemotherapy-induced Diarrhea in Dogs ACCESSWIRE Jul 20, 2020 08:30 AM EDT Canalevia would be first and only FDA-approved plant-based medicine for the more than 50,000 dogs that suffer from diarrhea during chemotherapy Josh is well-known for his integrity, and his investment values and skill set align with those of Jaguar, Napo, and Napo EU, and our mission," said Conte. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%). The company's leading drug, Mytesi, has been approved by the FDA. Although this filing was originally scheduled for submission by the end of August 2020, the CVM recently requested that the Company expedite the filing. The terms "long-hauler" and "chronic COVID" refer to COVID-19 survivors who suffer with symptoms which may include gastrointestinal distress (i.e., diarrhea, constipation, nausea, pain), fatigue, brain fog, forgetfulness, cardiovascular effects, and arthritis, for an extended period after recovery. Revenue-Generating Biopharma With an FDA-Approved Drug. Jaguar Health - Pharmaceuticals company (JAGX) Is up 1000% this month and 50% today. Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, plant-based, sustainably derived gastrointestinal products on a global basis. Canalevia would be first and only FDA-approved plant-based medicine for the more than 50,000 dogs that suffer from diarrhea during chemotherapy SAN FRANCISCO, CA / ACCESSWIRE / August 18, 2020 / Jaguar Health, Inc. (NASDAQ:JAGX) announced today that it has submitted to the U.S. During the webinar, Dr. King will discuss the long-term sustainable harvesting program for Croton lechleri (Euphorbiaceae) that he and his colleagues in several Andean countries developed in collaboration with local and Indigenous communities and regional scientists, and review the ongoing efforts of the Jaguar and Napo teams to work with international partners and Indigenous and local communities to conserve biological diversity, recognize intellectual property rights, and meet global human health care needs. Jaguar's wholly owned subsidiary, Napo Pharmaceuticals, Inc. ("Napo"), currently markets another form of crofelemer, Mytesi®, the only non-opioid oral plant-based medicine approved by the FDA for the treatment of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. He is a medical doctor, an ethnobotanist, and ethnopharmacologist, a former advisory panelist to the United States Pharmacopoeia (an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines), a longstanding member of the Medicinal Plants Specialist Group of the World Wide Fund For Nature, and a founding member of the Association for African Medicinal Plants Standards. JAGX stock is lower by -95.65% over the last 12 … SAN FRANCISCO, CA / ACCESSWIRE / January 22, 2021 / Jaguar Health, Inc. (NASDAQ: JAGX) ("Jaguar" or the "Company") announced today that effective December 9, 2020, the Company granted nonstatutory stock options for the purchase of up to 1,500 shares of the Company's common stock to one new employee, and nonstatutory stock options for the purchase of up to 35,000 shares of … Peter HodgeJaguar Health, Inc.phodge@jaguar.healthJaguar-JAGX, View source version on accesswire.com: https://www.accesswire.com/597886/FDA-Invites-Jaguar-Health-to-Expedite-Submission-of-Regulatory-Filing-for-Approval-of-Canalevia-Crofelemer-to-Treat-Chemotherapy-induced-Diarrhea-in-Dogs, https://www.accesswire.com/597886/FDA-Invites-Jaguar-Health-to-Expedite-Submission-of-Regulatory-Filing-for-Approval-of-Canalevia-Crofelemer-to-Treat-Chemotherapy-induced-Diarrhea-in-Dogs. Ticker: JAGX documents---0.00079703330993652 Jaguar Health, Inc. is registered with the U.S. Security and Exchange Commission and incorporated in the state of Delaware. For more information about Napo, visit www.napopharma.com. The mission of ABC's Sustainable Herbs Program is to create a movement supporting high quality herbal products, sustainable and ethical sourcing, and greater overall transparency in how herbs reach end users. Spread the word comon guys, dont let us be fooled bye shorts. The Resources page of the site contains links to an assortment of third-party information about post-COVID long-hauler syndrome, as well as the challenges posed in Europe and elsewhere by vaccine distribution programs, vaccine skepticism, and the appearance of more transmissible mutated strains of SARS-CoV-2, the virus that causes COVID-19. Our Mytesi® (crofelemer) product is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy and the only oral plant-based prescription medicine approved under FDA Botanical Guidance. (Note that access to the article requires a subscription to the San Francisco Chronicle). About the American Botanical CouncilEstablished in 1988, the American Botanical Council (ABC) is the leading independent, nonprofit, international member-based organization providing education using science-based and traditional information to promote the responsible use of herbal medicine. Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). SAN FRANCISCO, CA / ACCESSWIRE / February 3, 2021 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today announced that Steven King, PhD, Jaguar's chief sustainable supply, ethnobotanical research and intellectual property officer, will discuss crofelemer development on February 4, 2021 from 2 PM to 3 PM Eastern Time as part of the American Botanical Council's Sustainable Herbs Program webinar series. It is estimated that as high as one-third1 of COVID-19-infected patients develop chronic or chronic episodic long-hauler syndrome - a constellation of post-viral infection symptoms. "We believe Canalevia will be an important treatment option for dogs that suffer from CID. Rule out infectious etiologies of diarrhea before starting Mytesi. Our Mytesi® (crofelemer) product is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy and the only oral plant-based prescription medicine approved under FDA Botanical Guidance. The title of the February 4th webinar is The Development of Crofelemer: Connecting Ethnobotany, Conservation, Biocultural Diversity, Indigenous Knowledge and Global Public Health. The article references diarrhea as a symptom of long-hauler syndrome, and the theory that the type of inflammation associated with HIV may also be present in long-hauler patients. As Jaguar announced yesterday, the Company has signed a Memorandum of Understanding (the "MOU") with Josh Mailman, the lead sponsor of the Dragon SPAC, which is pursuing listing on AIM Italia.
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