Jaguar Health Receives Fee Waivers from FDA

FDA fee waivers for Mytesi and Canalevia-CA1 reduce Jaguar Health’s near-term regulatory cost burden on key crofelemer products.

Rhea-AI Summary

Jaguar Health (JAGX) and family company Napo Pharmaceuticals received U.S. Food and Drug Administration waivers of 2027 fiscal year fees for two crofelemer-based products. Napo obtained a waiver of the Prescription Drug User Fee Act (PDUFA) fee for Mytesi (crofelemer delayed-release tablets), an FDA-approved prescription drug for symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy, which is commercialized in the U.S. by Future Pak.

Jaguar separately received a 2027 fiscal year fee waiver from the FDA’s Center for Veterinary Medicine for Canalevia-CA1, its conditionally approved prescription drug for treatment of chemotherapy-induced diarrhea in dogs, also commercialized in the U.S. by Future Pak. The announcement also reiterates the Jaguar group’s broader focus on plant-derived prescription drugs for gastrointestinal and mental health indications.

Positive

• FDA PDUFA fee waiver granted for Mytesi for the 2027 fiscal year
• FDA veterinary fee waiver granted for Canalevia-CA1 for the 2027 fiscal year

Negative

• None.

Key Figures

PDUFA fee waiver: 2027 fiscal year FDA fee waiver: 2027 fiscal year

PDUFA fee waiver

2027 fiscal year

Mytesi

FDA fee waiver

2027 fiscal year

Canalevia-CA1 through the Center for Veterinary Medicine

Key Terms

pdufa, delayed-release tablets, antiretroviral therapy, conditionally approved

4 terms

pdufa regulatory

"waiver of the fee associated with the Prescription Drug User Fee Act (PDUFA)"

PDUFA is the Prescription Drug User Fee Act, the U.S. law under which drug companies pay fees that fund the FDA's review of new medicines. In company news the term usually appears as the PDUFA date, the target deadline by which the FDA aims to decide on a drug application; that date tells investors when to expect the approval or rejection decision for the product.

delayed-release tablets technical

"Mytesi® (crofelemer delayed-release tablets)"

Delayed-release tablets are pills designed to hold their active ingredient inside a protective coating that dissolves later than a standard tablet, so the medicine is released at a specific point in the digestive system rather than immediately. For investors, this matters because such formulations can improve a drug’s effectiveness, reduce side effects, extend patent value, and create commercial differentiation—similar to a time-release mechanism that makes a product work more reliably where and when it’s needed.

antiretroviral therapy medical

"adult patients with HIV/AIDS on antiretroviral therapy"

Antiretroviral therapy is a combination of medicines that suppress the replication of retroviruses, most commonly HIV, keeping the virus at low levels so the immune system can work. Think of it as a multi-part recipe that closes the taps the virus uses to multiply; it matters to investors because treatment demand, drug pricing, patent status, and new formulation approvals directly affect pharmaceutical revenues, market competition, and healthcare cost forecasts.

conditionally approved regulatory

"Jaguar's conditionally approved prescription drug"

An authorization from a regulator that allows a product to be marketed while the company still must meet specific requirements, such as providing more safety or effectiveness data, improving manufacturing, or limiting use. Think of it like a probationary driver's license: the product can start generating sales, but future revenue and the company's valuation depend on fulfilling those conditions and avoiding regulatory setbacks.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

SAN FRANCISCO, CA / ACCESS Newswire / September 22, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that the U.S. Food and Drug Administration (FDA) has granted Napo's request for a waiver of the fee associated with the Prescription Drug User Fee Act (PDUFA) for Mytesi^® (crofelemer delayed-release tablets) for the 2027 fiscal year. Mytesi is an FDA-approved prescription drug for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy, and is currently commercialized in the U.S. by Future Pak, LLC.

Jaguar was also granted a waiver of the fee by the Center for Veterinary Medicine of the FDA for the 2027 fiscal year for Canalevia^®-CA1, Jaguar's conditionally approved prescription drug for the treatment of chemotherapy-induced diarrhea in dogs, which is also commercialized in the U.S. by Future Pak, LLC.

About the Jaguar Health Family of Companies

Jaguar Health, Inc. ("Jaguar") develops novel proprietary prescription drugs sustainably derived from plants for people with complicated gastrointestinal ("GI") disease states. Jaguar family companies Napo Pharmaceuticals, Inc. and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

For more information about:

Jaguar Health, visit https://jaguar.health

Napo Pharmaceuticals, visit napopharma.com

Napo Therapeutics, visit napotherapeutics.com

Magdalena Biosciences, visit magdalenabiosciences.com

About Mytesi^®

Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. 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. 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%).

See full Prescribing Information at Mytesi.com. 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. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.

Important Safety Information About Canalevia^®-CA1

For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.

See full Prescribing Information at Canalevia.com.

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that the company will file a New Drug Application (NDA) for crofelemer for MVID in mid-2027. 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. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. 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.

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire