Jaguar Health Awarded $240,000 FDA Grant in Support of Canalevia-CA1 for Treatment of Chemotherapy-Induced Diarrhea (CID) in Dogs

Rhea-AI Summary

Jaguar Health (NASDAQ:JAGX) announced it received a $240,000 grant from the FDA Center for Veterinary Medicine on January 1, 2026 to support its Canalevia-CA1 effectiveness study for chemotherapy-induced diarrhea (CID) in dogs.

Canalevia-CA1 is conditionally approved for CID and the FDA renewed that conditional approval for a fifth and final year through December 21, 2026. Jaguar must complete and file a successful effectiveness study to obtain full veterinary drug approval for CID.

Positive

• $240,000 FDA grant awarded on January 1, 2026
• Conditional approval renewed through December 21, 2026

Negative

• Full approval contingent on completing and filing a successful effectiveness study
• Conditional approval is in its fifth and final year, deadline Dec 21, 2026

Key Figures

FDA grant amount $240,000 Grant supporting Canalevia-CA1 CID effectiveness study in dogs

U.S. dog population 90 million dogs Estimated number of dogs in the U.S. in 2024

Dogs with diarrhea (U.S.) 11 million dogs Estimated annual cases of general diarrhea in U.S. dogs

European dog population 104 million dogs Estimated number of dogs in Europe in 2022

Conditional approval renewal Through December 21, 2026 Fifth and final year of conditional approval for Canalevia-CA1 CID in dogs

Current share price $0.9312 Latest price before news; near 52-week low of $0.9174

52-week high $33.25 Current price is significantly below this prior level

S-3 usage count 1 filing Number of 424B supplements tied to active S-3 shelf

Market Reality Check

$1.03 Last Close

Volume Volume 169,744 vs 20-day average 297,618 (relative volume 0.57), indicating below-average trading activity. low

Technical Shares at 0.9312, trading below 200-day MA of 3.26 and just above 52-week low of 0.9174 (vs high 33.25).

Peers on Argus 1 Down

Sector peers show mixed moves: QNRX up 7.93%, ONCO up 6.85%, while XRTX down 6.33% and GRI down 12.05%, indicating stock-specific rather than broad sector momentum.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 15	Clinical data update	Positive	-11.8%	Preliminary crofelemer data in SBS-IF and MVID with reduced parenteral support.
Dec 10	FDA renewal	Positive	+13.7%	FDA renewed conditional approval of Canalevia-CA1 for CID in dogs to 2026.
Dec 08	Shareholder meeting	Positive	+1.9%	All proposals approved; highlighted crofelemer data and expedited-pathway discussions.
Dec 02	EU pathway update	Positive	-1.3%	Submission to EMA for scientific advice on Canalevia for general dog diarrhea.
Nov 24	Patent issuance	Positive	+5.0%	New Australian patent for crofelemer in short bowel and related diarrhea.

Pattern Detected

Recent news has been mostly positive, with 3 price moves aligning with positive catalysts and 2 diverging.

Recent Company History

Over the past months, Jaguar reported patent progress, EMA engagement for Canalevia in EU dogs, shareholder approvals, and orphan‑focused crofelemer data, alongside FDA renewal of conditional approval for Canalevia‑CA1 through Dec 21, 2026. Price reactions were mixed: strong gains of 13.68% on the renewal, but an 11.85% drop after positive SBS‑IF data. Today’s FDA grant for Canalevia‑CA1 fits the ongoing strategy to secure full approval and expand veterinary indications.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-10-03

Jaguar has an effective S-3 shelf registration dated Oct 3, 2025, with at least one usage evidenced by a 424B3 prospectus filed on Nov 25, 2025. This framework allows the company to register and facilitate offerings or resales, as reflected in registered shares tied to preferred stock exchanges and pre-funded warrants.

Market Pulse Summary

The stock moved +7.1% in the session following this news. A strong positive reaction aligns with Jaguar’s pattern of meaningful moves on FDA-related updates, such as the prior 13.68% gain after conditional renewal. The $240,000 FDA grant directly supports the effectiveness study needed for full Canalevia‑CA1 approval, extending an established regulatory path. However, shares trade far below the 33.25 52‑week high and the company maintains an effective S-3 shelf, factors that could influence how durable any rally proves.

Key Terms

chemotherapy-induced diarrhea medical

"Canalevia-CA1 is currently conditionally approved for chemotherapy-induced diarrhea (CID)"

Chemotherapy-induced diarrhea is a common side effect of cancer drugs where patients experience frequent, loose bowel movements that can be severe enough to require medical care or dose changes. It matters to investors because it affects patient quality of life, can force treatment delays or lower drug use, and creates demand for supportive therapies or label warnings — similar to how a recurring maintenance problem can reduce a car’s reliability and sales.

conditional approval regulatory

"the FDA granted renewal of the conditional approval for Canalevia-CA1 for a fifth and final year"

Conditional approval is a formal confirmation that a product or plan is permitted to proceed, provided certain specified requirements are met within a designated timeframe. For investors, it signals that approval is nearly complete but depends on the fulfillment of specific conditions, which could influence the final outcome or timeline. This status helps stakeholders assess the likelihood of success while identifying any remaining hurdles.

Center for Veterinary Medicine regulatory

"from the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM)"

A Center for Veterinary Medicine is the regulatory office that evaluates and oversees the safety and effectiveness of medicines, medical devices, and food additives for animals. Think of it as a gatekeeper that decides which animal health products can be sold and under what rules; those decisions shape market access, product labeling, approval timelines, and the risk of recalls, all of which directly affect a company’s sales prospects and investor value.

non-infectious diarrhea medical

"no FDA-approved drug to treat general, non-infectious diarrhea in dogs"

Non-infectious diarrhea is frequent, loose bowel movements caused by internal causes—such as medications, food intolerances, digestive diseases, or immune reactions—rather than by bacteria, viruses, or parasites. For investors, it matters because such side effects can affect clinical trial outcomes, trigger safety warnings, alter drug labeling or market demand for treatments, and influence regulatory decisions and a product’s commercial prospects; think of it like a plumbing system running too fast from an internal fault rather than an outside clog.

antibiotics medical

"The overuse and misuse of antibiotics, both in humans and animals, contribute"

Antibiotics are medicines that kill or stop the growth of bacteria, acting like targeted tools that clear bacterial infections while leaving human cells largely unharmed. Investors care because antibiotics drive sales, influence hospital and outpatient treatment patterns, and face unique risks—such as regulatory approval hurdles, shrinking effectiveness from resistance, and stewardship policies—that can shorten a drug’s commercial life and affect company revenue and valuation.

dehydration medical

"Devastating diarrhea-related dehydration can occur rapidly for the animal"

Dehydration is the loss of more water and salts from the body than are taken in, impairing organs' ability to work properly and causing symptoms from mild thirst and fatigue to serious confusion or fainting. Investors should care because dehydration influences healthcare usage, drug and device trial outcomes, product demand, and workplace productivity — much like a car running low on coolant, a dehydrated body performs poorly and can change market needs and regulatory scrutiny.

AI-generated analysis. Not financial advice.

SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / January 2, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that it received notice from the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) on January 1, 2026 that the company has been awarded a $240,000 grant. Canalevia-CA1 is currently conditionally approved for chemotherapy-induced diarrhea (CID) in dogs. The grant will support Jaguar's ongoing study for the treatment of CID in dogs.

"As announced on December 10, 2025, the FDA granted renewal of the conditional approval for Canalevia-CA1 for a fifth and final year, through December 21, 2026, for the treatment of CID in dogs. In order to receive a full veterinary drug approval for the indication of CID, Jaguar must complete and file a successful effectiveness study," said Dr. Michael Guy, D.V.M., M.S., Ph.D., Jaguar's Vice President of Preclinical and Nonclinical Studies.

Dogs undergoing chemotherapy are an important predictive model for the mechanism of action in humans experiencing diarrhea due to cancer treatment. Many cancer treatment agents provided to dogs are human drugs, or have the same mechanism of action as human cancer drugs, and these agents and mechanisms of action often have meaningful rates of diarrhea in dogs and humans.

A report by the American Veterinary Medical Foundation concluded that there were approximately 90 million dogs in the U.S. in 2024, of which Jaguar estimates more than 11 million suffer from general diarrhea each year. Data from the European Pet Food Industry Federation concluded that there were approximately 104 million dogs in Europe in 2022.

Canalevia is not an antibiotic drug. The overuse and misuse of antibiotics, both in humans and animals, contribute to the development of bacteria that are resistant to antibiotics.

Diarrhea is one of the most common reasons dogs are seen by general practice veterinarians and is the second most common reason for visits to veterinary emergency hospitals, yet there is currently no FDA-approved drug to treat general, non-infectious diarrhea in dogs. Devastating diarrhea-related dehydration can occur rapidly for the animal, and the lack of easy access to outdoor facilities is a significant problem for families living in urban settings with dogs.

About Chemotherapy-induced Diarrhea (CID) in Dogs

According to the American Veterinary Medical Association, approximately 1 in 4 dogs will at some stage in their life develop cancer. Nearly half of dogs over 10 will develop cancer.¹ According to the National Cancer Institute at the National Institutes of Health, roughly 6 million new cancer diagnoses are made in dogs yearly in the US.

Due to the increasing number of chemotherapeutic agents, chemotherapy is fast becoming the most widely used cancer treatment in veterinary medicine. Studies have found the incidence of CID to be one of the three most prevalent side effects in dogs undergoing cancer treatment,² and managing side-effects such as diarrhea can be important to maintain successful cancer treatment. More than half of the US veterinarians who responded to a Jaguar-sponsored survey reported that CID interferes with their canine patients' chemotherapy treatment plans, indicating an unmet need for an effective product for the treatment of CID.

Important Safety Information About Canalevia^®-CA1

For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 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.

About the Jaguar Health Family of Companies

Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. 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 www.napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Magdalena Biosciences, visit magdalenabiosciences.com
Canalevia-CA1, visit canalevia.com

Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements." 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.

¹ "Cancer in Pets." American Veterinary Medical Association, 2021, https://www.avma.org/resources/pet-owners/petcare/cancer-pets

² Mason SL, Grant IA, Elliott J, Cripps P, Blackwood L. Gastrointestinal toxicity after vincristine or cyclophosphamide administered with or without maropitant in dogs: a prospective randomised controlled study. J Small Anim Pract. 2014;55:391-398

Contact:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

FAQ

What did Jaguar Health (JAGX) announce about FDA funding on January 1, 2026?

Jaguar received a $240,000 grant from FDA CVM to support the Canalevia-CA1 CID effectiveness study.

What is the regulatory status of Canalevia-CA1 for chemotherapy-induced diarrhea in dogs (JAGX)?

Canalevia-CA1 holds a conditional approval renewed for a fifth and final year through December 21, 2026.

What must Jaguar Health (JAGX) do to obtain full FDA veterinary approval for Canalevia-CA1?

Jaguar must complete and file a successful effectiveness study demonstrating benefit for CID in dogs.

How does the FDA grant affect Jaguar Health's (JAGX) Canalevia-CA1 program timeline?

The $240,000 grant supports the ongoing effectiveness study required before the Dec 21, 2026 conditional approval expiry.

Is Canalevia an antibiotic and does it target infectious diarrhea in dogs (JAGX)?

Canalevia is not an antibiotic and is directed at non-infectious chemotherapy-induced diarrhea in dogs.

Does an FDA-approved drug currently exist for general non-infectious diarrhea in dogs?

According to the announcement, there is currently no FDA-approved drug to treat general, non-infectious diarrhea in dogs.