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Jaguar Health Reports Approval of All Proposals at December 2025 Special Meeting of Stockholders

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Jaguar Health (NASDAQ:JAGX) reported that stockholders approved all three proposals at the Special Meeting held on December 8, 2025. The company highlighted early clinical and regulatory developments for crofelemer in microvillus inclusion disease (MVID): an investigator-initiated proof-of-concept trial showed crofelemer may extend infant lives and reduce total parenteral support (PS) volumes by up to 37%, though the report notes associated toxicity. Jaguar completed a meeting with the FDA on October 2, 2025 to seek advice on advancing its placebo-controlled crofelemer trial toward a possible expedited approval pathway. CEO Lisa Conte will present updates on December 10, 2025, 3:25–3:35 PM ET at the Emerging Growth Conference.

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Positive

  • Stockholders approved all three proposals at Dec 8, 2025 meeting
  • Investigator trial reported PS reduction of up to 37%
  • Company held FDA meeting on Oct 2, 2025 about expedited pathway

Negative

  • Initial trial results include associated toxicity in infants
  • Clinical data described as initial and from an investigator-initiated study

News Market Reaction – JAGX

+1.85%
9 alerts
+1.85% News Effect
+19.4% Peak in 27 hr 41 min
+$83K Valuation Impact
$5M Market Cap
0.7x Rel. Volume

On the day this news was published, JAGX gained 1.85%, reflecting a mild positive market reaction. Argus tracked a peak move of +19.4% during that session. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $83K to the company's valuation, bringing the market cap to $5M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

PS reduction in MVID: up to 37% Conference presentation time: 3:25pm–3:35pm Eastern FDA meeting date: October 2, 2025 +1 more
4 metrics
PS reduction in MVID up to 37% Investigator-initiated proof-of-concept trial for crofelemer in infants with MVID
Conference presentation time 3:25pm–3:35pm Eastern CEO presentation at Emerging Growth Conference on December 10
FDA meeting date October 2, 2025 Meeting for advice on advancing placebo-controlled crofelemer MVID trial
Current share price $1.09 Price before publication; near 52-week low of $1.00

Market Reality Check

Price: $0.6090 Vol: Volume 126,402 is below t...
low vol
$0.6090 Last Close
Volume Volume 126,402 is below the 20-day average of 259,681 (relative volume 0.49). low
Technical Shares trade below the 200-day moving average of $4.40, reflecting a longer-term downtrend.

Peers on Argus

Among close biotech peers, moves were mixed: QNRX down 8.41%, ONCO down 13.59%, ...
1 Down

Among close biotech peers, moves were mixed: QNRX down 8.41%, ONCO down 13.59%, GRI up 1.48%. With only one peer in the momentum scanner and no clear shared direction, action in JAGX appears more stock-specific than broad sector-driven.

Historical Context

5 past events · Latest: Dec 02 (Positive)
Pattern 5 events
Date Event Sentiment Move Catalyst
Dec 02 EU regulatory update Positive -1.3% EMA advice request on Canalevia EU approval pathway for canine diarrhea.
Nov 24 Patent and data Positive +5.0% New Australian patent plus early crofelemer PS‑reduction data in SBS and MVID.
Nov 20 Clinical trial protocol Positive -8.2% Amended FDA trial protocol backing possible expedited approval for MVID.
Nov 17 Earnings and update Negative +1.4% Q3 2025 revenue growth but sizable net loss and negative EBITDA reported.
Nov 14 Earnings webcast notice Neutral +4.7% Announcement of timing and access details for Q3 2025 webcast.
Pattern Detected

Recent news has often produced modest and sometimes contrary price reactions, with more divergence than alignment to headline tone.

Recent Company History

Over the last month, Jaguar issued multiple updates spanning regulatory, clinical, and financing themes. On Nov 14 and Nov 17, it highlighted Q3 2025 financials and an investor webcast, alongside ongoing losses. Subsequent releases on Nov 20 and Nov 24 detailed crofelemer clinical progress, IP expansion, and investigator-initiated data. On Dec 2, Jaguar outlined its EU pathway for Canalevia in dogs. Today’s approval of all Special Meeting proposals ties directly back to the financing-related proxy items described in these recent filings.

Regulatory & Risk Context

Active S-3 Shelf
Shelf Active
Active S-3 Shelf Registration 2025-10-03

An effective S-3 shelf registration filed on 2025-10-03 allows Jaguar to flexibly issue registered securities as described in the filing. The shelf has been used at least once, as indicated by a related 424B3 prospectus on 2025-11-25, which registered existing investors’ shares for resale.

Market Pulse Summary

This announcement confirms that all proposals at the December 8, 2025 Special Meeting were approved,...
Analysis

This announcement confirms that all proposals at the December 8, 2025 Special Meeting were approved, advancing previously disclosed financing and capital-structure plans tied to Series N preferred stock and PIPE securities. It also reiterates clinical momentum for crofelemer in MVID and recent FDA interactions. Investors may monitor how these approvals influence future issuances under the effective S-3, progress in the placebo-controlled MVID trial, and the company’s ability to address its noted going-concern and liability profile.

Key Terms

proof-of-concept trial, parenteral support, microvillus inclusion disease, placebo-controlled trial, +2 more
6 terms
proof-of-concept trial medical
"Initial results of ongoing investigator-initiated proof-of-concept trial demonstrate crofelemer..."
A proof-of-concept trial is an early clinical study that tests whether a new drug or medical treatment produces the intended effect in people; think of it as a prototype demo that checks if the idea actually works in real patients. For investors it matters because positive results lower scientific and commercial risk, increase the likelihood of further development and regulatory approval, and often trigger share-price moves or new financing, while negative results can sharply reduce a project’s value.
parenteral support medical
"...reducing the volume of the total parenteral support (PS) necessary for them to survive..."
Parenteral support is medical care that delivers nutrition, fluids or medications directly into a patient’s bloodstream or body tissues, bypassing the digestive system—think of it as feeding or hydrating someone through an IV rather than by mouth. Investors care because this service involves specialized products, durable revenue from long-term patient use, strict safety and reimbursement rules, and potential regulatory or supply risks that affect company earnings and growth.
microvillus inclusion disease medical
"...infants born with intestinal failure due to microvillus inclusion disease (MVID)..."
A rare, inherited condition in which the tiny, brush-like hairs on the inner lining of the small intestine are absent or abnormal, causing severe, lifelong diarrhea and inability to absorb nutrients. Think of the intestine’s surface as a shaggy carpet that helps soak up food; when those fibers are missing or disorganized, patients often need long-term intravenous feeding and specialized care. For investors, the disease matters because it creates clear demand for diagnostics, nutritional support, transplant solutions, and targeted therapies in the orphan-disease market.
placebo-controlled trial medical
"...advice on advancing its ongoing placebo-controlled trial of crofelemer in support of possible..."
A clinical study in which one group receives the experimental medicine and another gets an inactive look‑alike (placebo), with participants—and often researchers—kept unaware of who got which, like a blind taste test. Investors care because this clean comparison helps show whether benefits are real or just expectation, and strong placebo‑controlled results are a key signal for regulators, market acceptance, and commercial prospects.
expedited approval pathway regulatory
"...trial of crofelemer in support of possible expedited approval pathway for crofelemer for treatment..."
An expedited approval pathway is a regulatory process that lets a drug, medical device or treatment reach the market faster than the standard route when it addresses a serious condition or unmet medical need. For investors, it matters because faster reviews can shorten time to sales and reduce development costs—like a fast lane at an airport—while still carrying regulatory and clinical risks if safety or effectiveness questions remain.
Special Meeting of Stockholders regulatory
"...voting results of the Company's Special Meeting of Stockholders held on December 8, 2025..."
A special meeting of stockholders is an unscheduled gathering called to let shareholders vote on specific, often urgent company decisions—like mergers, major asset sales, changes to the board, or amendments to governing rules. Think of it as an emergency town hall where owners cast ballots in person or by mail/online; outcomes can materially change a company’s strategy, control or value, so investors pay close attention and may need to vote or adjust holdings accordingly.

AI-generated analysis. Not financial advice.

Jaguar CEO Lisa Conte presenting December 10 from 3:25pm - 3:35pm Eastern at the Emerging Growth Conference to provide updates on near-term catalysts; Click here to register

Initial results of ongoing investigator-initiated proof-of-concept trial demonstrate crofelemer can potentially extend the lives of infants born with intestinal failure due to microvillus inclusion disease (MVID), reducing the volume of the total parenteral support (PS) necessary for them to survive, though with associated toxicity; Groundbreaking PS reduction of up to 37%; No approved treatments exist for MVID

Company completed meeting with FDA October 2, 2025 for advice on advancing its ongoing placebo-controlled trial of crofelemer in support of possible expedited approval pathway for crofelemer for treatment of MVID

SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / December 8, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today announced the voting results of the Company's Special Meeting of Stockholders held on December 8, 2025 (the "Special Meeting").

Three proposals were submitted to and approved by the stockholders of the Company at the Special Meeting. The proposals are described in detail in the Company's definitive proxy statement on Schedule 14A relating to the Special Meeting filed with the Securities and Exchange Commission on November 10, 2025. Stockholders may obtain a free copy of the proxy statement and other documents filed by Jaguar with the SEC at http://www.sec.gov. The proxy statement is also available on the Company's corporate website.

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. Napo's crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. 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

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Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that Jaguar management will present at the December 2025 Emerging Growth Conference, Jaguar's expectation that crofelemer can potentially extend the lives of infants born with intestinal failure due to MVID, reducing the volume of PS necessary for them to survive, and Jaguar's expectation that an expedited approval pathway may be possible for crofelemer for treatment of MVID. 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 several 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.

Source: Jaguar Health, Inc.

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 on December 8, 2025?

Stockholders approved all three proposals at the Special Meeting held on December 8, 2025.

What were the initial crofelemer trial results reported by Jaguar Health for MVID?

An investigator-initiated proof-of-concept trial showed potential life extension and a up to 37% reduction in total parenteral support volumes, with associated toxicity.

When did Jaguar meet the FDA about crofelemer and what was discussed?

Jaguar completed a meeting with the FDA on October 2, 2025 to seek advice on advancing its placebo-controlled crofelemer trial toward a possible expedited approval pathway.

How does the reported 37% PS reduction affect MVID treatment prospects for JAGX?

The up to 37% PS reduction is an early clinical signal that could support further development, but it was accompanied by reported toxicity and is not definitive evidence of efficacy.

When and where will Jaguar CEO Lisa Conte present updates about near-term catalysts?

CEO Lisa Conte will present on December 10, 2025, 3:25–3:35 PM ET at the Emerging Growth Conference.
Jaguar Health Inc

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Biotechnology
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