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Jaguar Health (JAGX) starts strategic review tied to rare disease NDA

Filing Impact
(Very High)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Jaguar Health, Inc. has started a formal process to explore a range of strategic alternatives aimed at maximizing shareholder value. The Board’s decision follows an evaluation of current market conditions.

The company expects the timing of this review to align with completion of clinical work supporting a planned New Drug Application for its crofelemer prescription drug candidate targeting rare intestinal failure diseases. Jaguar emphasizes that these plans are forward-looking and subject to significant risks and uncertainties described in its prior SEC reports.

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Insights

Jaguar is launching a strategic review tied to its rare-disease drug program.

Jaguar Health is initiating a process to evaluate “strategic alternatives,” a broad term that can include partnerships, licensing deals, financings, or potential business combinations. The review is explicitly framed around maximizing shareholder value, suggesting a focus on unlocking perceived value in its pipeline.

The company expects this process to track the completion of clinical work needed for a New Drug Application for crofelemer in rare intestinal failure diseases. Regulatory milestones often influence strategic options, since potential partners or acquirers weigh late-stage assets differently from earlier programs.

The outcome, scope, and timing of any specific transaction are not described and remain uncertain. Investors will likely look to future SEC filings or press releases around the NDA-related clinical work and any resulting strategic actions to gauge how this review ultimately affects Jaguar’s development program and capitalization.

Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
strategic alternatives financial
"its Board of Directors has decided to initiate a process to explore and review a range of strategic alternatives"
Strategic alternatives are different options a company considers to improve its value or achieve its goals, such as selling the business, merging with another company, or restructuring operations. For investors, understanding these options is important because they can significantly impact the company's future direction and its stock value, often signaling potential changes or opportunities.
New Drug Application regulatory
"support of the filing of a New Drug Application by the Company for its crofelemer prescription drug candidate"
A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.
forward-looking statements regulatory
"contains “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
intestinal failure diseases medical
"crofelemer prescription drug candidate for rare intestinal failure diseases"
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FAQ

What strategic alternatives is Jaguar Health (JAGX) considering?

Jaguar Health is beginning a process to explore and review a range of strategic alternatives focused on maximizing shareholder value. These alternatives are not specified, but typically can include partnerships, licensing, financings, or broader corporate transactions, depending on market conditions and pipeline progress.

Why is Jaguar Health (JAGX) launching a strategic review now?

Jaguar Health’s Board initiated the strategic review after evaluating current market conditions. The company expects the process to align with completion of clinical work that will support filing a New Drug Application for its crofelemer prescription drug candidate for rare intestinal failure diseases.

How does Jaguar Health’s crofelemer program relate to this 8-K filing?

The 8-K notes Jaguar Health expects its strategic exploration to align with clinical work supporting a planned New Drug Application for crofelemer in rare intestinal failure diseases. The company believes identifying a suitable alternative could help maximize the value of this intestinal failure development program.

Are Jaguar Health’s (JAGX) strategic plans in this filing guaranteed to happen?

No. Jaguar Health describes its strategic review and New Drug Application timing as forward-looking statements subject to risks and uncertainties. The company cautions that actual results, performance, or achievements could differ materially from these expectations, and it assumes no obligation to update such statements.

Does Jaguar Health (JAGX) give financial results in this 8-K?

No financial results are discussed. The 8-K focuses on Jaguar Health’s decision to explore strategic alternatives and the expected alignment with clinical work for a future New Drug Application related to its crofelemer prescription drug candidate for rare intestinal failure diseases.

What document is attached to Jaguar Health’s 8-K about strategic alternatives?

The 8-K includes Exhibit 99.1, a press release dated June 22, 2026, describing Jaguar Health’s plan to explore strategic alternatives. The company states this exhibit is furnished, not filed, under the Exchange Act and is not automatically incorporated into other SEC filings.
NASDAQ false 0001585608 0001585608 2026-06-22 2026-06-22
 
 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 22, 2026

 

 

JAGUAR HEALTH, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36714   46-2956775

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

200 Pine Street, Suite 400  
San Francisco, California   94104
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (415) 371-8300

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading
Symbol(s)

 

Name of each exchange
on which registered

Common Stock, Par Value $0.0001 Per Share   JAGX   The Nasdaq Capital Market

 

 
 


Item 7.01

Regulation FD Disclosure.

On June 22, 2026, Jaguar Health, Inc. (the “Company”) issued a press release announcing that, following an evaluation of current market conditions, its Board of Directors has decided to initiate a process to explore and review a range of strategic alternatives focused on maximizing shareholder value. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information under Item 7.01 and in Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liabilities thereof, nor shall it be deemed to be incorporated by reference in any filing under the Exchange Act or under the Securities Act of 1933, except to the extent specifically provided in any such filing.

This Current Report on Form 8-K contains “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the Company’s plan to explore potential strategic alternatives, the Company’s expectation that the timing of this strategic exploration process will align with the anticipated completion of clinical work in support of the filing of a New Drug Application by the Company for its crofelemer prescription drug candidate for rare intestinal failure diseases, and the Company’s expectation that the process of identifying a suitable strategic alternative will support its goal of maximizing the value of its intestinal failure development program and benefit all stakeholders. The words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. While the Company believes its plans, intentions and expectations reflected in those forward-looking statements are reasonable, these plans, intentions or expectations may not be achieved. The Company’s actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements. For information about the factors that could cause such differences, please refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, including the information discussed under the captions “Item 1 Business,” “Item 1A. Risk Factors” and “Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as well as the Company’s various other filings with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The Company assumes no obligation to update any forward-looking statement.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit
No.

  

Description

99.1    Press Release, dated June 22, 2026
104    Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

- 2 -


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

JAGUAR HEALTH, INC.
By:  

/s/ Lisa A. Conte

Name:   Lisa A. Conte
Title:   President and Chief Executive Officer

Date: June 22, 2026

 

- 3 -

Exhibit 99.1

 

LOGO

Jaguar Health Announces Plan to Explore Strategic Alternatives to Align with Targeted NDA for Rare Disease Intestinal Failure

Reminder: Lisa Conte, Jaguar’s founder & CEO, to present on June 24, 2026 at the Life Sciences Virtual Investor Forum to provide updates on company’s crofelemer development program for rare intestinal failure diseases; click here to register

San Francisco, CA (June 22, 2026): Jaguar Health, Inc. (NASDAQ: JAGX) (“Jaguar” or the “Company”) today announced that its Board of Directors has initiated a process to explore and review a range of strategic alternatives focused on maximizing stockholder value and aligned with our anticipated completion of the clinical work supporting our filing of a New Drug Application (NDA) by the Company for our crofelemer-based prescription drug candidate for rare intestinal failure diseases. Strategic alternatives under consideration may include, but are not limited to mergers, reverse mergers, acquisitions, partnerships, joint ventures, licensing arrangements or other strategic transactions, and may involve biotech or non-biotech companies.

“We remain sharply focused on and committed to our development program for crofelemer for treatment of rare intestinal failure diseases,” said Lisa Conte, Jaguar’s founder, president, and CEO, “and we believe the process of identifying a suitable strategic alternative for the Company will support our goal of maximizing the value of the opportunity we feel our intestinal failure development program represents – for all stakeholders, including patients, the healthcare community, and Jaguar shareholders.”

Patients with intestinal failure (IF) cannot absorb enough nutrients or fluids and therefore require lifelong nutritional support delivered intravenously, often up to seven days per week and 20 or more hours per day. While lifesaving, nutritional support is associated with serious complications. A third-party market research report estimates that the global value of the nutritional support market for microvillus inclusion disease (MVID), an ultrarare congenital disorder with a lethal natural history and no approved therapies, is approximately $1.1 billion in 2026, rising to approximately $1.5 billion in 2033.1

In an ongoing investigator-initiated proof-of-concept trial in pediatric patients with intestinal failure due to MVID and short bowel syndrome (SBS-IF), crofelemer demonstrated a reduction of parenteral support (nutritional support combined with supplemental intravenous fluids) of up to 37%. A late-breaking abstract providing updates about this trial will be presented at the European Society for Pediatric Gastroenterology, Hepatology & Nutrition (ESPGHAN) Annual Meeting in June 2026.

There can be no assurance that exploration of strategic alternatives by Jaguar will result in the Company entering or completing any transaction. Jaguar does not intend to make any further disclosures regarding the strategic review process unless and until a specific course of action is approved.

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


LOGO

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

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements.” These include statements regarding Jaguar’s plan to explore potential strategic alternatives, Jaguar’s expectation that the timing of this strategic exploration process will align with the anticipated completion of clinical work in support of the filing of a NDA by the Company for its crofelemer prescription drug candidate for rare intestinal failure diseases, Jaguar’s expectation that the process of identifying a suitable strategic alternative for the Company will support Jaguar’s goal of maximizing the value of its intestinal failure development program and benefit all stakeholders, including patients, the healthcare community, and Jaguar shareholders, and Jaguar’s expectation that Jaguar management will present on June 24, 2026 at the Life Sciences Virtual Investor Forum. 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.

 

1 

Global Microvillus Inclusion Disease Market—Industry Trends and Forecast to 2033, Data Bridge Market Research, May 2026

Contact:

hello@jaguar.health

Jaguar-JAGX

Filing Exhibits & Attachments

4 documents