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[6-K] Curaleaf Holdings, Inc. Current Report (Foreign Issuer)

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(Neutral)
Filing Sentiment
(Neutral)
Form Type
6-K

Rhea-AI Filing Summary

Curaleaf Holdings, Inc. reports that Spain’s medicines regulator, AEMPS, has formally approved the registration of two standardized cannabis preparations, one THC‑dominant and one CBD‑dominant, developed by its Spanish manufacturing subsidiary. These registrations, listed as CAN‑1 and CAN‑2, are the first under Spain’s new medicinal cannabis framework, Royal Decree 903/2025, and clear the path for supply to hospital pharmacies for use in magistral formulas pursuant to medical prescription.

The milestone builds on Curaleaf’s EU‑GMP certified manufacturing facility and R&D laboratory in Alicante and on Medalchemy SL’s 2020 AEMPS license to process medicinal cannabis derivatives. Spain, a country of nearly 50 million people, is described as central to Curaleaf’s vision for Europe. The preparations are expected to become available to patients through hospital pharmacies in due course, in line with the new framework and subject to actions by Spanish health authorities.

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Standardized preparations registered 2 preparations THC-dominant and CBD-dominant cannabis preparations approved by AEMPS
Royal Decree 903/2025 Spanish framework for medicinal use of standardized cannabis preparations
Registry numbers CAN-1 and CAN-2 Official AEMPS registry numbers for Curaleaf’s standardized preparations
Spain population nearly 50 million people Described as central market for Curaleaf’s European vision
First AEMPS processing license date May 2020 Medalchemy SL secured first license to process medicinal cannabis derivatives
Royal Decree approval date October 7, 2025 Date Spain’s Council of Ministers approved Royal Decree 903/2025
standardized cannabis preparations medical
"formally approved the registration of two standardized cannabis preparations"
magistral formulas medical
"used in the production of magistral formulas pursuant to medical prescription"
Royal Decree 903/2025 regulatory
"Spain's regulatory framework for the medicinal use under Royal Decree 903/2025"
EU-GMP certified regulatory
"operates an EU-GMP certified manufacturing facility and R&D laboratory in Alicante"
A EU-GMP certified facility has been inspected and approved under the European Union’s Good Manufacturing Practice rules, which ensure medicines and related products are made consistently to required quality and safety standards. Think of it like a restaurant passing a strict health inspection for every dish. For investors, the certification lowers regulatory and product-risk, helps secure access to EU markets, and signals reliable production and supply chains.
medicinal cannabis derivatives medical
"license granted by AEMPS to process medicinal cannabis derivatives for commercial distribution"
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the month of July, 2026
Commission File Number: 333-249081
Curaleaf Holdings, Inc.
(Name of Registrant)
666 Burrard Street, Suite 1700,
Vancouver, British Columbia V6C 2X8, Canada
(Address of Principal Executive Office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☐    Form 40-F ☒


SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
CURALEAF HOLDINGS, INC.
(Registrant)
Date:
July 13, 2026
By:
/s/ Peter Clateman
Name:
Peter Clateman
Title:
Chief Legal Officer


EXHIBIT INDEX

Exhibit Number
Description
99.1
Press Release

Curaleaf Holdings, Inc. Investor Relations Curaleaf First to Secure Registration for Standardized Cannabis Preparations in Spain Milestone reinforces Curaleaf's leadership in bringing pharmaceutical-grade cannabis products to emerging international markets STAMFORD, Conn., July 13, 2026 /PRNewswire/ -- Curaleaf Holdings, Inc. (TSX: CURA) (OTCQX: CURLF) ("Curaleaf" or the "Company"), a leading international provider of consumer cannabis products, today announced that the Spanish Agency of Medicines and Medical Devices ("AEMPS") has formally approved the registration of two standardized cannabis preparations (THC-dominant and CBD-dominant) developed by Curaleaf's Spanish manufacturing subsidiary. These registrations clear the regulatory pathway for the supply of preparations to hospital pharmacies, where they can be used in the production of magistral formulas pursuant to medical prescription. Based on the official registry numbering (CAN-1 and CAN-2), Curaleaf is the first company to register standardized cannabis preparations in Spain under the country's new regulatory framework, Royal Decree 903/2025. Approved by Spain's Council of Ministers on October 7, 2025, Royal Decree 903/2025 establishes Spain's regulatory framework for the medicinal use of standardized cannabis preparations, setting out the requirements for their production, quality standards, and registration with AEMPS. It provides, for the first time, a clear national pathway for patients to access standardized cannabis preparations through the healthcare system. Curaleaf's registrations under this new framework mark one of the first steps in bringing that pathway to life. The registrations build on Curaleaf's long-established presence in Spain, where the Company operates an EU-GMP certified manufacturing facility and R&D laboratory in Alicante. In May 2020, Curaleaf's EU-GMP laboratory, Medalchemy SL, secured the first-ever license granted by AEMPS to process medicinal cannabis derivatives for commercial distribution, an early milestone that laid the foundation for today's achievement. 'Spain, a country of nearly 50 million people, has always been central to Curaleaf's vision for Europe, and this registration is a defining moment for us," said Boris Jordan, CEO and Chairman of Curaleaf. "We were the first company to be licensed here in 2020, and we believe we are the first to register under this new framework today. This achievement reflects the strength of our team, our sustained investment in science, and our conviction that patients deserve access to standardized, high-quality cannabis medicines." The standardized preparations are expected to become available to patients through hospital pharmacies in due course, in line with the requirements of the new framework. Curaleaf will continue to work alongside healthcare professionals and partners to support access as Spain's regulated system takes shape. About Curaleaf Holdings Curaleaf Holdings, Inc. (TSX: CURA) (OTCQX: CURLF) ("Curaleaf") is a leading international provider of consumer products in cannabis with a mission to enhance lives by cultivating, sharing and celebrating the power of the plant. As a high-growth cannabis company known for quality, expertise and reliability, the Company and its brands, including Curaleaf, Select, Grassroots, Find, Dark Heart, and Anthem, provide industry-leading service, product selection and accessibility across the medical and adult use markets. Curaleaf International is powered by a strong presence in all stages of the supply chain. Its unique distribution network throughout Europe, Canada and Australasia brings together pioneering science and research with cutting-edge cultivation, extraction and production. Curaleaf is listed on the Toronto Stock Exchange under the symbol CURA and trades on the OTCQX market under the symbol CURLF. For more information, please visit https://ir.curaleaf.com. Forward Looking Statement This news release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward–looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as "plans", "expects" or "proposed", "is expected", "intends", "anticipates", or "believes", or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. More particularly and without limitation, this news release contains forward-looking statements and information concerning the expected availability of the Company's standardized cannabis preparations to patients through hospital pharmacies in Spain, the timing thereof, the anticipated implementation and rollout of Spain's regulatory framework for the medicinal use of standardized cannabis preparations under Royal Decree 903/2025, and the Company's ability to support patient access as that framework takes shape. The availability of these preparations is subject to the requirements of the new regulatory framework, the discretion of Spanish health authorities, and the pace at which the regulated system is implemented and may be delayed or may not occur as anticipated. There can be no assurance that any of these potential effects will be realized within the expected timeframe or at all, as implementation depends on regulatory action and other factors outside the Company's control. Such forward-looking statements and information reflect management's current beliefs and are based on assumptions made by and information currently available to the Company with respect to the matter described in this news release. Forward-looking statements involve risks and uncertainties, which are based on current expectations as of the date of this release and subject to known and unknown risks

 

and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Additional information about these assumptions and uncertainties is contained under "Risk Factors and Uncertainties" in the Company's latest annual information form filed on February 26, 2026, which is available under the Company's profile on SEDAR+ at www.sedarplus.ca, and in other filings that the Company has made and may make with applicable securities authorities in the future. Forward-looking statements contained herein are made only as to the date of this press release and we undertake no obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. The Toronto Stock Exchange has not reviewed, approved or disapproved the content of this news release. Investor Contact: Curaleaf Holdings, Inc. Camilo Lyon, Chief Investment Officer IR@curaleaf.com Media Contact: MATTIO Communications MattioCuraleaf@Mattio.com SOURCE Curaleaf Holdings, Inc. https://ir.curaleaf.com/2026-07-13-Curaleaf-First-to-Secure-Registration-for-Standardized-Cannabis-Preparations-in-Spain

 

Source: View Original Filing on SEC EDGAR

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