Tilray Accelerates U.S. Medical Cannabis Expansion After Landmark Federal Rescheduling: Launches Tilray Medical USA to Lead Nationwide Medical Cannabis Innovation and Growth

Rhea-AI Summary

Tilray (Nasdaq: TLRY) announced formation of Tilray Medical USA on Dec 18, 2025 to accelerate its planned U.S. medical cannabis expansion after federal cannabis rescheduling. The company highlighted its global medical footprint: 200+ registered medical cannabis products, > 500,000 registered patients served, and participation in > 15 clinical studies. Tilray said it will leverage compliance systems, scientific expertise, and physician partnerships to introduce medical-grade products and support research and clinical trials under evolving U.S. regulation.

Positive

• Tilray Medical USA launched to lead U.S. medical expansion
• 200+ registered medical cannabis products internationally
• Served > 500,000 registered patients globally
• Participated in > 15 medical studies and clinical trials

Negative

• None.

Key Figures

Registered products more than 200 products Global medical cannabis portfolio for therapeutic use

Registered patients over 500,000 patients Patients served globally with medical cannabis products

Studies and trials more than 15 studies and clinical trials Medical cannabis research with hospitals and physicians

International markets over 20 markets Federally regulated international medical cannabis markets operated by Tilray

Market Reality Check

$11.16 Last Close

Volume Price at $12.88 is down 7.6% on volume of 29,628,576 shares, about 1.97x the 20-day average of 15,049,921. high

Technical Shares trade above the 200-day moving average of $8.54, despite the current pullback.

Peers on Argus

TLRY is down 7.6% while key peers show mixed, mostly modest moves: AMPH up 1.84%, PCRX up 1.41%, EVO down 2%, HROW down 1.73%, DVAX flat. This points to a stock-specific reaction rather than a broad sector move.

Common Catalyst Only one peer, PCRX, has same-day news tied to osteoarthritis research, suggesting no shared regulatory or policy theme driving the group.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 11	Product launch	Positive	+2.1%	Launch of Redecan Amped Live Resin Liquid Diamond vape cartridges in Canada.
Dec 04	Marketing campaign	Positive	+2.6%	Holiday drink gift guide highlighting Tilray’s beverage and THC portfolio.
Dec 04	Marketing campaign	Positive	+2.6%	Cannabis holiday gift guide spotlighting leading Canadian products and SKUs.
Nov 26	Reverse stock split	Neutral	+4.8%	Implementation details of 1-for-10 reverse split and new CUSIP 88688T209.
Nov 24	Geographic expansion	Positive	+6.5%	Launch of Good Supply vape cartridges in Québec’s newly opened vape market.

Pattern Detected

Recent TLRY headlines around product launches, consumer campaigns, and the reverse split have generally coincided with positive next-day price reactions.

Recent Company History

Over the past month, Tilray has focused on brand and capital-structure moves. On Nov 24, it expanded Good Supply vapes into Québec’s new legal vape market, followed by holiday cannabis and beverage gift guides on Dec 4, all seeing modestly positive reactions. The 1-for-10 reverse stock split, effective Dec 1, also preceded a gain. Against this backdrop, today’s U.S. medical cannabis expansion and rescheduling commentary contrasts with the current share price decline, despite fitting a longer-term strategic growth narrative.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-10-09

$51,597,980 registered capacity

An effective S-3ASR shelf allows Tilray to sell securities, including up to $51,597,980 of common stock via a forward ATM program and other registered securities, providing capital-raising flexibility along with potential dilution if fully utilized.

Market Pulse Summary

This announcement details Tilray’s response to U.S. federal cannabis rescheduling, including the launch of Tilray Medical USA and plans to leverage experience in over 20 international medical markets. The company cites a portfolio of more than 200 registered products, service to over 500,000 patients, and participation in more than 15 studies and clinical trials. Investors may monitor how U.S. regulatory frameworks evolve, the pace of medical product rollouts, and the capital-raising activity under the company’s existing shelf registration.

Key Terms

clinical trials medical

"expand access to medical research and clinical trials, improve standardization"

Clinical trials are carefully controlled studies that test whether a new drug, device or treatment is safe and effective in people, moving through successive stages that increase the number of participants and the rigor of testing. Investors care because trial outcomes determine whether a product can be approved and sold, shaping a company’s future revenue, valuation and risk profile—think of it as proof-of-concept testing that decides if a prototype becomes a market-ready product.

pediatric epilepsy medical

"studying cannabis for various conditions including pediatric epilepsy, cancer-induced"

A chronic neurological condition in children marked by repeated, unprovoked seizures — bursts of abnormal brain activity that can affect movement, awareness or behavior. Think of it like a recurring electrical short in the brain that requires ongoing management with medicines, devices or surgery. Investors care because pediatric epilepsy shapes demand for drugs, medical devices and long-term care, and regulatory approvals, clinical trial results and reimbursement decisions can materially affect company revenues and valuations.

ptsd medical

"cancer-induced nausea, PTSD, pain, anxiety, essential tremors, alcohol use disorder"

PTSD, or post-traumatic stress disorder, is a mental health condition that can develop after experiencing or witnessing a traumatic event, leading to ongoing feelings of fear, anxiety, or distress. For investors, understanding PTSD is important because widespread psychological impacts can influence market behavior, cause sudden shifts in confidence, or affect economic stability during times of collective trauma or crisis.

fibromyalgia medical

"alcohol use disorder, fibromyalgia, glioblastoma, and cannabinoids and driving"

Fibromyalgia is a long-term condition that causes widespread body pain, extreme tiredness, and problems with sleep, memory and mood; people often feel unusually sensitive to normal touch or pressure, and symptoms can fluctuate from day to day. It matters to investors because it affects workforce productivity, healthcare spending, and demand for treatments—so advances in diagnostics, drugs, or care delivery can change market size and company prospects, much like a fuel problem that reduces a car’s performance and reliability.

glioblastoma medical

"alcohol use disorder, fibromyalgia, glioblastoma, and cannabinoids and driving"

Glioblastoma is a fast-growing and aggressive type of brain tumor that can affect a person's thinking, movement, or senses. Its seriousness and difficulty to treat can lead to significant health impacts, making it a concern for medical research and drug development. For investors, advances or setbacks in glioblastoma treatments can influence biotech companies and healthcare markets focused on cancer therapies.

cannabinoids medical

"fibromyalgia, glioblastoma, and cannabinoids and driving performance."

Compounds that interact with specific receptors in the human body and brain, including those naturally produced by the body, those found in cannabis plants, and lab-made versions. Think of them as keys that can unlock or change biological processes like pain, appetite or mood. Investors track cannabinoids because their health effects, legal status, and product demand drive market opportunities, regulatory risk, and the value of companies developing therapies, consumer products, or supply chains.

cannabis rescheduling regulatory

"following federal cannabis rescheduling and related regulatory developments."

Cannabis rescheduling is the official change in how a government classifies cannabis under its drug control system, which alters legal restrictions on possession, sale, research and medical use. For investors, rescheduling can be like moving an item from a 'restricted' shelf to a more accessible one: it can lower regulatory hurdles, boost access to banks and investors, expand markets and research, and therefore materially affect company revenues, costs and risk profiles.

medical-grade cannabis medical

"aims to introduce medical-grade cannabis products in targeted therapeutic formats"

Medical-grade cannabis is dried plant material, oils or extracts produced to meet quality, potency and safety standards for use as a medical treatment, typically tested for active ingredients and contaminants much like prescription drugs. For investors it matters because products that meet these standards can access regulated healthcare markets, command higher prices and face different legal, supply-chain and reimbursement rules than recreational cannabis—think of it as the prescription version versus the over-the-counter option.

AI-generated analysis. Not financial advice.

Global Cannabis Leader Poised for Major U.S. Market Entry, Signaling New Era for Healthcare

NEW YORK, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Tilray Medical, a division of Tilray Brands, Inc. (“Tilray” or the “Company”) (Nasdaq: TLRY; TSX: TLRY) and a global leader in medical cannabis healthcare, today confirmed its planned strategic framework to advance its U.S. medical cannabis operations following federal cannabis rescheduling and related regulatory developments. In conjunction with these regulatory changes, Tilray announced the formation of Tilray Medical USA, Inc., further strengthening its commitment to leading medical cannabis innovation and growth. The Company’s approach is grounded in its proven track record operating at scale in regulated medical cannabis markets globally, supported by established compliance systems, scientific expertise, and disciplined governance. Tilray also issued the following statement in response to President Trump’s decision to reschedule cannabis.

Irwin D. Simon, Chairman and Chief Executive Officer of Tilray Brands, stated, “We support President Trump’s decision to reschedule cannabis as a constructive and necessary evolution of U.S. federal policy. This action aligns regulation with a vast body of scientific and medical data supporting cannabis medical use and safety, economic progress, and a healthcare-focused framework, while creating a more credible foundation for medical cannabis research, clinical development, and regulatory clarity. It also signals a future shaped by innovation, responsible oversight, and evidence-based policy. We believe this landmark decision is a significant catalyst for positive change within the health, wellness, and business communities across the U.S. and a critical, incremental step toward descheduling and comprehensive regulation.”

Mr. Simon continued, “Tilray has dedicated years to developing the necessary infrastructure, scientific knowledge, and regulatory skills to operate responsibly in federally legal medical cannabis markets. As U.S. policies evolve, we’re prepared to engage thoughtfully and in full compliance - just as we have led in over 20 international medical cannabis markets. We believe we are well-positioned to take the lead as we have the experienced team in place and remain committed to supporting the development and growth of a research-focused federal medical cannabis industry in the U.S.”

The direct and indirect impacts of federal cannabis rescheduling have the potential to expand access to medical research and clinical trials, improve standardization, and support the development of evidence-based cannabis therapies - key prerequisites for an integrated state-federal medical cannabis framework within the U.S. healthcare system.

Tilray Medical has built its leadership in federally regulated medical cannabis markets globally by working closely with regulators, physicians, hospitals, and research institutions to uphold the highest standards of quality, compliance, and patient safety. Tilray currently offers more than 200 registered medical cannabis products across international markets for therapeutic use, has served over 500,000 registered patients globally, and has participated in more than 15 medical cannabis studies and clinical trials in partnership with leading hospitals and physicians studying cannabis for various conditions including pediatric epilepsy, cancer-induced nausea, PTSD, pain, anxiety, essential tremors, alcohol use disorder, fibromyalgia, glioblastoma, and cannabinoids and driving performance.

With an established global footprint, mature compliance infrastructure, and deep scientific and regulatory expertise, Tilray Medical plans to adapt swiftly to regulatory developments while maintaining the highest standards of governance, patient safety, and operational integrity. The Company intends to strategically expand collaborations with healthcare operators and medical professionals, ensuring all partnerships are aligned with emerging regulatory medical guidelines. As part of its forward-looking plan, Tilray Medical USA aims to introduce medical-grade cannabis products in targeted therapeutic formats, drawing on real-world data and physician-driven insights accumulated from its international operations.

About Tilray Brands
Tilray Brands, Inc. (“Tilray”) (Nasdaq: TLRY; TSX: TLRY), is a leading global lifestyle and consumer packaged goods company with operations in Canada, the United States, Europe, Australia, and Latin America that is leading as a transformative force at the nexus of cannabis, beverage, wellness, and entertainment, elevating lives through moments of connection. Tilray’s mission is to be a leading premium lifestyle company with a house of brands and innovative products that inspire joy and create memorable experiences. Tilray’s unprecedented platform supports over 40 brands in over 20 countries, including comprehensive cannabis offerings, hemp-based foods, and craft beverages.

For more information on Tilray’s brand portfolio, visit Tilray.com and follow @Tilray on all social platforms.

Forward-Looking Statements
Certain statements in this communication that are not historical facts constitute forward-looking information or forward-looking statements (together, “forward-looking statements”) under Canadian and U.S. securities laws and within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be subject to the “safe harbor” created by those sections and other applicable laws. Forward-looking statements can be identified by words such as “forecast,” “future,” “should,” “could,” “enable,” “potential,” “contemplate,” “believe,” “anticipate,” “estimate,” “plan,” “expect,” “intend,” “may,” “project,” “will,” “would” and the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Certain material factors, estimates, goals, projections, or assumptions were used in drawing the conclusions contained in the forward-looking statements throughout this communication. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses, or current expectations. Many factors could cause actual results, performance, or achievement to be materially different from any forward-looking statements, and other risks and uncertainties not presently known to the Company or that the Company deems immaterial could also cause actual results or events to differ materially from those expressed in the forward-looking statements contained herein. For a more detailed discussion of these risks and other factors, see the most recently filed annual information form of Tilray and the Annual Report on Form 10-K (and other periodic reports filed with the SEC) of Tilray made with the SEC and available on EDGAR. The forward-looking statements included in this communication are made as of the date of this communication and the Company does not undertake any obligation to publicly update such forward-looking statements to reflect new information, subsequent events, or otherwise unless required by applicable securities laws.

For further information, please contact

Media: news@tilray.com
Investors: investors@tilray.com

FAQ

What did Tilray announce on December 18, 2025 about U.S. operations (TLRY)?

Tilray announced the formation of Tilray Medical USA to expand U.S. medical cannabis activities following federal rescheduling.

How many medical cannabis products does Tilray have that support its U.S. roll‑out (TLRY)?

Tilray currently offers more than 200 registered medical cannabis products across international markets.

What clinical and research experience did Tilray cite to support its U.S. expansion (TLRY)?

Tilray said it has participated in over 15 clinical studies and worked with hospitals and physicians on multiple therapeutic areas.

How many patients has Tilray served that management referenced in the announcement (TLRY)?

Management referenced serving over 500,000 registered patients globally.

What strategic capabilities did Tilray highlight for its U.S. medical plans (TLRY)?

The company cited its compliance systems, scientific expertise, and established regulatory governance as core capabilities.