Ensysce Biosciences Receives EU Patent Expanding its First-in-Class ADHD Therapy with Built-In Abuse and Overdose Protection

Rhea-AI Summary

Ensysce Biosciences (NASDAQ:ENSC) received a Notice of Allowance from the European Patent Office for a patent covering PF8026, an immediate-release amphetamine prodrug using the company's TAAP™ and MPAR® technologies for built-in abuse and overdose protection. The allowed claims cover composition of matter and method of use, expanding Ensysce's ADHD portfolio alongside PF8001 validated in clinical studies and cites a 2023 figure of ~3.9 million people aged 12+ who misused prescription stimulants, framing the program as addressing misuse and overdose risk.

Positive

• European Patent Notice of Allowance for PF8026 covering composition and method claims
• PF8026 uses TAAP™ and MPAR® to block common abuse routes and add overdose protection
• MPAR® overdose protection has been validated in clinical studies
• Pipeline now includes both PF8026 PF8001 (extended release)

Negative

• ADHD stimulant misuse remains significant: ~3.9 million people aged 12+ misused prescription stimulants in 2023

News Market Reaction

-0.93%

1 alert

-0.93% News Effect

-3.5% Trough Tracked

-$37K Valuation Impact

$4M Market Cap

0.1x Rel. Volume

On the day this news was published, ENSC declined 0.93%, reflecting a mild negative market reaction. Argus tracked a trough of -3.5% from its starting point during tracking. This price movement removed approximately $37K from the company's valuation, bringing the market cap to $4M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Stimulant misuse: 3.9 million people

1 metrics

Stimulant misuse 3.9 million people Prescription stimulant misuse in 2023 (aged 12 or older)

Market Reality Check

Price: $0.9300 Vol: Volume 102,139 is 0.22x t...

low vol

$0.9300 Last Close

Volume Volume 102,139 is 0.22x the 20-day average of 456,371, suggesting a modest reaction so far. low

Technical Price at $1.07 is trading below the $2.11 200-day MA and remains far under the $9.31 52-week high.

Peers on Argus

ENSC is up 5.94% while close peers show mixed moves (e.g., ARTL up 16.54%, PLRZ ...

1 Up

ENSC is up 5.94% while close peers show mixed moves (e.g., ARTL up 16.54%, PLRZ down 3.55%, TTNP down 3.96%). Momentum scanners only flag one other biotech (PMCB up 7.23%), supporting a stock‑specific move.

Historical Context

5 past events · Latest: Jan 05 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 05	Shareholder update	Positive	+10.6%	Annual letter outlining 2025 clinical, regulatory, IP and financing progress.
Dec 09	Clinical milestone	Positive	-11.3%	First patient enrolled in pivotal Phase 3 PF614 pain trial PF614-301.
Dec 02	IP expansion	Positive	-4.6%	U.S. Notice of Allowance extending MPAR overdose protection patents to 2042.
Nov 20	Regulatory feedback	Positive	-12.0%	FDA agreed with PF614 manufacturing approach, enabling commercial‑scale production.
Nov 17	Financing deal	Positive	-4.8%	$4M convertible preferred financing unlocking up to $20M for PF614 development.

Pattern Detected

Recent history shows multiple positive clinical, IP, and financing updates often met with negative price reactions, with the latest shareholder letter as a notable positive outlier.

Recent Company History

Over the last few months, Ensysce reported several milestones tied to its TAAP and MPAR platforms. In Nov–Dec 2025, it advanced PF614 into a pivotal Phase 3 trial, received positive FDA manufacturing feedback, and broadened MPAR patent protection through 2042. Financing in Nov 2025 provided up to $20M to support these programs. A Jan 05, 2026 shareholder letter highlighted clinical, regulatory, IP, and funding progress. Today’s EU patent allowance for PF8026 adds ADHD‑focused IP on top of this existing pain and overdose‑protection portfolio.

Market Pulse Summary

This announcement expands Ensysce’s intellectual property with a European patent covering PF8026, an...

Analysis

This announcement expands Ensysce’s intellectual property with a European patent covering PF8026, an ADHD prodrug that embeds TAAP™ abuse protection and MPAR® overdose-resistance features. It extends the company’s strategy of pairing efficacy with safety in CNS and pain indications. In light of recent progress on MPAR patents and PF614’s Phase 3 program, investors may focus on how this ADHD asset advances clinically, the scope and duration of patent protection, and future regulatory interactions across regions.

Key Terms

prodrug, notice of allowance, european patent office, composition of matter

4 terms

prodrug medical

"PF8026 is a novel immediate-release amphetamine prodrug protected by the Company's proprietary"

A prodrug is an inactive or less-active compound that is designed to be converted into an active drug inside the body, like a packaged meal that needs heating before it's ready to eat. For investors, prodrugs matter because this design can improve how a medicine is absorbed, reduce side effects, extend patent protection, or enable new dosing forms — all factors that can affect a drug's regulatory path, marketability, and commercial value.

notice of allowance regulatory

"today announced it received a Notice of Allowance from the European Patent Office"

A notice of allowance is an official confirmation from a patent office that a patent application has met all necessary requirements and is approved for granting. It signals that the invention is likely to receive legal protection soon, which can be important for investors considering the value and exclusivity of a new product or technology. Think of it as a green light indicating that the invention is on track to become legally protected.

european patent office regulatory

"received a Notice of Allowance from the European Patent Office for the issuance of a patent*"

The European Patent Office is the regional agency that examines and grants patents valid in many European countries under a common system. For investors, EPO patents are important because they can give a company time-limited exclusive rights to an invention, acting like a legal lock that can protect market share, enable licensing income, and signal technical strength or reduced competition. Patent grants and rejections can materially affect a company’s value and future revenue prospects.

composition of matter regulatory

"covering both composition of matter and method of use claims, adds to the Ensysce patent"

Composition of matter describes the specific chemical makeup and structure of a substance — essentially the “recipe” of which atoms or molecules are present and how they are arranged. For investors, it matters because that precise recipe is what patents, regulatory approvals, and product claims protect; control over a unique composition can create market exclusivity, influence manufacturing costs, and drive a company’s valuation or licensing potential.

AI-generated analysis. Not financial advice.

~ New ADHD pipeline leverages TAAP™ and MPAR® technologies to improve safety for patients ~

SAN DIEGO, CALIFORNIA / ACCESS Newswire / January 8, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for novel therapeutics while reducing the potential for abuse and overdose, today announced it received a Notice of Allowance from the European Patent Office for the issuance of a patent* for PF8026, a groundbreaking Attention-Deficit/Hyperactivity Disorder (ADHD) therapy. PF8026 is a novel immediate-release amphetamine prodrug protected by the Company's proprietary TAAP™ (Trypsin Activated Abuse Protection) and MPAR^® (Multi-Pill Abuse Resistance) technologies.

This newly allowed patent, covering both composition of matter and method of use claims, adds to the Ensysce patent portfolio and secures its subject-matter authority in developing safer treatments for ADHD, a condition affecting millions of children and adults worldwide.

Amphetamine stimulants remain the standard of care for ADHD but carry well-documented risks of abuse, dependence, and overdose. Approximately 3.9 million people aged 12 or older misused prescription stimulants in 2023.** PF8026 represents another drug candidate in a new class of ADHD medications that directly address these risks. Unlike traditional formulations, Ensysce's prodrug design prevents common abuse routes such as nasal inhalation and incorporates MPAR^® overdose protection that has been validated in clinical studies. With PF8026 (immediate release) and PF8001 (extended release) in its ADHD pipeline of TAAP products, Ensysce is expanding its product portfolio to include the first abuse-deterrent, overdose-protected stimulant therapies.

"Applying MPAR^® technology to ADHD medications has the potential to save lives by reducing overdose," said Dr. Richard Dart, Director of the Rocky Mountain Poison and Drug Center, a leading expert in emergency medicine and toxicology.

"Our mission has always been to deliver safer, more effective therapies in areas of urgent medical need," said Dr. Lynn Kirkpatrick, CEO of Ensysce Biosciences. "This patent strengthens our ADHD program and underscores the transformative potential of our TAAP™ and MPAR^® platforms, recognized by support from the National Institute on Drug Abuse, and brings us closer to a future where patients with ADHD, pain, or opioid use disorder can be treated effectively without the devastating risks of misuse or overdose."

* 'Compositions Comprising Enzyme-Cleavable Amphetamine Prodrugs and Inhibitors Thereof'

**https://www.samhsa.gov/data/sites/default/files/reports/rpt47095/National%20Report/National%20Report/2023-nsduh-annual-national.pdf

About Ensysce Biosciences

Ensysce Biosciences is a clinical stage company with a goal of disrupting the analgesic landscape by introducing a new class of highly novel opioids for the treatment of severe pain. Leveraging its Trypsin-Activated Abuse Protection (TAAP^TM) and Multi-Pill Abuse Resistance (MPAR^®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. For more information, please visit www.ensysce.com.

Forward-Looking Statements

Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as "may," "intends," "can," "might," "will," "expect," "plan," "possible," "believe" and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking statements are based on estimates and assumptions by Ensysce's management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected. In addition, Ensysce's business is subject to additional risks and uncertainties, including among others, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce's product candidates; the availability or commercial potential of product candidates; the ability of Ensysce to fund its continued operations, including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce's and its partners' ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of material risks and uncertainties that are described in Ensysce's most recent quarterly report on Form 10-Q and current reports on Form 8-K, which are available, free of charge, at the SEC's website at www.sec.gov. Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law.

Ensysce Biosciences Company Contact:
Lynn Kirkpatrick, Ph.D.
Chief Executive Officer
(858) 263-4196

Ensysce Biosciences Investor Relations Contact:
Shannon Devine
MZ North America
Main: 203-741-8811
ENSC@mzgroup.us

SOURCE: Ensysce Biosciences Inc.

View the original press release on ACCESS Newswire

FAQ

What did Ensysce (ENSC) announce on January 8, 2026 about PF8026?

Ensysce announced a European Patent Office Notice of Allowance for PF8026, covering composition and method of use claims for an abuse‑protected amphetamine prodrug.

How do TAAP™ and MPAR® technologies affect PF8026's safety profile for ENSC?

TAAP™ is designed to prevent common abuse routes and MPAR® provides overdose protection; the release states MPAR® has been validated in clinical studies.

Does the Ensysce announcement say PF8026 is available to patients now?

No; the announcement describes a patent allowance and pipeline status but does not state regulatory approval or commercial availability.

What other ADHD product is in Ensysce's pipeline alongside PF8026 (ENSC)?

The company lists PF8001 as an extended‑release TAAP product in its ADHD pipeline.

Why is the PF8026 patent significant for Ensysce shareholders (ENSC)?

The allowed patent expands Ensysce's intellectual property covering an abuse‑protected amphetamine prodrug, strengthening subject‑matter authority for its ADHD program.