Ensysce Biosciences Stock Price, News & Analysis

Ensysce Biosciences, Inc. (NASDAQ: ENSC) is a clinical-stage pharmaceutical company focused on developing prescription therapeutics designed to treat severe pain and other central nervous system conditions while reducing the risks of opioid and stimulant abuse, dependence, and overdose. The company describes its goal as disrupting the analgesic landscape by introducing a new class of highly novel opioids for the treatment of severe pain, and extending its technology to areas such as Attention-Deficit/Hyperactivity Disorder (ADHD) and opioid use disorder (OUD).

Ensysce operates in the pharmaceutical preparation manufacturing industry and is advancing a pipeline built around two proprietary technology platforms: Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®). These platforms are intended to create tamper-resistant prodrugs that use the body’s own chemistry to control when and how active drug is released, with the aim of limiting common routes of abuse and providing built-in overdose protection.

Core Technology Platforms

TAAP™ (Trypsin-Activated Abuse Protection) is a prodrug technology that chemically modifies existing active ingredients, such as oxycodone or amphetamine, so that they remain inactive until swallowed and exposed to trypsin in the small intestine. According to company disclosures, this design is intended to make products highly resistant to tampering and to reduce abuse through non-oral routes of administration, while still providing effective pain relief or therapeutic benefit when taken as prescribed.

MPAR® (Multi-Pill Abuse Resistance) is an overdose protection platform that pairs enzyme-cleavable prodrugs with a controlled-release trypsin inhibitor. In overdose scenarios where multiple doses are taken, MPAR® is designed to limit or “switch off” further release of the active opioid, thereby moderating drug exposure. Company-reported clinical data with PF614-MPAR indicate that the technology can provide effective pain relief at prescribed doses while reducing excessive opioid delivery when higher-than-prescribed amounts are taken.

Ensysce reports that MPAR® has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), and that a Notice of Allowance for a new MPAR® patent extends intellectual property protection for this platform through 2042. The company states that its intellectual property estate includes composition-of-matter and method-of-use claims for its overdose protection technology.

Lead Pain Management Programs

The company’s lead clinical candidate is PF614, described as a TAAP™ extended-release oxycodone analogue and a potential “next generation” analgesic to treat severe pain. PF614 is engineered so that the modified oxycodone remains inactive until it is swallowed and exposed to trypsin in the small intestine, at which point it is “switched on” to release oxycodone. Ensysce states that this mechanism is designed to control release when administered orally, make the product highly resistant to tampering, and reduce abuse risk, with the goal of providing what it believes is a safer opioid option for patients who require opioid-strength analgesia.

Ensysce has initiated a pivotal Phase 3 clinical trial, PF614-301, described as a multicenter, randomized, double-blind, placebo- and active-controlled study evaluating the efficacy and safety of PF614 for the treatment of moderate to severe pain following abdominoplasty. The study is designed to assess PF614’s ability to deliver steady post-surgical pain relief while addressing safety concerns associated with traditional opioids, including abuse potential and fluctuations in blood drug concentrations.

The company is also developing PF614-MPAR, a combination product that integrates the TAAP™ prodrug PF614 with MPAR® overdose protection. PF614-MPAR is intended to treat severe pain while adding oral overdose protection by reducing or switching off opioid release when doses exceed prescribed limits. Ensysce reports that initial clinical trial data (PF614-MPAR-101) demonstrated the desired overdose protection at a specified dose and that this program is advancing under FDA Breakthrough Therapy designation with support from multi-year grants from the National Institute on Drug Abuse (NIDA).

Expansion into ADHD and Opioid Use Disorder

Beyond pain, Ensysce is applying its TAAP™ and MPAR® technologies to other therapeutic areas. In ADHD, the company has disclosed development of PF8026, a novel immediate-release amphetamine prodrug that incorporates both TAAP™ and MPAR® features. PF8026 is designed to provide ADHD treatment while addressing risks of abuse, dependence, and overdose associated with traditional stimulant medications. The company has received a Notice of Allowance from the European Patent Office for PF8026, covering composition-of-matter and method-of-use claims, and identifies PF8026 and PF8001 (an extended-release ADHD candidate) as part of an ADHD pipeline of TAAP™ products.

In the area of opioid use disorder, Ensysce has identified PF9001 as its lead OUD candidate. According to company communications, PF9001 leverages both TAAP™ and MPAR® technologies and is being evaluated as an oral therapy intended to limit abuse, reduce cardiovascular risk, and incorporate built-in overdose protection. This program is supported by a multi-year grant under the HEAL (Helping to End Addiction Long-term) initiative, with encouragement from NIDA, and is progressing toward non-clinical studies to support a future Investigational New Drug (IND) application.

Regulatory, Clinical, and Intellectual Property Milestones

Ensysce highlights several regulatory and clinical milestones across its programs. For PF614, the company reports constructive written feedback from the FDA on its commercial manufacturing strategy, including agreement on regulatory starting materials, drug substance specifications, and overall chemistry, manufacturing, and controls (CMC) approach. This alignment is described as providing a direct path to commercial-scale production, with manufacturing activities initiated through partners such as Purisys, LLC and Galephar.

For PF614-MPAR, Ensysce reports ongoing dialogue with the FDA regarding overdose protection labeling and support for a streamlined 505(b)(2) registration pathway. The company also notes collaborative work with the FDA on a scientific whitepaper to articulate the rationale behind overdose protection labeling, and continued advancement of the PF614-MPAR-102 clinical study funded by NIDA grants.

On the intellectual property front, Ensysce has announced a Notice of Allowance from the U.S. Patent and Trademark Office for a patent titled “Compositions Comprising Enzyme-Cleavable Prodrugs and Controlled Release Nafamostat and Methods of Use Thereof,” which extends MPAR® patent coverage through 2042. In Europe, the company has received a Notice of Allowance for a patent related to PF8026, further broadening its patent portfolio in ADHD.

Financing and Capital Structure

As a clinical-stage company, Ensysce finances its operations through a combination of equity offerings and non-dilutive grant funding. The company has reported multiple preferred stock financings and registered direct offerings, including a convertible preferred stock financing that provides an initial tranche of capital with the potential for additional funding over a defined period. An 8-K filing dated November 17, 2025 describes a Securities Purchase Agreement for Series B Preferred Stock and related warrants, with gross proceeds from a registered direct offering and a concurrent private placement, and outlines terms such as conversion prices, warrant exercise prices, and an exchange cap under Nasdaq rules.

Ensysce also reports significant non-dilutive support from NIDA and other federal programs. According to company disclosures, the MPAR® program has received multi-year grant funding, with total non-dilutive support for PF614-MPAR exceeding tens of millions of dollars, and the OUD program supported by a HEAL grant. These grants are used to fund clinical and non-clinical research activities aligned with the company’s focus on abuse- and overdose-resistant therapeutics.

Business Focus and Segment

Ensysce states that it operates in one business segment, pharmaceuticals, with a focus on next-generation pain and central nervous system therapeutics. Its pipeline centers on prodrug-based opioids and related compounds that incorporate intrinsic safeguards against tampering, misuse, and overdose. The company characterizes its mission as advancing safer, more responsible opioid analgesics and related therapies without compromising access to effective treatment for patients with severe pain or other serious conditions such as ADHD and opioid use disorder.

Stock Information

Ensysce Biosciences, Inc. lists its common stock on The Nasdaq Stock Market LLC under the trading symbol ENSC. The company has filed shelf registration statements and related prospectus supplements to support its capital-raising activities, as described in its SEC filings.

FAQs about Ensysce Biosciences, Inc. (ENSC)

• What does Ensysce Biosciences do?
  Ensysce Biosciences is a clinical-stage pharmaceutical company developing prescription therapeutics for severe pain and other central nervous system conditions. Its programs are built on TAAP™ and MPAR® technologies, which are designed to reduce the risk of drug abuse and overdose while maintaining therapeutic efficacy.
• What are TAAP™ and MPAR® technologies?
  TAAP™ (Trypsin-Activated Abuse Protection) is a prodrug platform that keeps medications inactive until they are swallowed and exposed to trypsin in the small intestine, aiming to deter tampering and non-oral abuse. MPAR® (Multi-Pill Abuse Resistance) is an overdose protection platform that uses controlled-release trypsin inhibitors to limit drug release when multiple doses are taken, with the goal of moderating exposure in overdose situations.
• What is PF614?
  PF614 is Ensysce’s lead clinical candidate, described as a TAAP™ extended-release oxycodone analogue for the treatment of moderate to severe pain. It is designed to activate only after oral ingestion and exposure to trypsin, with the intent of providing steady pain relief while reducing abuse potential and resistance to tampering.
• How does PF614-MPAR differ from PF614?
  PF614-MPAR combines the PF614 prodrug with MPAR® overdose protection. While PF614 focuses on abuse deterrence through TAAP™, PF614-MPAR adds a mechanism intended to reduce or switch off opioid release when doses exceed prescribed levels, providing an additional layer of safety in overdose scenarios.
• Is Ensysce working on therapies beyond pain management?
  Yes. Ensysce is developing TAAP™ and MPAR®-based candidates for ADHD, including PF8026, an immediate-release amphetamine prodrug, and PF8001, an extended-release ADHD candidate. The company is also advancing PF9001 as a lead candidate for opioid use disorder, supported by a HEAL grant and NIDA encouragement.
• What regulatory designations has Ensysce reported?
  Ensysce reports that its MPAR® overdose protection platform has received Breakthrough Therapy designation from the FDA, and that PF614-MPAR is advancing under this designation. The company also notes constructive FDA feedback on PF614 manufacturing and regulatory pathways for overdose protection labeling.
• How is Ensysce funding its development programs?
  Ensysce funds its programs through a mix of equity financings and non-dilutive federal grants. SEC filings describe preferred stock and warrant offerings, while company communications highlight multi-year NIDA and HEAL grants that support the MPAR® and OUD programs.
• What exchange does ENSC trade on?
  Ensysce Biosciences’ common stock trades on The Nasdaq Stock Market LLC under the ticker symbol ENSC, as indicated in its SEC filings.