Ensysce Initiates PF614 Phase 3 Enrollment, Advancing Towards Commercialization
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 12 2025
0mins
Source: Newsfilter
- Clinical Milestone: Ensysce Biosciences announced the enrollment of the first patient in the PF614 Phase 3 study, marking a significant step towards commercialization, which is expected to enhance its competitiveness in the safer opioid market.
- IP Expansion: The newly granted U.S. patent extends the protection of Ensysce's MPAR® overdose-prevention platform until 2042, strengthening the company's competitive moat in opioid safety and supporting its future market positioning.
- FDA Regulatory Milestone: The FDA's agreement on PF614's Chemistry, Manufacturing, and Controls strategy provides a clear pathway to commercial production, reducing regulatory risks and enhancing Ensysce's competitiveness at key clinical and regulatory inflection points.
- Financing Strengthens Capital: Ensysce closed a $4 million convertible preferred stock financing, with potential access to an additional $16 million, significantly enhancing the company's financial flexibility to support PF614's Phase 3 development and other initiatives.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy ENSC?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on ENSC
About ENSC
Ensysce Biosciences, Inc. is a clinical-stage pharmaceutical company. The Company develops solutions for severe pain relief while reducing the potential for opioid misuse, abuse, and overdose. Its pipeline includes two new drug platforms: an abuse-resistant opioid prodrug technology, the Trypsin Activated Abuse Protection (TAAP) platform, and an over-dose protection opioid prodrug technology, the Multi-Pill Abuse Resistant (MPAR) platform. Its lead product, PF614, is a TAAP extended-release oxycodone and a potential analgesic to treat severe pain. Its second product, PF614-MPAR, is to treat severe pain with the added benefit of oral overdose protection, is a combination product of the TAAP prodrug PF614 with a trypsin inhibitor. Additionally, nafamostat, which is an ingredient in its overdose protection combination products, is also being developed for the intended purpose of treating infection and pulmonary lung diseases.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Ensysce Secures Brazilian Patent to Advance Safer Opioid Treatments
- Patent Approval: Ensysce received a Notice of Allowance from the Brazilian Patent Office for its TAAP™ and MPAR® technologies applied to additional opioid families, further strengthening its intellectual property and supporting the global development of safer analgesics.
- Technological Innovation: The application of MPAR® technology in Ensysce's opioids is expected to significantly reduce abuse potential and prevent overdose, enhancing patient safety without compromising pain relief, showcasing the transformative potential of its platforms.
- Market Expansion: This patent not only extends Ensysce's protection in North America and the EU but also strengthens its competitive position in the South American market, aiding the company's global strategy in the analgesic sector.
- Strategic Vision: Ensysce's CEO highlighted that this patent approval complements its recent patent for ADHD and opioid use disorder products, marking a significant step towards developing safer and more effective therapeutic options.
Continue Reading
Ensysce Initiates PF614 Phase 3 Enrollment, Advancing Towards Commercialization
- Clinical Milestone: Ensysce Biosciences announced the enrollment of the first patient in the PF614 Phase 3 trial, marking a significant step towards commercialization and expected to enhance its competitive position in the safe opioid market.
- IP Expansion: The newly granted U.S. patent extends the protection for Ensysce's MPAR® overdose-prevention platform until 2042, strengthening the company's competitive moat in the field of safe opioid therapeutics.
- Regulatory Milestone: The FDA's endorsement of PF614's Chemistry, Manufacturing, and Controls strategy provides a clear pathway for commercial-scale production, reducing regulatory risks and enhancing the likelihood of successful approval.
- Capital Financing: Ensysce secured $4 million in convertible preferred stock financing, with the potential for an additional $16 million, significantly enhancing the company's financial flexibility as it advances the PF614 Phase 3 program.
Continue Reading