Ensysce Biosciences Inc Stock Price, News & Analysis

Ensysce Biosciences (NASDAQ:ENSC) issued its 2025 annual shareholder letter outlining clinical, regulatory, IP and financing progress. Key 2025 achievements include initiation of the pivotal PF614-301 Phase 3 trial with enrollment started at two sites, FDA alignment on PF614 commercial manufacturing and CMC strategy, and advancement of PF614-MPAR under Breakthrough Therapy pathway. The company secured additional capital including a November 2025 $4M convertible preferred financing enabling access to up to $20M over 24 months and continued non-dilutive support from NIDA totaling over $25M for MPAR programs. A new MPAR patent allowance extends protection through 2042. Anticipated 2026 priorities include continued Phase 3 enrollment, further FDA interactions, MPAR labeling work, and PF9001 IND-enabling activities.

Ensysce Biosciences (NASDAQ:ENSC) announced the enrollment of the first patient in its pivotal Phase 3 trial of PF614 on December 9, 2025. The study, PF614-301, is a multicenter, randomized, double‑blind, placebo‑ and active‑controlled trial evaluating PF614 for moderate to severe pain after abdominoplasty.

The trial will test twice‑daily dosing intended to provide consistent post‑surgical analgesia while incorporating an innovative chemical mechanism designed to reduce abuse and overdose risk. Initial sites include CenExel JBR in Salt Lake City and CenExel Atlanta under principal investigators Dr. Todd Bertoch and Dr. Jessica McCoun.

Ensysce Biosciences (NASDAQ:ENSC) announced a U.S. Notice of Allowance for a new patent covering its MPAR® overdose protection technology, extending MPAR patent coverage through 2042. The patent titled "Compositions Comprising Enzyme-Cleavable Prodrugs and Controlled Release Nafamostat and Methods of Use Thereof" includes composition-of-matter and method-of-use claims to strengthen the company’s IP estate. MPAR earned Breakthrough Therapy Designation from the FDA in January 2025. Clinical testing of PF614-MPAR reportedly showed effective pain relief when taken as prescribed and reduced excessive opioid delivery when multiple doses were taken. Ensysce is also applying MPAR to other drug classes and is conducting a second clinical trial to further evaluate the technology.

Ensysce Biosciences (NASDAQ:ENSC) announced on November 20, 2025 that the FDA provided written responses agreeing with Ensysce's proposed manufacturing approach for PF614, including regulatory starting materials and drug substance specifications.

The FDA feedback gives Ensysce a direct path to commercial production; commercial-scale manufacturing has been initiated with partner Purisys, LLC (a Noramco subsidiary). Management said the guidance supports scaling PF614, the company’s TAAP oxycodone analogue, toward market rollout for moderate-to-severe pain.

Ensysce Biosciences (NASDAQ:ENSC) closed a $4.0 million convertible preferred financing on November 17, 2025, with the potential for up to an additional $16.0 million in future tranches over the next 24 months (up to $20.0 million total).

The initial tranche carries a fixed conversion price of $2.50 per share, an alternate conversion based on average common stock prices, and 50% warrant coverage exercisable at the fixed conversion price for five years. Proceeds will accelerate the Phase 3 development of PF614 and support corporate initiatives, with management citing Phase 3 completion or market-readiness targets in the 18–24 month timeframe.

Ensysce Biosciences (NASDAQ:ENSC) reported Q3 2025 results and operational milestones on November 14, 2025. Key developments include the initiation of the pivotal Phase 3 PF614-301 trial in July 2025, FDA Breakthrough Therapy designation support for PF614-MPAR, and engagement of Rho, Inc. to run the pivotal study.

Financial highlights: cash $1.7M at Sept 30, 2025; completed a $4M convertible preferred stock financing in November with up to $16M additional tranches available; Q3 federal grant funding $0.5M (vs $3.4M a year ago); R&D $3.0M (Q3 2025) and net loss $3.7M (Q3 2025).

Ensysce Biosciences (NASDAQ:ENSC) released video highlights from its PAINWeek 2025 symposium titled "Pain Management, RE-Invented: A New Era for Analgesia", held in Las Vegas on September 3, 2025. The symposium featured medical and scientific leaders discussing challenges in pain treatment and Ensysce's proprietary platforms TAAP™ and MPAR®, which aim to reduce opioid misuse and overdose while preserving analgesia. Video highlights with expert commentary and real-world perspectives are available on the Ensysce Media/Science Center at www.ensysce.com.

The company said it continues advancing its portfolio toward commercialization with the goal of safer severe-pain management.

Ensysce Biosciences (NASDAQ:ENSC) hosted a well-attended symposium titled "Pain Management, RE-Invented: A New Era for Analgesia" at PAINWeek 2025 in Las Vegas. The symposium, which drew approximately 400 attendees, featured presentations from leading pain medicine experts highlighting the company's innovative TAAP™ and MPAR® technologies.

The event showcased Ensysce's approach to developing safer opioids, featuring their lead candidate PF614. The technology uniquely uses the body's chemistry to activate pain relief with proper dosing while preventing overdose. Dr. William Schmidt presented data on PF614 and outlined plans for an upcoming Phase 3 trial in acute post-surgical pain.

Ensysce Biosciences (NASDAQ:ENSC) announced that Chief Commercial Officer Geoff Birkett will chair the Fierce New Product Planning Summit 2025, scheduled for September 8-11, 2025, in Philadelphia. Birkett will deliver opening remarks and present a case study on successful product launches.

The summit focuses on helping product planning teams make informed, value-based decisions for commercial success. At Ensysce, Birkett is leading the launch preparations for PF614, the company's first-in-class analgesic designed to combat severe pain while reducing abuse and overdose risks.

Birkett brings extensive experience from leadership roles at Eli Lilly, Lundbeck, and AstraZeneca, where he successfully launched several groundbreaking medicines in pain, addiction, and neuroscience.