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成立时间
1984
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- Ensysce Biosciences initiated enrollment for its pivotal PF614-301 Phase 3 trial in December 2025, evaluating the abuse-resistant oxycodone analgesic for post-surgical pain management. - The FDA provided positive feedback on Ensysce's commercial manufacturing strategy for PF614, agreeing with proposed regulatory starting materials and specifications to enable commercial-scale production. - The company secured up to $20 million in funding through November 2025 and extended MPAR® patent protection through 2042, strengthening its intellectual property portfolio. - PF614-MPAR continues advancing under FDA Breakthrough Therapy designation with over $25 million in NIDA grant funding supporting overdose protection technology development.
- Pridopidine demonstrated significant benefits on clinical progression, cognition, and motor function in Huntington's disease patients not taking antidopaminergic medications during the PROOF-HD phase 3 trial. - The investigational therapy showed sustained efficacy for up to two years, with meaningful improvements in composite UHDRS scores, slowing disease decline compared to placebo. - Pridopidine's safety and tolerability profile was comparable to placebo, offering potential hope in a disease landscape with no current curative options.
