CervoMed nakahanay sa FDA sa disenyo ng Phase 3 para sa neflamapimod sa DLB

Nakuha ng CervoMed ang pagkakahanay sa FDA at pandaigdigang regulator sa isang solong, pandaigdigang, randomized, double-blind, placebo-controlled Phase 3 trial design sa ~300 pasyenteng may DLB na walang AD co-pathology; gagamitin ng trial ang bagong napiling 50 mg TID stable-crystal formulation at susuriin ang CDR-SB bilang primary endpoint. Plano na ngayon ng kumpanya na simulan ang pivotal study na ito sa ikalawang kalahati ng 2026, depende sa financing, na nagmamarka ng malinaw na pag-unlad sa regulatory path para sa neflamapimod.

Mahahalagang fact

Na-file: Mar 17, 2026, 08:31 PM
Kaganapan: Pagbabago sa trial registry
Direksyon: Positibo
Kumpanya: CRVOCervoMed Inc.
Asset: neflamapimod
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

EX-99.1 2 ex_933983.htm EXHIBIT 99.1 ex_933983.htm Exhibit 99.1 CervoMed Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Updates Reported positive Phase 2b RewinD-LB clinical data at CTAD 2025; additional analyses to be presented at AD/PD 2026 Obtained alignment with FDA and global regulators for planned Phase 3 trial design in patients with DLB and selected Phase 3 formulation, dose and dosing regimen Multiple potential catalysts anticipated in the second half of 2026, including initiation of the planned Phase 3 trial, topline data from Phase 2a ischemic stroke recovery trial, initial topline data from Phase 2a primary progressive aphasia trial, and initiation of EXPERTS-ALS trial in Amyotrophic Lateral Sclerosis BOSTON, March 17, 2026 — CervoMed

SEC 8-K