FDA Lifts Exposure Cap, New Tablet Enables Higher Neflamapimod Dosing
CRVO sits 24% above its 52-week low of $2.13 on light trading volume (0.3× avg).
Summary
CervoMed announced a new 50 mg tablet formulation of neflamapimod with a PK profile better suited for twice-daily dosing, and the FDA removed the prior plasma drug exposure limit after a 39-week dog toxicology study showed a NOAEL three-fold higher than prior studies. The company plans to advance a 100 mg BID regimen expected to increase trough concentrations by ~33% versus the 40 mg TID used in Phase 2a/2b, while lowering Cmax by ~20% relative to the old capsule. This addresses the formulation variability seen in the Phase 2b RewinD-LB study and reduces CMC risk with a controlled manufacturing process. The news follows the UK Innovation Passport granted in August and the completed enrollment in the Phase 2a nfvPPA trial, with interim biomarker data expected in early Q4 2026. The higher trough levels are designed to improve efficacy without increasing peak-related safety issues, a key step toward a Phase 3 in DLB pending a strategic partner.
Updates
· SEC 8-K — The 8-K attaches the press release announcing the new 50 mg tablet, FDA removal of the exposure limit, and planned 100 mg BID regimen.
At the time of this announcement, CRVO was trading at $2.64 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $38.4M. The 52-week trading range was $2.13 to $10.00. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.