8-K - CervoMed Inc. | StockGist

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CervoMed Inc. issued a press release announcing new analyses from its Phase 2b RewinD-LB trial of neflamapimod in dementia with Lewy bodies patients, showing greater clinical benefits in subgroups with lower plasma pTau181 levels indicating absence of Alzheimer’s co-pathology. These data support neflamapimod’s potential mechanism, patient enrichment strategy using pTau181 <21 pg/mL, and 50mg TID dosing for the planned Phase 3 trial.

Key Takeaways

1New RewinD-LB analyses presented at AD/PD 2026 Conference on March 21, 2026, in Copenhagen.

2In patients with pTau181 <21 pg/mL (80-90% without AD co-pathology), DP Batch B vs placebo CDR-SB difference -1.11 (p=0.005).

3Therapeutic threshold for neflamapimod: trough plasma concentration of 4 ng/mL.

4DP Batch B achieved C_trough ≥4 ng/mL in 75% of participants vs 50% for DP Batch A (p=0.02).

5Planned Phase 3 trial in DLB patients with pTau181 <21 pg/mL, 50mg TID dosing, initiation in second half of 2026 subject to funding.

6RewinD-LB trial: 159 participants, funded by $21.3 million NIH grant.

Current Report Details

Event Type

Regulation Fd

Other Event

Disclosure

Voluntary

Variant

8-K

Items Reported

7.01

of this Current Report on Form 8-K. -- The information in this Item 7.01 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Se

Regulation Fd

8.01

of this Current Report on Form 8-K. Item 9.01 Financial Statements and Exhibits (d) Exhibits Exhibit No. Description 99.1 Press Release, issued March 19, 2026 1

Other Event

Exhibits (2)

8-K

FORM 8-K

99.1

EXHIBIT 99.1