8-K - Annovis Bio, Inc. | StockGist

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Annovis Bio, Inc. announced that an independent DSMB issued a positive safety recommendation for buntanetap at 6 months, supporting continuation of the pivotal Phase 3 Alzheimer's disease trial without modification. The trial is 40% complete, with first symptomatic efficacy readout anticipated in early 2027.

Key Takeaways

1DSMB recommended continuation of Phase 3 AD trial of buntanetap without changes after 6-month safety review

2No safety concerns identified; safety data consistent with Parkinson's patients

3Pivotal Phase 3 AD trial (NCT06709014) is 40% complete and recruiting in the US

4First symptomatic efficacy readout expected in early 2027; disease-modifying readout in early 2028

5FDA may consider combined safety data from AD and PD studies for future NDA submission

Current Report Details

Event Type

Regulation Fd

Disclosure

Voluntary

Variant

8-K

Items Reported

7.01

Regulation FD Disclosure. On February 12, 2026, Annovis Bio, Inc. issued the press release furnished herewith as Exhibit 99.1. ITEM 9.01 Financial Statements an

Regulation Fd

Exhibits (2)

8-K

FORM 8-K

99.1

EXHIBIT 99.1