Annovis Bio Secures FDA Meeting to Advance Parkinson's Disease Dementia Treatment

Annovis Bio Inc. (NYSE: ANVS), a late-stage clinical drug platform company developing therapies for neurodegenerative diseases, has secured a Type C meeting with the U.S. Food and Drug Administration scheduled for January 2026 to discuss the clinical pathway for buntanetap in Parkinson's disease dementia. The company simultaneously reaffirmed continued progress in its Phase 3 Alzheimer's trial, which remains in full regulatory alignment on design, endpoints and patient population. This regulatory milestone represents significant advancement for the Parkinson's disease dementia program and underscores the company's parallel progress across multiple neurodegenerative disease indications.

CEO Maria Maccecchini characterized the FDA meeting as an important milestone for the Parkinson's disease dementia program, emphasizing the strategic importance of this regulatory engagement. Senior Vice President Cheng Fang noted that strong data across both Alzheimer's and Parkinson's studies highlights buntanetap's potential to address a major unmet medical need for cognitive decline in Parkinson's patients. The company's dual focus on both Alzheimer's disease and Parkinson's disease dementia positions it to potentially address significant gaps in treatment options for millions of patients suffering from neurodegenerative conditions worldwide.

The Type C meeting represents a formal opportunity for Annovis Bio to engage with FDA regulators specifically about the development pathway for buntanetap in Parkinson's disease dementia. These regulatory discussions typically focus on specific issues related to drug development and can provide critical guidance for clinical trial design and regulatory strategy. The timing in January 2026 allows the company to continue gathering clinical data while preparing for this important regulatory interaction. Additional information about the company's development programs is available at https://www.annovisbio.com.

While advancing the Parkinson's disease dementia program, Annovis Bio maintains that its Phase 3 Alzheimer's trial continues to progress with full regulatory alignment. This parallel development approach demonstrates the company's strategy to address multiple neurodegenerative conditions with its lead compound buntanetap. The compound's mechanism of action targets multiple neurodegenerative pathways, potentially offering broad therapeutic applications across different conditions characterized by cognitive decline and neurological impairment. Investors can access the latest company updates through the newsroom at https://ibn.fm/ANVS.

The announcement comes at a time when the medical community continues to seek effective treatments for Parkinson's disease dementia, a condition that affects a significant portion of Parkinson's patients as their disease progresses. Current treatment options remain limited, creating substantial unmet medical need in this patient population. The company's progress in both Alzheimer's and Parkinson's disease dementia programs suggests potential for buntanetap to address cognitive symptoms across multiple neurodegenerative conditions, though clinical outcomes will depend on results from ongoing and future clinical trials.