Annovis Bio Secures FDA Meeting for Parkinson's Dementia Drug Development

Annovis Bio Inc. 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 also reaffirmed continued progress in its Phase 3 Alzheimer's trial, which remains in full regulatory alignment on design, endpoints and patient population. CEO Maria Maccecchini stated that the FDA meeting marks an important milestone for the Parkinson's disease dementia program. 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 need for cognitive decline in Parkinson's patients.

The announcement comes as Annovis continues to advance its neurodegenerative disease portfolio, with buntanetap showing promise across multiple indications. Parkinson's disease dementia represents a significant challenge in neurology, with limited treatment options currently available to patients experiencing cognitive decline alongside motor symptoms. The scheduled FDA meeting in early 2026 provides a clear timeline for regulatory discussions about the drug's development pathway. The Type C meeting format allows for focused discussion on specific development issues, suggesting the FDA recognizes the importance of advancing treatments for Parkinson's disease dementia.

Annovis maintains its commitment to addressing neurodegeneration in diseases such as Alzheimer's and Parkinson's through innovative therapeutic approaches. The company's dual focus on both major neurodegenerative conditions positions it to potentially address substantial patient populations facing cognitive decline. This regulatory milestone, combined with the ongoing Phase 3 Alzheimer's trial progress, indicates sustained momentum in Annovis's clinical development programs targeting neurodegenerative conditions that affect millions of patients worldwide. The company's progress can be tracked through their corporate communications available at https://ibn.fm/ANVS and additional information about the company and its development programs is available at https://www.annovisbio.com.