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Annovis Announces FDA Meeting to Discuss Parkinson's Disease Dementia Program; Reaffirms FDA Alignment on Pivotal Phase 3 Alzheimer's Disease Study
MALVERN, Pa., Nov. 18, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced that the U.S. Food and Drug Administration (FDA) has scheduled a Type C meeting in January 2026 to discuss the Company's pathway for Parkinson's disease dementia (PDD). Annovis also reaffirmed that its
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[{"type":"image","alt":"Annovis Bio Inc.","displaySize":"","headline":null,"caption":"Annovis Bio Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":200,"height":200,"url":"https://media.zenfs.com/en/globenewswire.com/00e49d5ebf66ac512dbaabeac6cdd6eb"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/plvHQ2cwqCYZbJvLkT5mUA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTM2MDtoPTM2MDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/00e49d5ebf66ac512dbaabeac6cdd6eb","width":200,"height":200}},"lazy":false},{"type":"text","content":"MALVERN, Pa., Nov. 18, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced that the U.S. Food and Drug Administration (FDA) has scheduled a Type C meeting in January 2026 to discuss the Company's pathway for Parkinson's disease dementia (PDD). Annovis also reaffirmed that its ongoing Phase 3 AD clinical trial continues to progress with full regulatory alignment on study design, endpoints, and patient population.","length":655,"tagName":"p"},{"type":"text","content":""We are pleased with such proactive engagement with the FDA on our PDD program, which represents a significant opportunity to address an underserved patient population," said Maria Maccecchini, Ph.D., President and CEO. "The scheduled January meeting marks a key milestone for our pipeline, underscoring buntanetap's potential across multiple neurodegenerative indications and the strength of our scientific approach."","length":442,"tagName":"p"},{"type":"text","content":"Parkinson's Disease Dementia Program","length":40,"tagName":"p"},{"type":"text","content":"The upcoming meeting will focus on the clinical development pathway for buntanetap in PDD, a debilitating condition affecting approximately 30% of PD patients, with some reports suggesting that up to 80% develop dementia over the long term. Dementia in Parkinson’s profoundly affects quality of life for both patients and caregivers, with limited approved treatment options currently available. The meeting agenda will include discussions on clinical trial design, patient population, and a potential approval route.","length":516,"tagName":"...