Annovis Bio Gets FDA Nod For Late-Stage Parkinson Disease Study Amendments

The United States Food and Drug Administration (FDA) announced clearance for amendments to Annovis Bio’s ANVS Phase 3 clinical study of Buntanetap for the treatment of Parkinson's disease.

The company requested consideration from the FDA on amending the accepted development plan, finalizing the protocol for the Phase 3 study, and proceeding with longer duration clinical trials.

The regulatory agency has accepted the final protocol and the clinical development plan.

Maria L. Maccecchini, Founder, President, and CEO, said, "We are pleased that the FDA has approved our clinical trial design in early PD patients and called it a well-designed study. The positive FDA review affirms the Company's path to securing approval for buntanetap to treat neurodegenerative diseases, including Parkinson's and Alzheimer's diseases, with longer treatment regimens." 

Annovis Bio completed successful Type B meeting with FDA earlier this year on the developments of buntanetap in Parkinson's disease

Price Action: Annovis Bio shares are trading about 8 percent high at $14.39 on Thursday at the time of publication.