Annovis Bio wins FDA nod to begin late-stage study for Parkinson's candidate

Grandbrothers/iStock Editorial via Getty Images

• Clinical-stage biotech Annovis Bio (NYSE:ANVS) added ~10% in the pre-market Thursday after the company announced that the FDA gave the go-ahead to a Phase 3 trial for oral experimental therapy buntanetap for the treatment of Parkinson's disease.
• Chief Executive Maria L. Maccecchini announced that the company will start recruitment of early Parkinson's disease patients for the study later this summer.
• "With this FDA notice in hand, we are thrilled to start recruiting for the US clinical trial soon, expected later this summer," Maccecchini noted.
• Following a Type B meeting earlier this year, the regulator has accepted the final protocol and the clinical development plan for buntanetap, Annovis (ANVS) said.
• In addition, the FDA has greenlighted the use of the company’s new batch of good manufacturing practice material.
• The agency has noted that toxicology data for buntanetap based on animal studies would support human studies for the long term compared to the previous restriction of one month.
• In terms of current analyst ratings, Annovis (ANVS) commands a Strong Buy recommendation on Wall Street.

Comments

[dealripper]

Great news! Now lets see it reflected in the price action

[Totenpole]

@dealripper ...sustainably

[TJ Burke]

Bought in a few weeks ago - working so far. Finish line still far off - as with SAVA and AVXL

[PFD]

Following