ANNOVIS BIO, INC.

(ANVS)
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Delayed Nyse  -  04:00 2022-08-18 pm EDT
11.90 USD   -4.88%
08/08ANNOVIS BIO, INC. Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q)
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08/08Annovis Bio, Inc. Reports Earnings Results for the Second Quarter and Six Months Ended June 30, 2022
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08/08ANNOVIS BIO : Announces Second Quarter 2022 Results and Provides Corporate Update - Form 8-K
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Annovis Bio Shares Rise 8% After FDA Allows Buntanetap Trial to Proceed

07/07/2022 | 08:21am EDT

By Chris Wack


Annovis Bio Inc. shares were up 8% to $14.30 after the company said it has received notice from the U.S. Food and Drug Administration that its Phase 3 clinical study of buntanetap in early Parkinson's patients may proceed.

The stock ended Wednesday's session up 7%, but is still down 18% year-to-date.

The company said the FDA accepted the final protocol and the clinical development plan, approved the use of the company's new large-scale batch of good manufacturing practice material, and found the chronic toxicology in rats and dogs safe and adequate to support long-term human studies lasting decades compared to the previous restriction of one month.

Following a successful Type B meeting for the continued development of buntanetap in Parkinson's disease with the FDA earlier this year, 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 company submitted all the safety data in mice, rats, dogs and more than 200 humans, the chemistry, manufacturing, and controls package for the new large-scale batch, and all the data accumulated over the years for the company's Alzheimer's disease program that also pertained to Parkinson's disease program.

The company plans to start recruiting for a U.S. clinical trial soon, expected later this summer.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

07-07-22 1021ET

All news about ANNOVIS BIO, INC.
08/08ANNOVIS BIO, INC. Management's Discussion and Analysis of Financial Condition and Resu..
AQ
08/08Annovis Bio, Inc. Reports Earnings Results for the Second Quarter and Six Months Ended ..
CI
08/08ANNOVIS BIO : Announces Second Quarter 2022 Results and Provides Corporate Update - Form 8..
PU
08/08Annovis Bio Announces Second Quarter 2022 Results and Provides Corporate Update
PR
08/01Annovis Bio to Participate on Alzheimer's Association International Conference Panel
PR
07/14Annovis Bio to Present at the Alzheimer's Association International Conference
PR
07/07SECTOR UPDATE : Health Care Stocks Gain Premarket Thursday
MT
07/07SECTOR UPDATE : Health Care
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07/07Annovis Bio Shares Rise 8% After FDA Allows Buntanetap Trial to Proceed
DJ
07/07Annovis Bio Says FDA Gives Permission to Proceed With Phase 3 Trial of Early Parkinson'..
MT
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Financials (USD)
Sales 2022 - - -
Net income 2022 -30,6 M - -
Net Debt 2022 - - -
P/E ratio 2022 -3,21x
Yield 2022 -
Capitalization 97,2 M 97,2 M -
Capi. / Sales 2022 -
Capi. / Sales 2023 -
Nbr of Employees 3
Free-Float 69,1%
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Number of Analysts 2
Last Close Price 11,90 $
Average target price 31,50 $
Spread / Average Target 165%
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Managers and Directors
Maria-Luisa Maccecchini President, Chief Executive Officer & Director
Jeffrey B. McGroarty Chief Financial Officer
Michael B. Hoffman Chairman
Cheng Fang Senior Vice President-Research & Development
Claudine E. Bruck Independent Director
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