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MIMEDX Provides Update on AXIOFILL® Request for Designation (“RFD”) from FDA [Yahoo! Finance]

MiMedx Group, Inc (MDXG)  More Company Research Source: Yahoo! Finance
Last mimedx group, inc earnings: 4/28 07:00 am Check Earnings Report
US:NASDAQ Investor Relations: phx.corporate-ir.net/phoenix.zhtml?c=213465&p=irol-irhome
MIMEDX Continues to Pursue All Available Options to Keep AXIOFILL on the Market Reiterates Expectations for 2024 Net Sales Percentage Growth in the Low Double Digits and 2024 Adjusted EBITDA Margin Above 20% MARIETTA, Ga., March 27, 2024 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today announced that the U.S. Food and Drug Administration (“FDA”) has issued a determination letter in connection with the RFD process related to AXIOFILL, a human-derived particulate wound dressing. In the letter, FDA reaffirmed its position that AXIOFILL does not meet the regulatory classification requirements of a Human Cell, Tissue or Cellular or Tissue-based Product (“HCT/P”) under Section 361 of the Public Health Service Act (“PHSA”). Joseph H. Capper, MIMEDX Chief Executive Officer, commented: “We are disappointed that the FDA, through the RFD process, has reached a conclusion that continues an inconsistent approach to regulating AXIOFILL and other human-d [Read more]
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Stockreport

MIMEDX Provides Update on AXIOFILL® Request for Designation (“RFD”) from FDA [Yahoo! Finance]

MiMedx Group, Inc  (MDXG) 
More Company Research Source: Yahoo! Finance
Last mimedx group, inc earnings: 4/28 07:00 am Check Earnings Report
US:NASDAQ Investor Relations: phx.corporate-ir.net/phoenix.zhtml?c=213465&p=irol-irhome
MIMEDX Continues to Pursue All Available Options to Keep AXIOFILL on the Market Reiterates Expectations for 2024 Net Sales Percentage Growth in the Low Double Digits and 2024 Adjusted EBITDA Margin Above 20% MARIETTA, Ga., March 27, 2024 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today announced that the U.S. Food and Drug Administration (“FDA”) has issued a determination letter in connection with the RFD process related to AXIOFILL, a human-derived particulate wound dressing. In the letter, FDA reaffirmed its position that AXIOFILL does not meet the regulatory classification requirements of a Human Cell, Tissue or Cellular or Tissue-based Product (“HCT/P”) under Section 361 of the Public Health Service Act (“PHSA”). Joseph H. Capper, MIMEDX Chief Executive Officer, commented: “We are disappointed that the FDA, through the RFD process, has reached a conclusion that continues an inconsistent approach to regulating AXIOFILL and other human-d [Read more]
IMPACT SNAPSHOT
EVENT TIME:
MDXG
Last Price
Price Change
Price Change %
Volume Shares
Max Up
Max Down
Volume Ratio
%
Don't Miss Out On The Next BIG Stock Move
Performance comparison Updated
EVENT DAY
Stock performance from the time of news release until the following 4pm ET market close
LAST PRICE AT
NEWS EVENT
SINCE EVENT
Multi-day stock performance from the time of the news release
LAST PRICE
VWAP
High:
MAX UP
High:
Low:
MAX DOWN
Low:
%
 POST NEWS RANGE
%
PRICE CHANGE
PRICE CHANGE PERCENTAGE
S&P 500 (SPX)
%
 VOLUME RATIO
%
VOLUME (SHARES)
TICKS
AVG SHARES PER TRADE
EVENT DAY
Event Day Chart will not be displayed beyond 90-day period of the event
PERFORMANCE SINCE EVENT
TIME AND VELOCITY ANALYSIS