Your email has been successfully added to our mailing list.

×
-0.00526315789473685 -0.0105263157894737 -0.0368421052631579 -0.0421052631578948 -0.0526315789473685 -0.0473684210526316 -0.0421052631578948 -0.0421052631578948
Stock impact report

FDA Determines that Afrezza REMS Communication Plan Has Met Goals and REMS No Longer Necessary

MannKind Corporation (MNKD) 
Last mannkind corporation earnings: 2/25 08:00 am Check Earnings Report
US:NASDAQ Investor Relations: investors.mannkindcorp.com/press-releases
Company Research Source: GlobeNewswire
WESTLAKE VILLAGE, Calif., April 25, 2018 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD), focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, today announced that the Food and Drug Administration (FDA) has completed its review of a supplemental New Drug Application (sNDA) for Afrezza (insulin human) inhalation powder and has determined that the Risk Evaluation and Mitigation Strategy (REMS) communication plan regarding the risks of Afrezza has been completed and has met its goals. As a result, the FDA has decided that a REMS is no longer required for Afrezza. “We are pleased that the FDA determined that a communication plan is no longer necessary to ensure the benefits of Afrezza outweigh its risks and that a REMS is no longer required,” stated Dr. David Kendall, Chief Medical Officer of MannKind. “We are grateful for the FDA’s guidance and expediency in this process Show less Read more
Impact Snapshot
Event Time:
MNKD
Last Price
Price Change
Price Change%
Volume Shares
Max Up
Max Down
%
Volume Ratio
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
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
Ticks

Avg transaction size

Don't Miss Out On The Next BIG Stock Move
Event day
Event Day Chart will not be displayed beyond 90-day period of the event
Performance since event
Time And Velocity Analysis
Opt-in for MNKD alerts
Opt-in for
MNKD alerts

from News Quantified
Opt-in for
MNKD alerts

from News Quantified