Your email has been successfully added to our mailing list.

×
0 -0.0127758420441349 -0.0272938443670152 -0.039198606271777 -0.0178193960511034 -0.0095818815331012 -0.01335656213705 0.00362950058072009
Stock impact report

Agios Advances Mitapivat Toward Potential U.S. Accelerated Approval in Sickle Cell Disease Following Pre-sNDA Meeting with FDA [Yahoo! Finance]

Agios Pharmaceuticals, Inc. (AGIO) 
Last agios pharmaceuticals, inc. earnings: 4/30 07:00 am Check Earnings Report
US:NASDAQ Investor Relations: investor.agios.com/investor-overview
Company Research Source: Yahoo! Finance
Company has already submitted proposed confirmatory trial for FDA review, as required under accelerated approval pathway Company plans to submit mitapivat sNDA in sickle cell disease in the coming months, and is actively working with FDA to achieve alignment on confirmatory trial required for submission CAMBRIDGE, Mass., March 31, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that it will pursue U.S. accelerated approval for mitapivat, an oral pyruvate kinase (PK) activator, in sickle cell disease, following completion of its pre-supplemental New Drug Application (sNDA) meeting with the U.S. Food and Drug Administration (FDA). The purpose of the pre-sNDA meeting was to present the data from the mitapivat RISE UP clinical program in sickle cell disease, including both the Phase 2 and Phase 3 trials. Based on the discussio Show less Read more
Impact Snapshot
Event Time:
AGIO
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 AGIO alerts
Opt-in for
AGIO alerts

from News Quantified
Opt-in for
AGIO alerts

from News Quantified