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Dupixent® (dupilumab) sBLA Accepted for FDA Review for the Treatment of Chronic Spontaneous Urticaria (CSU)

Regeneron Pharmaceuticals, Inc. (REGN)  More Company Research Source: GlobeNewswire
Last regeneron pharmaceuticals, inc. earnings: 2/6 06:30 am Check Earnings Report
US:NASDAQ Investor Relations: investor.regeneron.com
Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines FDA decision expected by April 18, 2025; if approved, Dupixent would be the first targeted therapy for CSU in a decade TARRYTOWN, N.Y. and PARIS, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. The target action date for the FDA decision is April 18, 2025.   The resubmitted sBLA is supported by data from the multi-trial, LIBERTY-CUPID Phase 3 clinical program (Study A [Read more]
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Stockreport

Dupixent® (dupilumab) sBLA Accepted for FDA Review for the Treatment of Chronic Spontaneous Urticaria (CSU)

Regeneron Pharmaceuticals, Inc.  (REGN) 
More Company Research Source: GlobeNewswire
Last regeneron pharmaceuticals, inc. earnings: 2/6 06:30 am Check Earnings Report
US:NASDAQ Investor Relations: investor.regeneron.com
Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines FDA decision expected by April 18, 2025; if approved, Dupixent would be the first targeted therapy for CSU in a decade TARRYTOWN, N.Y. and PARIS, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. The target action date for the FDA decision is April 18, 2025.   The resubmitted sBLA is supported by data from the multi-trial, LIBERTY-CUPID Phase 3 clinical program (Study A [Read more]
IMPACT SNAPSHOT
EVENT TIME:
REGN
Last Price
Price Change
Price Change %
Volume Shares
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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
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MAX UP
High:
Low:
MAX DOWN
Low:
%
 POST NEWS RANGE
%
PRICE CHANGE
PRICE CHANGE PERCENTAGE
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%
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%
VOLUME (SHARES)
TICKS
AVG SHARES PER TRADE
EVENT DAY
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PERFORMANCE SINCE EVENT
TIME AND VELOCITY ANALYSIS