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Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Supplemental Biologics License Application

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
TARRYTOWN, N.Y., April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for the addition of extended dosing intervals (up to every 24 weeks) for EYLEA HD® (aflibercept) Injection 8 mg across all approved indications. The CRL did not identify any issues with the safety or efficacy of EYLEA HD in its approved indications and dosing regimens. The FDA did not agree with Regeneron’s proposal to add additional extended dosing intervals (greater than every 16 weeks, which is the maximum dosing interval currently indicated in the label). Regeneron is evaluating the FDA’s decision and will determine a path forward in due course. EYLEA HD is approved with dosing intervals from every 8 to 16 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), a [Read more]
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Stockreport

Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Supplemental Biologics License Application

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
TARRYTOWN, N.Y., April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for the addition of extended dosing intervals (up to every 24 weeks) for EYLEA HD® (aflibercept) Injection 8 mg across all approved indications. The CRL did not identify any issues with the safety or efficacy of EYLEA HD in its approved indications and dosing regimens. The FDA did not agree with Regeneron’s proposal to add additional extended dosing intervals (greater than every 16 weeks, which is the maximum dosing interval currently indicated in the label). Regeneron is evaluating the FDA’s decision and will determine a path forward in due course. EYLEA HD is approved with dosing intervals from every 8 to 16 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), a [Read more]
IMPACT SNAPSHOT
EVENT TIME:
REGN
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