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Stockreport

FDA Approves New High Dose Regimen of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy

Biogen Inc. (BIIB)  More Company Research Source: GlobeNewswire
Last biogen inc. earnings: 4/22 07:12 am Check Earnings Report
US:NASDAQ Investor Relations: biogen.com/en_us/investors.html
The approval was anchored on data from the pivotal DEVOTE study that investigated the efficacy and safety of the High Dose Regimen of SPINRAZA in treatment-naïve and previously treated SPINRAZA patientsHigh Dose SPINRAZA will be available in the United States in the coming weeks and is also approved in the European Union, Switzerland and Japan CAMBRIDGE, Mass., March 30, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the High Dose Regimen of SPINRAZA® (nusinersen), which is comprised of 50 mg/5 mL and 28 mg/5 mL doses, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of spinal muscular atrophy (SMA). Backed by more than 10 years of clinical data supporting the Low Dose Regimen of SPINRAZA (12 mg), High Dose SPINRAZA was designed to deliver a higher concentration of drug through both the loading and maintenance dosing phases, to provide a new option in response to the ongoing needs of the community. The High Dose Regimen of SPI [Read more]
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Stockreport

FDA Approves New High Dose Regimen of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy

Biogen Inc.  (BIIB) 
More Company Research Source: GlobeNewswire
Last biogen inc. earnings: 4/22 07:12 am Check Earnings Report
US:NASDAQ Investor Relations: biogen.com/en_us/investors.html
The approval was anchored on data from the pivotal DEVOTE study that investigated the efficacy and safety of the High Dose Regimen of SPINRAZA in treatment-naïve and previously treated SPINRAZA patientsHigh Dose SPINRAZA will be available in the United States in the coming weeks and is also approved in the European Union, Switzerland and Japan CAMBRIDGE, Mass., March 30, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the High Dose Regimen of SPINRAZA® (nusinersen), which is comprised of 50 mg/5 mL and 28 mg/5 mL doses, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of spinal muscular atrophy (SMA). Backed by more than 10 years of clinical data supporting the Low Dose Regimen of SPINRAZA (12 mg), High Dose SPINRAZA was designed to deliver a higher concentration of drug through both the loading and maintenance dosing phases, to provide a new option in response to the ongoing needs of the community. The High Dose Regimen of SPI [Read more]
IMPACT SNAPSHOT
EVENT TIME:
BIIB
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
High:
MAX UP
High:
Low:
MAX DOWN
Low:
%
 POST NEWS RANGE
%
PRICE CHANGE
PRICE CHANGE PERCENTAGE
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%
 VOLUME RATIO
%
VOLUME (SHARES)
TICKS
AVG SHARES PER TRADE
EVENT DAY
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PERFORMANCE SINCE EVENT
TIME AND VELOCITY ANALYSIS