Sarepta Provides Regulatory Update on AMONDYS 45® and VYONDYS 53®
Sarepta Therapeutics, Inc. (SRPT)
Last sarepta therapeutics, inc. earnings: 2/26 04:05 pm
Check Earnings Report
US:NASDAQ Investor Relations:
investorrelations.sarepta.com/events-and-presentations
Company Research
Source: Business Wire
– Following feedback from FDA, Company intends to submit supplemental new drug applications to FDA by the end of April 2026 requesting conversion to traditional approval CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today provided an update on its ongoing regulatory interactions with the U.S. Food and Drug Administration (FDA) regarding AMONDYS 45® (casimersen) and VYONDYS 53® (golodirsen) for the treatment of Duchenne muscular dystrophy (DMD).Sarepta requested a meeting with FDA to discuss submitting supplemental new drug applications (sNDA) seeking conversion of the accelerated approvals of AMONDYS 45 and VYONDYS 53 to traditional approvals. This request was supported by data from the ESSENCE confirmatory study; substantial, published real-world evidence supporting treatment; and the favorable safety profiles of both therapies. Sarepta has received feedback from the Agency confirming that w
Show less
Read more
Impact Snapshot
Event Time:
SRPT
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
Be the first to know
Opt in for alerts from News Quantifed
Sign Up Today
Opt-in for
SRPT alerts
Learn More With NQ
Reading the Impact Report
Help Me Understand This Data
Help Me Understand This Data
How NQ Works
What is news-based trading?
And why is it so successful?
And why is it so successful?
Movers & Shakers
The biggest gainers and losers and WHY it moved
SRPT alerts
High impacting Sarepta Therapeutics, Inc. news events
Weekly update
A roundup of the hottest topics
SRPT
News
- Sarepta Therapeutics (SRPT) had its price target raised by Citigroup Inc. from $9.00 to $13.00. They now have a "sell" rating on the stock.MarketBeat
- Sarepta Therapeutics (SRPT) Soars 35.0%: Is Further Upside Left in the Stock? [Yahoo! Finance]Yahoo! Finance
- Sarepta Therapeutics (SRPT) had its "underperform" rating reaffirmed by Needham & Company LLC.MarketBeat
- Assessing Sarepta Therapeutics (SRPT) Valuation After Early siRNA Trial Results Spark Share Price Rebound [Yahoo! Finance]Yahoo! Finance
- Sarepta (SRPT) Skyrockets 35% on Morgan Stanley PT Hike, Stellar Trial Results [Yahoo! Finance]Yahoo! Finance
SRPT
Earnings
- 2/25/26 - Miss
SRPT
Sec Filings
- 3/27/26 - Form SCHEDULE
- 3/13/26 - Form 4
- 3/13/26 - Form 4
- SRPT's page on the SEC website