Scholar Rock Resubmits Apitegromab BLA for SMA, Adds Second Fill-Finish Site; FDA Decision Eyed by Sept. [Yahoo! Finance]
Scholar Rock Holding Corporation (SRRK)
Last scholar rock holding corporation earnings: 11/12 07:30 am
Check Earnings Report
Company Research
Source: Yahoo! Finance
Indiana inspection by adding a second U.S. fill-finish site, with FDA acceptance expected within 30 days and a potential regulatory decision by late September (up to a six-month review). The two-site approach provides “significant optionality”: the FDA will reinspect Catalent (a Form 483 is possible) while the second facility gives an alternate path so whichever site enables the fastest approval can remain in the BLA. Management says it is commercially ready with sufficient supply (including from the second site alone), ongoing payer engagement and limited incremental cash burn, and expects a priority review voucher on approval; European MAA review is on track for mid-2026 but depends on FDA clearance of the Catalent site. Interested in Scholar Rock Holding Corporation? Here are five stocks we like better. 3 Beaten-Down Stocks With Rebound Potential This Earnings Season Scholar Rock (NASDAQ:SRRK) said it has resubmitted its Biologics License Application (BLA) to the U.S. Foo
Show less
Read more
Impact Snapshot
Event Time:
SRRK
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
SRRK 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
SRRK alerts
High impacting Scholar Rock Holding Corporation news events
Weekly update
A roundup of the hottest topics
SRRK
News
- Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business Wire
- Scholar Rock to Report First Quarter 2026 Financial Results on May 7, 2026Business Wire
- Scholar Rock (SRRK) Deepens SMA Manufacturing Footprint: Strategic Resilience Move or Regulatory Risk Signal? [Yahoo! Finance]Yahoo! Finance
- Scholar Rock (SRRK) had its price target raised by Wedbush from $56.00 to $58.00. They now have an "outperform" rating on the stock.MarketBeat
- Scholar Rock Holding Corporation (SRRK) Discusses BLA Resubmission for Apitegromab in Spinal Muscular Atrophy and Regulatory Progress Transcript [Seeking Alpha]Seeking Alpha
SRRK
Earnings
- 3/3/26 - Miss
SRRK
Sec Filings
- 4/6/26 - Form 144
- 3/31/26 - Form 8-K
- 3/27/26 - Form SCHEDULE
- SRRK's page on the SEC website