Celularity Submits Request to U.S. FDA for Orphan Drug Designation for PDA-002 Asset Treating Facioscapulohumeral Muscular Dystrophy [Yahoo! Finance]
Celularity Inc. - Class A (CELU)
Company Research
Source: Yahoo! Finance
FLORHAM PARK, N.J., March 20, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (NASDAQ: CELU) (“Celularity”), a regenerative medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, announced today that it has submitted a request to the U.S. Food and Drug Administration (FDA) for orphan drug designation for its off-the-shelf, placental-derived cell therapy, PDA-002, for treating Facioscapulohumeral Muscular Dystrophy (FSHD). Orphan drug designation is a status given to drugs that show the potential to treat, prevent or diagnose serious or life-threatening diseases that affect fewer than people in the U.S. Earlier, Celularity received FDA Investigational New Drug Application clearance for PDA-002 in FSHD and plans to commence a phase 1/2 study in the second half of 2024. The trial serves as an important component for submitting a Biologics License Application (BLA) to the FDA in the future as a potential treatment for FSHD and other types of
Show less
Read more
Impact Snapshot
Event Time:
CELU
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
CELU 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
CELU alerts
High impacting Celularity Inc. - Class A news events
Weekly update
A roundup of the hottest topics
CELU
News
- Celularity Inc. to Host Investor and Analyst Research & Development Day [Yahoo! Finance]Yahoo! Finance
- Celularity Inc. to Host Investor and Analyst Research & Development DayGlobeNewswire
- Celularity Inc. Announces Receipt of Nasdaq Notice Regarding Late Form 10-K Filing [Yahoo! Finance]Yahoo! Finance
- Celularity Inc. Announces Receipt of Nasdaq Notice Regarding Late Form 10-K FilingGlobeNewswire
- Celularity Abstract “Emerging Technologies for the Management and Protection of Tendon Injuries: Decellularized Placental Biomaterials” Accepted at ORS Tendon Conference 2024 [Yahoo! Finance]Yahoo! Finance
CELU
Earnings
- 1/2/24 - Miss
CELU
Sec Filings
- 4/22/24 - Form 8-K
- 4/16/24 - Form 4
- 4/16/24 - Form 4
- CELU's page on the SEC website