Kiromic BioPharma’s Deltacel Receives FDA Fast Track Designation
KIROMIC BIOPHARMA INC (KRBP)
Company Research
Source: Business Wire
HOUSTON--(BUSINESS WIRE)--Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Deltacel™ (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy. The designation was awarded for KB-GDT-01 in combination with low-dose radiation therapy for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have progressed on at least two lines of standard of care therapy including platinum-based chemotherapy, immune checkpoint inhibitors and targeted therapy to improve progression-free survival and overall survival. Deltacel is currently being evaluated in the Deltacel-01 Phase 1 study in patients with stage 4 NSCLC who have failed to respond to standard therapies.Fast Track designation is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. T
Show less
Read more
Impact Snapshot
Event Time:
KRBP
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
KRBP 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
KRBP alerts
High impacting KIROMIC BIOPHARMA INC news events
Weekly update
A roundup of the hottest topics
KRBP
News
- Kiromic BioPharma Activates the University of Arizona Cancer Center as the Fifth Clinical Trial Site in the Ongoing Phase 1 Deltacel-01 TrialBusiness Wire
- Kiromic BioPharma Advances Deltacel-01 Into Expansion Phase Following Safety Monitoring Committee’s Unanimous RecommendationBusiness Wire
- Kiromic reports update from Phase I NSCLC treatment trial [Yahoo! Finance]Yahoo! Finance
- Kiromic BioPharma Provides Update on Part 1 of the Deltacel-01 Trial [Yahoo! Finance]Yahoo! Finance
- Kiromic BioPharma Provides Update on Part 1 of the Deltacel-01 TrialBusiness Wire
KRBP
Sec Filings
- 8/26/24 - Form 4
- 8/21/24 - Form 4
- 8/14/24 - Form 4
- KRBP's page on the SEC website