Celcuity CEO Details Gedatolisib NDA, July PDUFA and Launch Plans at TD Cowen Conference [Yahoo! Finance]
Celcuity Inc. (CELC)
Last celcuity inc. earnings: 3/12 04:00 pm
Check Earnings Report
US:NASDAQ Investor Relations:
celcuity.com/home/investors
Company Research
Source: Yahoo! Finance
plus Breakthrough Therapy designations, and management expects an approval decision around the PDUFA date while planning a potential supplemental NDA for mutant-cohort data to seek expedited review again. The company has been building commercial infrastructure for roughly two years, expects to onboard sales reps in Q2, and will initially target patients with PIK3CA wild-type disease (˜60% of patients), estimating ~37,000 second-line eligible patients and a potential $10 billion peak breast-cancer opportunity if expanded to first-line use. Phase 3 and additional cohort readouts are imminent with a mutant-cohort statistical success benchmark of about a 10-month median PFS , and gedatolisib shows a favorable tolerability profile with less than 10% overall hyperglycemia (2% Grade 3) versus ~80% for alpelisib, though stomatitis is higher but reportedly manageable. Interested in Celcuity, Inc.? Here are five stocks we like better. 3 Stocks You'll Wish You Bought Before 2026 Celcui
Show less
Read more
Impact Snapshot
Event Time:
CELC
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
CELC 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
CELC alerts
High impacting Celcuity Inc. news events
Weekly update
A roundup of the hottest topics
CELC
News
- Celcuity (CELC) had its price target raised by Stifel Nicolaus from $115.00 to $125.00. They now have a "buy" rating on the stock.MarketBeat
- Celcuity (CELC) had its "buy" rating reaffirmed by Needham & Company LLC. They now have a $122.00 price target on the stock.MarketBeat
- Celcuity Inc (CELC) Q4 2025 Earnings Call Highlights: Navigating Losses Amidst Promising Drug ... [Yahoo! Finance]Yahoo! Finance
- Celcuity Inc. (CELC) Q4 2025 Earnings Call Transcript [Seeking Alpha]Seeking Alpha
- Celcuity outlines potential $2.5B annual peak revenue for gedatolisib amid pivotal clinical milestones and commercial launch preparations [Seeking Alpha]Seeking Alpha
CELC
Earnings
- 3/25/26 - Beat
CELC
Sec Filings
- 3/26/26 - Form 10-K
- 3/25/26 - Form 8-K
- 3/24/26 - Form SCHEDULE
- CELC's page on the SEC website