Unicycive Therapeutics Announces U.S. FDA Acceptance of the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidn...
Unicycive Therapeutics, Inc. (UNCY)
Company Research
Source: GlobeNewswire
– FDA sets PDUFA Action Date of June 28, 2025 – Company Preparing for 2025 Commercial Launch – LOS ALTOS, Calif., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) and has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025. If approved, OLC has the potential to meaningfully improve the treatment burden for hyperphosphatemia patients with chronic kidney disease (CKD) on dialysis. “We are thrilled with the FDA acceptance of our first NDA, a significant milestone towards our efforts to bring this important treatment option to patients with kidney disease if approved,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “CKD patients on dialysis with hyp
Show less
Read more
Impact Snapshot
Event Time:
UNCY
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
UNCY 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
UNCY alerts
High impacting Unicycive Therapeutics, Inc. news events
Weekly update
A roundup of the hottest topics
UNCY
News
- Unicycive Therapeutics Announces Publication of Oxylanthanum Carbonate (OLC) Positive Bioequivalence Data in Clinical Therapeutics [Yahoo! Finance]Yahoo! Finance
- Unicycive Therapeutics Announces Publication of Oxylanthanum Carbonate (OLC) Positive Bioequivalence Data in Clinical TherapeuticsGlobeNewswire
- Breakeven On The Horizon For Unicycive Therapeutics, Inc. (NASDAQ:UNCY) [Yahoo! Finance]Yahoo! Finance
- Unicycive Therapeutics, Inc. (NASDAQ: UNCY) had its "speculative buy" rating re-affirmed by analysts at Benchmark Co.. They now have a $3.00 price target on the stock.MarketBeat
- Unicycive Therapeutics to Participate in Two Upcoming Investor Conferences Including a Fireside Chat at the Piper Sandler 36th Annual Healthcare ConferenceGlobeNewswire
UNCY
Sec Filings
- 12/20/24 - Form SCHEDULE
- 12/20/24 - Form SCHEDULE
- 11/21/24 - Form EFFECT
- UNCY's page on the SEC website