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UNCY Overview

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0.000(0.000%)Aft-market
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0.000
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Intellectia

Loading chart...

High
6.890
Open
6.800
VWAP
6.77
Vol
488.85K
Mkt Cap
146.36M
Low
6.610
Amount
3.31M
EV/EBITDA(TTM)
--
Total Shares
21.49M
EV
102.59M
EV/OCF(TTM)
--
P/S(TTM)
--
Unicycive Therapeutics, Inc. is a biotechnology company developing treatments for kidney diseases. The Company's lead drug candidate, oxylanthanum carbonate (OLC), is an investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Its second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury.
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Events Timeline

(ET)
2026-01-29
07:20:00
Unicycive Therapeutics OLC New Drug Application Accepted by FDA
select
2025-12-29 (ET)
2025-12-29
07:10:00
Unicycive Therapeutics Resubmits NDA to FDA for Oxylanthanum Carbonate
select
2025-11-12 (ET)
2025-11-12
07:17:21
Unicycive Therapeutics projects funding to last until 2027
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2025-11-12
07:17:04
Unicycive Therapeutics Announces Q3 EPS of 46c, Below Consensus Estimate of 53c
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2025-10-30 (ET)
2025-10-30
07:19:23
Unicycive Therapeutics to Showcase New OLC Findings at ASN Kidney Week 2025
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2025-10-28 (ET)
2025-10-28
07:09:19
Unicycive Offers Update on FDA Meeting and NDA Resubmission for OLC
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News

Globenewswire
7.0
03-18Globenewswire
ASP Isotopes Class Action Survives Dismissal Motion
  • Class Action Progress: The U.S. District Court for the Southern District of New York partially denied ASP Isotopes Inc. (NASDAQ: ASPI) and its executives' motion to dismiss, allowing the securities fraud class action to proceed, indicating significant legal exposure for the company.
  • False Statement Allegations: The lawsuit alleges that the company and its executives made materially false and misleading statements regarding their uranium enrichment technology prior to September 2024, raising approximately $18.6 million without actual testing, which could have long-term financial repercussions for the firm.
  • Investor Rights Protection: Investors who purchased ASP Isotopes securities before September 26, 2024, can seek corporate reforms and fund recovery, suggesting that legal proceedings may provide remedies for affected investors and enhance market confidence in corporate governance.
  • Future Risk Assessment: As the lawsuit progresses, ASP Isotopes may face increased regulatory scrutiny and a crisis of market trust, impacting its future financing capabilities and business development strategies, necessitating close monitoring of subsequent developments.
Globenewswire
7.0
03-16Globenewswire
ASP Isotopes Class Action Survives Dismissal Motion
  • Class Action Progress: The class action against ASP Isotopes (NASDAQ: ASPI) continues after the Southern District of New York partially denied the defendants' motion to dismiss, indicating potential legal liabilities for the company and its executives, which could undermine investor confidence.
  • False Statement Allegations: The lawsuit alleges that the company made materially false and misleading statements regarding its uranium enrichment technology prior to September 2024, raising approximately $18.6 million without actual testing, which may have long-term implications for its financial health.
  • Investor Rights Protection: Investors who purchased ASP Isotopes securities before September 26, 2024, can seek corporate reforms and fund recovery, highlighting the potential impact of legal actions on corporate governance structures.
  • Market Reaction: As the lawsuit progresses, investor confidence in the company's future may wane, leading to stock price volatility, reflecting the market's heightened scrutiny of the company's transparency and compliance.
Newsfilter
8.5
01-29Newsfilter
Unicycive's Drug Application Accepted by FDA with Target Date Set
  • FDA Acceptance: Unicycive's New Drug Application for oxylanthanum carbonate (OLC) has been accepted by the FDA, with a Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026, marking a significant advancement in chronic kidney disease treatment.
  • Strong Financial Position: Unicycive ended 2025 with an unaudited cash position of $41.3 million, which is expected to support its OLC commercialization activities into 2027, ensuring ongoing investment in research and market launch efforts.
  • Clinical Research Support: The NDA for OLC is backed by data from three clinical studies, demonstrating its potential in treating hyperphosphatemia, and the FDA raised no concerns regarding its safety or efficacy data, bolstering market confidence.
  • Strong Market Demand: Hyperphosphatemia is prevalent among end-stage renal disease patients, with over 450,000 individuals annually requiring medication to control phosphate levels, and the launch of OLC will provide a crucial treatment option for this large patient population, indicating significant market potential.
seekingalpha
9.0
01-29seekingalpha
Unicycive's Kidney Disease Therapy NDA Accepted by FDA
  • Drug Application Progress: Unicycive Therapeutics announced that the FDA has accepted its New Drug Application for oxylanthanum carbonate, marking a significant advancement in treating hyperphosphatemia in chronic kidney disease patients.
  • FDA Review Timeline: The FDA has set a target action date of June 27, 2026, indicating that the resubmission is classified as a Class II complete response, which entails a six-month review period.
  • Financial Position: As of the end of 2025, Unicycive reported $41.3 million in cash and short-term investments, demonstrating the company's capacity to support future drug launch activities.
  • Market Outlook: The company noted that its current liquidity position could facilitate potential launch activities for OLC and extend its cash runway into 2027, enhancing its competitive stance in the market.
Newsfilter
8.5
01-29Newsfilter
Unicycive's Drug Application Accepted by FDA
  • Drug Application Progress: Unicycive's oxylanthanum carbonate (OLC) New Drug Application has been accepted by the FDA, with a review period ending on June 27, 2026, laying the groundwork for the company's market launch among chronic kidney disease patients.
  • Strong Financial Position: Unicycive ended 2025 with $41.3 million in cash and short-term investments, ensuring continued advancement of OLC's commercialization activities into 2027, thereby enhancing its competitive edge in the market.
  • Clinical Research Support: The NDA for OLC is backed by data from three clinical studies and multiple preclinical studies, with the FDA raising no concerns regarding its safety or efficacy, providing robust support for the drug's approval.
  • Significant Market Potential: As a novel oral phosphate binder, OLC is expected to significantly improve treatment adherence among chronic kidney disease patients, addressing the urgent needs of over 450,000 individuals in the U.S. requiring medication to control phosphate levels annually.
NASDAQ.COM
9.0
2025-12-29NASDAQ.COM
Unicycive Resubmits NDA for OLC to Treat Hyperphosphatemia in CKD Patients
  • NDA Resubmission: Unicycive Therapeutics has resubmitted its New Drug Application for oxylanthanum carbonate (OLC) to the FDA, aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis, marking a significant step in addressing previously cited deficiencies.
  • Compliance Progress: The resubmission follows substantial progress by the company's original third-party manufacturing vendor in rectifying issues identified by the FDA, demonstrating the company's commitment to regulatory compliance.
  • Financial Stability: CEO Shalabh Gupta noted that with a cash runway extending into 2027, the company is well-positioned to complete the regulatory process and prepare for a potential OLC launch, which enhances market confidence.
  • Stock Price Increase: Following the resubmission announcement, Unicycive's shares closed at $6.07 on Friday, reflecting a 3.58% increase, indicating investor optimism regarding the company's future prospects.
Wall Street analysts forecast UNCY stock price to rise
5 Analyst Rating
Wall Street analysts forecast UNCY stock price to rise
5 Buy
0 Hold
0 Sell
Strong Buy
Current: 0.000
sliders
Low
21.00
Averages
35.80
High
60.00
Current: 0.000
sliders
Low
21.00
Averages
35.80
High
60.00
WestPark Capital
Buy
initiated
$72
AI Analysis
2026-02-19
Reason
WestPark Capital
Price Target
$72
AI Analysis
2026-02-19
initiated
Buy
Reason
WestPark Capital initiated coverage of Unicycive Therapeutics with a Buy rating and $72 price target. Given the view that a significant number of dialysis organizations are likely to switch to OLC next year, the firm calls Unicycive "a compelling investment" with a fully de-risked PDUFA on June 29, market launch of "a best-in-class drug" in Q3 of 2026, and TDAPA reimbursement support likely beginning on January 1, 2027. The firm anticipates "significant" stock appreciation ahead of likely approval, the analyst added.
H.C. Wainwright
H.C. Wainwright
NULL -> Buy
maintain
$9 -> $22
2025-10-29
Reason
H.C. Wainwright
H.C. Wainwright
Price Target
$9 -> $22
2025-10-29
maintain
NULL -> Buy
Reason
H.C. Wainwright raised the firm's price target on Unicycive Therapeutics to $22 from $9 and keeps a Buy rating on the shares. The believes the company's regulatory overhang has been revolved after its Type A meeting with the FDA. Unicycive plans to file a response to the complete response letter by year-end and expects a decision in the first half of 2026, the analyst tells investors in a research note.
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Valuation Metrics

The current forward P/E ratio for Unicycive Therapeutics Inc (UNCY.O) is 1.59, compared to its 5-year average forward P/E of -0.46. For a more detailed relative valuation and DCF analysis to assess Unicycive Therapeutics Inc's fair value, Click here.

Forward PE

The forward P/E ratio is a valuation metric that divides a company's current stock price by its estimated future earnings per share over the next 12 months.
StronglyUndervaluedUndervaluedFairOvervaluedStronglyOvervalueddotted line Image
N/A
5Y Average PE
-0.46
Current PE
1.59
Overvalued PE
6.55
Undervalued PE
-7.47

Forward EV/EBITDA

The forward EV/EBITDA ratio is a valuation metric that divides a company's enterprise value (EV) by its estimated future earnings before interest, taxes, depreciation, and amortization (EBITDA) over the next 12 months.
StronglyUndervaluedUndervaluedFairOvervaluedStronglyOvervalueddotted line Image
N/A
5Y Average EV/EBITDA
-6055.47
Current EV/EBITDA
0.00
Overvalued EV/EBITDA
22432.39
Undervalued EV/EBITDA
-34543.34

Forward PS

The forward P/S ratio is a valuation metric that divides a company's current stock price by its estimated future sales (or revenue) per share over the next 12 months.
StronglyUndervaluedUndervaluedFairOvervaluedStronglyOvervalueddotted line Image
N/A
5Y Average PS
4.42
Current PS
1.12
Overvalued PS
16.53
Undervalued PS
-7.69

Financials

AI Analysis
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Quarterly

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Whales Holding UNCY

V
Vivo Capital, LLC
Holding
UNCY
+7.34%
3M Return

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Frequently Asked Questions

What is Unicycive Therapeutics Inc (UNCY) stock price today?

The current price of UNCY is 6.81 USD — it has increased 0.74

What is Unicycive Therapeutics Inc (UNCY)'s business?

Unicycive Therapeutics, Inc. is a biotechnology company developing treatments for kidney diseases. The Company's lead drug candidate, oxylanthanum carbonate (OLC), is an investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Its second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury.

What is the price predicton of UNCY Stock?

Wall Street analysts forecast UNCY stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for UNCY is35.80 USD with a low forecast of 21.00 USD and a high forecast of 60.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.

What is Unicycive Therapeutics Inc (UNCY)'s revenue for the last quarter?

Unicycive Therapeutics Inc revenue for the last quarter amounts to 0.00 USD, decreased

What is Unicycive Therapeutics Inc (UNCY)'s earnings per share (EPS) for the last quarter?

Unicycive Therapeutics Inc. EPS for the last quarter amounts to -0.33 USD, decreased -28.26

How many employees does Unicycive Therapeutics Inc (UNCY). have?

Unicycive Therapeutics Inc (UNCY) has 22 emplpoyees as of March 20 2026.

What is Unicycive Therapeutics Inc (UNCY) market cap?

Today UNCY has the market capitalization of 146.36M USD.