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UNCY Overview

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$
0.000
0.000(0.000%)
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0.000(0.000%)Aft-market
ET
$
0.000
0.000(0.000%)
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0.000(0.000%)Aft-market
ET
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Intellectia

Loading chart...

High
4.850
Open
4.570
VWAP
4.65
Vol
1.56M
Mkt Cap
224.90M
Low
4.450
Amount
7.26M
EV/EBITDA(TTM)
--
Total Shares
27.39M
EV
151.00M
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)
2026-06-30
09:00:00
Markets End Cautiously, Semiconductor Stocks Drive Gains
select
2026-06-30
07:30:00
Unicycive Receives Complete Response Letter from FDA
select
2026-06-26 (ET)
2026-06-26
13:00:00
Unicycive Resubmits Drug Application, Price Target $22
select
2026-06-05 (ET)
2026-06-05
16:20:00
Unicycive Therapeutics Files $150M Mixed Securities Shelf
select

News

stocktwits
9.0
06-30stocktwits
PinnedUnicycive's Drug Faces Second FDA Rejection
  • FDA Rejection: Unicycive's drug oxylanthanum carbonate (OLC) faced a second rejection from the FDA due to third-party manufacturing deficiencies rather than clinical safety or efficacy issues, resulting in a 39% drop in stock price in a single day.
  • Analysts Maintain Ratings: Despite the FDA's rejection, both B. Riley and H.C. Wainwright maintained their 'Buy' ratings on UNCY, with B. Riley setting a price target of $22 and H.C. Wainwright lowering it to $15, reflecting confidence in the company's long-term commercial prospects.
  • Active FDA Engagement: Unicycive stated it is in active discussions with the FDA, optimistic about a successful inspection of the third-party manufacturer and plans to expeditiously resubmit the New Drug Application (NDA), indicating continued confidence in the drug's efficacy and safety.
  • Retail Sentiment Optimistic: Despite the stock's decline, retail investor sentiment on Stocktwits remains in the 'extremely bullish' territory, with some users expressing optimism about eventual drug approval, highlighting market expectations for the company's future.
Newsfilter
8.5
06-30Newsfilter
PinnedUnicycive Receives Complete Response Letter from FDA
  • FDA Response Letter: Unicycive Therapeutics received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for oxylanthanum carbonate, indicating that the FDA did not raise concerns about clinical efficacy or safety data, and no additional data was requested, reflecting recognition of the product's potential.
  • Inspection Delays: The FDA has not yet conducted an inspection of the third-party manufacturer, which aligns with deficiencies noted in the previous CRL issued in June 2025, indicating ongoing challenges for Unicycive in resolving these issues that could impact the NDA approval timeline.
  • Clinical Research Support: The NDA for OLC is supported by data from three clinical studies, including a Phase 1 study in healthy volunteers and a tolerability study in CKD patients, demonstrating its potential in treating hyperphosphatemia and possibly improving patient adherence to treatment.
  • Future Outlook: Unicycive's CEO expressed confidence in the efficacy and safety of OLC and is actively discussing labeling and packaging with the FDA, anticipating a successful inspection of the third-party manufacturer and a swift resubmission of the NDA, showcasing the company's optimistic outlook for the future.
Globenewswire
7.0
14:47 PMGlobenewswire
Block & Leviton Investigates Unicycive Therapeutics for Securities Violations
  • Investigation Background: Block & Leviton is investigating Unicycive Therapeutics for potential securities law violations, specifically whether the company made false or misleading statements to investors or failed to disclose material information regarding the FDA's review of its OLC New Drug Application.
  • FDA Response: On June 30, 2026, Unicycive announced that the FDA issued a second Complete Response Letter for its resubmitted OLC NDA, citing the same third-party manufacturing deficiencies identified in a prior Complete Response Letter from June 2025, which led to a decline in the company's stock price.
  • Investor Rights: Any investor who purchased Unicycive stock and experienced losses is encouraged to contact Block & Leviton to learn how they might recover those losses, demonstrating the firm's commitment to protecting investor interests.
  • Whistleblower Program: Block & Leviton invites whistleblowers with non-public information to assist in the investigation, stating that those who provide original information to the SEC may receive rewards of up to 30% of any successful recovery, thereby enhancing the appeal for investor cooperation.
seekingalpha
9.0
06-30seekingalpha
Unicycive Therapeutics Shares Plunge 37% After FDA Response
  • FDA Complete Response Letter: Unicycive Therapeutics announced it received a Complete Response Letter from the FDA regarding its resubmitted NDA, resulting in a ~37% drop in stock price during Tuesday afternoon trading, indicating significant setbacks in the drug development for treating hyperphosphatemia in chronic kidney disease patients.
  • Manufacturing Issues Impact: This response letter is linked to another Complete Response Letter received in June 2025 concerning manufacturing issues at a third-party site, highlighting ongoing challenges in production compliance that could affect the company's competitive position in the market.
  • Reinspection Failure: The FDA was unable to re-inspect the manufacturing site by the action date of June 26, indicating a lack of confidence from regulators in the facility, which may lead to further delays and uncertainties impacting the company's future product launch plans.
  • Intensifying Market Competition: Unicycive CEO Shalabh Gupta mentioned in a recent interview that despite these challenges, OLC aims to distinguish itself in the crowded hyperphosphatemia market, reflecting the company's optimistic outlook on its product's market potential despite current regulatory hurdles.
Globenewswire
7.0
06-30Globenewswire
Unicycive Therapeutics Under Investigation Following FDA Response, Stock Declines
  • FDA Response Impact: On June 30, 2026, Unicycive Therapeutics announced that the FDA issued a second Complete Response Letter regarding its resubmitted OLC NDA, indicating unresolved third-party manufacturing deficiencies, which led to a decline in stock price and investor confidence.
  • Investigation Initiated: Johnson Fistel, PLLP is investigating whether Unicycive made false or misleading statements or failed to disclose material information related to the FDA review process, potentially affecting the recoverability of investor losses.
  • Investor Losses: Investors who suffered losses after purchasing Unicycive securities are encouraged to contact Johnson Fistel for more information about the investigation, highlighting the firm's commitment to protecting investor rights and possibly leading to further legal actions.
  • Ongoing Regulatory Scrutiny: Unicycive disclosed that the FDA has not yet inspected its third-party manufacturer, and this revelation may exacerbate market concerns regarding the company's future compliance, impacting its long-term strategic development.
stocktwits
9.0
06-30stocktwits
Unicycive Faces Second FDA Rejection for Kidney Drug
  • Regulatory Setback: Unicycive Therapeutics received a Complete Response Letter (CRL) from the FDA for its kidney drug candidate Oxylanthanum Carbonate, indicating that the drug cannot be approved in its current form, which led to a more than 45% drop in share price on Tuesday.
  • Manufacturing Deficiencies: The CRL is linked to previously identified deficiencies at a third-party manufacturing facility rather than concerns about the drug's safety or efficacy, highlighting the complexities of the regulatory process despite no FDA concerns regarding clinical data.
  • Financial Stability: Unicycive reported having $57.1 million in cash and equivalents, expected to fund operations into 2027, although the new CRL could alter the company's outlook and introduce additional uncertainties.
  • Market Sentiment Fluctuations: Despite the significant stock decline, retail sentiment on Stocktwits remains in the 'extremely bullish' territory with message volumes surging over 380%, although some users predict a further 25% drop in stock price, indicating market concerns about future performance.
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
Noble Capital
Outperform
maintain
$60 -> $50
AI Analysis
2026-07-01
New
Reason
Noble Capital
Price Target
$60 -> $50
AI Analysis
2026-07-01
New
maintain
Outperform
Reason
Noble Capital lowered the firm's price target on Unicycive Therapeutics to $50 from $60 and keeps an Outperform rating on the shares after the company announced it has received a Complete Response Letter from the FDA stating that the NDA for oxylanthanum carbonate has not been approved due to a required inspection of the third-party manufacturing vendor. The firm now expects product approval around year-end 2026, the analyst tells investors.
Benchmark
Benchmark
Speculative Buy
downgrade
$18 -> $13
2026-07-01
New
Reason
Benchmark
Benchmark
Price Target
$18 -> $13
2026-07-01
New
downgrade
Speculative Buy
Reason
Benchmark lowered the firm's price target on Unicycive Therapeutics to $13 from $18 and keeps a Speculative Buy rating on the shares after the company received a new Complete Response Letter from the FDA regarding the New Drug Application for oxylanthanum carbonate, once again related to a deficiency at a third-party manufacturing vendor. The firm is shifting its model forward, noting that the company "remains optimistic" about an inspection of the third-party manufacturing vendor in the next few weeks, after which it will "expeditiously" resubmit the NDA.
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Valuation Metrics

The current forward P/E ratio for Unicycive Therapeutics Inc (UNCY.O) is 3.44, compared to its 5-year average forward P/E of -0.10. 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
-0.10
Current PE
3.44
Overvalued PE
6.65
Undervalued PE
-6.85

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
-6060.87
Current EV/EBITDA
0.00
Overvalued EV/EBITDA
22439.11
Undervalued EV/EBITDA
-34560.85

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
4.03
Current PS
0.56
Overvalued PS
15.58
Undervalued PS
-7.53

Financials

AI Analysis
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Quarterly

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Whales Holding UNCY

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Holding
UNCY
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Frequently Asked Questions

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

The current price of UNCY is 4.65 USD — it has decreased -0.85

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 -0.54 USD, decreased -1450.00

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

Unicycive Therapeutics Inc (UNCY) has 21 emplpoyees as of July 01 2026.

What is Unicycive Therapeutics Inc (UNCY) market cap?

Today UNCY has the market capitalization of 224.90M USD.