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UNCY Overview

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

Loading chart...

High
5.440
Open
5.360
VWAP
5.29
Vol
2.35M
Mkt Cap
148.74M
Low
5.010
Amount
12.41M
EV/EBITDA(TTM)
--
Total Shares
27.39M
EV
88.53M
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
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News

Globenewswire
7.0
07-07Globenewswire
Unicycive Under Investigation for Securities Violations
  • FDA Response Letter: On June 30, 2026, Unicycive announced that the FDA issued a second Complete Response Letter (CRL) regarding its resubmitted New Drug Application for kidney disease therapy, indicating the same third-party manufacturing deficiencies identified in the prior June 2025 CRL, highlighting significant hurdles in the drug approval process.
  • Stock Price Plunge: Following this announcement, Unicycive's stock price fell from $7.70 per share on June 29, 2026, to $4.69 on June 30, representing a 39% decline, reflecting strong investor concerns about the company's future prospects.
  • Legal Investigation Initiated: Kirby McInerney LLP reminds investors of its ongoing investigation into potential violations of federal securities laws by Unicycive and its senior management, with no lawsuits filed yet, indicating possible reputational and shareholder equity impacts for the company.
  • Investor Rights Protection: The law firm encourages investors who purchased or acquired Unicycive securities to contact them to discuss their rights, emphasizing that protecting investor interests will be a focal point as the company faces legal challenges.
Globenewswire
7.0
07-02Globenewswire
Unicycive Faces Investor Lawsuit Investigation
  • FDA Response Letter: On June 30, 2026, Unicycive announced that the FDA issued a second Complete Response Letter regarding its resubmitted New Drug Application for kidney disease therapy, indicating ongoing third-party manufacturing deficiencies that hindered product approval.
  • Significant Stock Decline: Following this announcement, Unicycive's stock price plummeted from $7.70 per share on June 29 to $4.69 on June 30, representing a 39% drop, which directly impacted investors' asset values and raised concerns about the company's future.
  • Legal Investigation Initiated: The law firm Bragar Eagel & Squire is investigating whether Unicycive has violated federal securities laws, encouraging affected investors to reach out for legal options, highlighting potential legal risks and a decline in investor confidence.
  • Investor Rights Protection: The firm offers no-cost legal consultations to assist long-term shareholders in understanding their rights and potential claims, reflecting the importance of safeguarding investor interests and the necessity for protective measures.
Globenewswire
7.0
07-01Globenewswire
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.
stocktwits
9.0
06-30stocktwits
Unicycive'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.
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.
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
Reason
Noble Capital
Price Target
$60 -> $50
AI Analysis
2026-07-01
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
Reason
Benchmark
Benchmark
Price Target
$18 -> $13
2026-07-01
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 -0.09. 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
-0.09
Current PE
3.44
Overvalued PE
6.65
Undervalued PE
-6.83

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
4.01
Current PS
0.50
Overvalued PS
15.56
Undervalued PS
-7.53

Financials

AI Analysis
Annual
Quarterly

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Whales Holding UNCY

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Holding
UNCY
+27.09%
3M Return

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Frequently Asked Questions

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

The current price of UNCY is 5.43 USD — it has increased 1.31

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 08 2026.

What is Unicycive Therapeutics Inc (UNCY) market cap?

Today UNCY has the market capitalization of 148.74M USD.