Last updated
Revenue
R&D Expenses
Operating CF
Total Assets
Total Liabilities
Equity
Shares Out.
D/E Ratio
Dilution Watch
Financials
52W LOW $3.9352W HIGH $8.74
Volume
23.01 K
Value Traded
3.64 M
Short % Float
15.79%
-3.55%Week
-20.51%1 Month
-21.88%3 Month
-38.61%6 Month
-90.55%5 Year
-90.55%All Time
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Market Cap
115.04 M
EPS (TTM)
-1.26
P/E Ratio
-
Ent. Value
51.95 M
Total Shares
27.86 M
Float Shares
26.62 M
Insiders
4.42%
Institutions
45.10%
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
PoA blends historical approval base rates, trial design score and FDA review track record.
UNCY Catalyst Timeline
Dated clinical, regulatory and corporate events for Unicycive Therapeutics, Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Unicycive Therapeutics, Inc.
140Total events
8Upcoming
30Tier-1 (high impact)
2021 to 2031Coverage
Upcoming catalysts 2
Event history 50
●CRL Resubmissionoxylanthanum carbonateFiledFDA Decision
Unicycive resubmits NDA for oxylanthanum carbonate (OLC) with CMC data from new manufacturing vendor
hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysissource ↗
●Oral PresentationPresentation
Engage with patient and clinical community at medical meetings
●Timing GuidancePresentation
Expected PDUFA date in first half of 2026
hyperphosphatemia in patients with chronic kidney disease on dialysissource ↗
◆PDUFA Dateoxylanthanum carbonateFiledRegulatory Filing
PDUFA target action date for OLC NDA resubmission
hyperphosphatemia in patients with chronic kidney disease on dialysissource ↗
▼Complete Response Letteroxylanthanum carbonateFiledFDA Decision
FDA issued Complete Response Letter in June 2026 regarding first OLC NDA resubmission
hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysissource ↗
▲FDA Filing Acceptedoxylanthanum carbonateFiledRegulatory Filing
FDA acceptance of OLC NDA resubmission
hyperphosphatemia in chronic kidney disease patients on dialysissource ↗
●Timing GuidancePresentation
Planned resubmission of OLC NDA
hyperphosphatemia in patients with chronic kidney disease on dialysissource ↗
▲Oral Presentationoxylanthanum carbonateFiledPresentation
New analysis of OLC data presented at ASN Kidney Week 2025
hyperphosphatemia in patients with chronic kidney disease on dialysissource ↗
●Type A MeetingFDA Meeting
FDA Type A meeting to discuss CRL deficiency
hyperphosphatemia in patients with chronic kidney disease on dialysissource ↗
◆Type A Meetingoxylanthanum carbonateFiledFDA Meeting
Type A Meeting requested with FDA for resolution of CRL for OLC
hyperphosphatemia in chronic kidney disease patients on dialysissource ↗
▲Full Resultsoxylanthanum carbonateFiledClinical Data
Pivotal study data published in CJASN
hyperphosphatemia in chronic kidney disease patients on dialysissource ↗
◆Product LaunchPost-Market
Commercial launch planned for second half of 2025, if approved
hyperphosphatemia in patients with chronic kidney disease on dialysissource ↗
▼Complete Response LetterFDA Decision
FDA issued Complete Response Letter for OLC NDA
hyperphosphatemia in patients with chronic kidney disease on dialysissource ↗
◆PDUFA Dateoxylanthanum carbonateFiledRegulatory Filing
PDUFA action date for OLC NDA
hyperphosphatemia in patients with chronic kidney disease on dialysissource ↗
◆PDUFA DateOLCFiledRegulatory Filing
PDUFA target action date for OLC
hyperphosphatemia in chronic kidney disease on dialysissource ↗
▼Reverse Stock SplitCorporate
1-for-10 reverse stock split effective June 18, 2025; split-adjusted trading begins June 20, 2025
▼Information Requestoxylanthanum carbonateFiledRegulatory Filing
FDA identified cGMP deficiencies at third-party manufacturing vendor
hyperphosphatemia in patients with chronic kidney disease on dialysissource ↗
●Quarterly UpdateCorporate
2025 Annual Meeting of Stockholders time changed to 7:00 a.m. PT on June 9, 2025
▼Complete Response Letteroxylanthanum carbonateFiledFDA Decision
FDA issued Complete Response Letter in June 2025 to the initial OLC NDA submission
hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysissource ↗
●NDA Submissionoxylanthanum carbonateFiledRegulatory Filing
NDA submission for oxylanthanum carbonate
hyperphosphatemia in chronic kidney disease patients on dialysissource ↗
▲FDA Filing Acceptedoxylanthanum carbonateFiledRegulatory Filing
FDA filing acceptance for OLC NDA
hyperphosphatemia in chronic kidney disease patients on dialysissource ↗
▲Orphan Drug DesignationUNI-494Designation
FDA orphan drug designation for UNI-494
prevention of Delayed Graft Function (DGF) in kidney transplant patientssource ↗
●Trial CompletionUNI-494Trial
Phase 1 dose-ranging safety study completed
conditions related to acute kidney injurysource ↗
◆Product LaunchOLCFiledPost-Market
Planned OLC commercial launch
hyperphosphatemia in chronic kidney disease on dialysissource ↗
◆Product Launchoxylanthanum carbonateFiledPost-Market
Anticipated commercial launch of OLC
hyperphosphatemia in chronic kidney disease patients on dialysissource ↗
▲FDA Filing AcceptedOLCFiledRegulatory Filing
OLC NDA accepted by FDA
hyperphosphatemia in chronic kidney disease on dialysissource ↗
◆Oral PresentationOLCFiledPresentation
Late Breaker Poster Presentation on OLC at ASN Kidney Week
hyperphosphatemia in chronic kidney disease on dialysissource ↗
▲Trial CompletionUNI-494Trial
Successful completion of UNI-494 Phase 1 trial
acute kidney injurysource ↗
▲FDA Filing AcceptedRegulatory Filing
FDA accepted NDA for Oxylanthanum Carbonate
hyperphosphatemia in patients with chronic kidney disease on dialysissource ↗
▲Patent GrantedUNI-494IP / Competition
New patent granted for UNI-494 by USPTO
acute kidney injurysource ↗
▲Enrollment CompleteUNI-494Trial
Enrollment completed in UNI-494 Phase 1 dose-ranging study
acute kidney injurysource ↗
●Timing GuidanceOLCFiledPresentation
NDA submission for OLC on track by end of August 2024
hyperphosphatemia in chronic kidney disease patients on dialysissource ↗
●Timing GuidancePresentation
NDA submission anticipated in Q3 2024
hyperphosphatemia in chronic kidney diseasesource ↗
▲Primary Endpoint MetClinical Data
OLC pivotal trial achieves primary tolerability endpoint with low discontinuation rate
hyperphosphatemia in chronic kidney diseasesource ↗
▲Secondary Endpoint DataClinical Data
OLC safety secondary endpoint favorable; no treatment-related SAEs
hyperphosphatemia in chronic kidney diseasesource ↗
●Oral PresentationPresentation
Webcast and conference call to discuss OLC-201 results
hyperphosphatemia in chronic kidney diseasesource ↗
▲Topline Readoutoxylanthanum carbonateFiledClinical Data
Positive pivotal trial results reported for OLC
hyperphosphatemia in chronic kidney disease patients on dialysissource ↗
◆Oral PresentationPresentation
Presentations on OLC at National Kidney Foundation and European Renal Association meetings in May 2024
Past FDA Catalysts and PDUFA Decisions
How UNCY actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-06-30 | Oxylanthanum Carbonate (OLC) | PDUFA Date CRL | PDUFA |
Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision
Drug Pipeline Intelligence
D22 / 100
Pipeline Score
$5M
Pipeline Value
Richly Valued
Valuation Signal
1
Drugs Scored
0.0x
rNPV / MCap
Top 92%
Micro Cap(rank 605 of 658)
Percentile Rank
Unicycive Therapeutics, Inc. faces pipeline headwinds (22/100), with $212M risk-adjusted pipeline value, led by Oxylanthanum Carbonate in Chronic Kidney Disease Requiring Chronic Dialysis (Phase 2).
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Oxylanthanum Carbonate Small moleculeCompletedNCT06218290 | Chronic Kidney Disease Requiring Chronic Dialysis | Phase 2 | COMPLETED | 106 | May 29, 2024 |
Clinical Trial Results
Readouts, endpoints and source filings for every UNCY program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| oxylanthanum carbonate | hyperphosphatemia in patients with chronic kidney disease who are on dialysis | 2025-08-14 | In a pivotal study, oxylanthanum carbonate demonstrated serum phosphate control in over 90% of patients with chronic kidney disease on dialysis, highlighting its potential as a well-tolerated treatment option with a low pill burden.Read More | Unicycive Therapeutics Announces Second Quarter 2025 Financial Results and Provides Business Update - Type A Meeting requested with U.S. Food and Drug Administration (FDA) for resolution of the Complete Response Letter (Read More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Laumas SandeepDirector | Grant/Award | 84,200 84,200 held | $0.00 | 05/14/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in UNCY
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| Octagon Capital Advisors LP | 0.4 % (-42.9 %) | 4.69 M | 1.00 M |
UNCY Institutional Ownership Trends
Options Data
Option Volume
Open Interest
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Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-10-16 | ||||||||||||
Real-Time Option Chain
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| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
CallsPutsLog scale
Competitive positioning
How UNCY ranks across every disease it competes in
Competitive Position is a premium feature
See how UNCY ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
Start free trialUNCY News
UNCYUnicycive Therapeutics Appoints Meredith Manning to Board of Directors
Unicycive Therapeutics has appointed Meredith Manning to its Board of Directors. Manning brings over 25 years of biopharmaceutical experience and will serve on several key committees. Her expertise is expected to support Unicycive's strategic goals, particularly as the company advances its lead product towards potential approval.
Read more →UNCYUnicycive Therapeutics Announces Resubmission of New Drug Application for Oxylanthanum Carbonate
Unicycive Therapeutics has resubmitted its New Drug Application for oxylanthanum carbonate, an oral phosphate binder for hyperphosphatemia in chronic kidney disease patients. The resubmission includes new manufacturing data and stability studies from a compliant vendor. The company expects FDA acceptance within 30 days and aims for a six-month review period. Current cash reserves support operations into the second half of 2027.
Read more →UNCYUnicycive Therapeutics to Present at the H.C. Wainwright 28th Annual Global Investment Conference
Unicycive Therapeutics will present at the H.C. Wainwright 28th Annual Global Investment Conference on September 15, 2026. CEO Shalabh Gupta will lead the presentation, highlighting the company's advancements in therapies for kidney disease. Their lead treatment, oxylanthanum carbonate, targets hyperphosphatemia in dialysis patients, while UNI-494 is aimed at acute kidney injury.
Read more →UNCY▲ +7.8%on this news
Unicycive Therapeutics Announces Second Quarter 2026 Financial Results and Provides Business Update
Unicycive Therapeutics reported its financial results for Q2 2026, highlighting a positive outlook for its oxylanthanum carbonate (OLC) NDA resubmission pending a successful FDA inspection of its third-party manufacturing vendor. The company remains confident in OLC's efficacy and safety, despite receiving a Complete Response Letter regarding previous submissions. Financially, Unicycive has a solid cash position to support its operations into 2027.
Read more →UNCY▼ -39.1%on this news
Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted Oxylanthanum Carbonate (OLC) New Drug Application (NDA)
Unicycive Therapeutics has received a Complete Response Letter from the FDA for its resubmitted NDA for oxylanthanum carbonate (OLC), aimed at treating hyperphosphatemia in chronic kidney disease patients. The FDA did not express concerns about the clinical efficacy or safety data, but noted ongoing deficiencies at a third-party manufacturer. Discussions regarding labeling are currently underway.
Read more →UNCYUnicycive Therapeutics Announces First Quarter 2026 Financial Results and Provides Business Update
Unicycive Therapeutics released its financial results for Q1 2026, showcasing a notable increase in net loss. The company remains optimistic about the FDA's impending decision on its drug oxylanthanum carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients. They maintain sufficient financial resources for operations through 2027, despite a recent drop in income and rising operational expenses. Ongoing discussions with the FDA have been productive, leading to anticipation for the drug's approval and subsequent launch.
Read more →UNCYUnicycive Therapeutics to Present at the 25th Annual Needham Virtual Healthcare Conference
Unicycive Therapeutics will present at the 25th Annual Needham Virtual Healthcare Conference on April 15, 2026. CEO Shalabh Gupta will discuss the company's advancements in therapies for kidney disease, including their lead investigational treatment, oxylanthanum carbonate, which is under FDA review. The company also has a second treatment, UNI-494, aimed at acute kidney injury.
Read more →UNCYUnicycive Therapeutics Announces Full Year 2025 Financial Results and Provides Business Update
Unicycive Therapeutics has announced its financial results for the year ended December 31, 2025, showing a reduced net loss compared to 2024. The company is optimistic about the FDA's acceptance of its New Drug Application resubmission for oxylanthanum carbonate, which targets hyperphosphatemia in chronic kidney disease patients. Despite this positive development, the company faces increased administrative costs, underscoring financial challenges ahead. Overall, Unicycive aims to make a significant impact in the kidney disease treatment landscape.
Read more →UNCY▼ -5.9%on this news
Unicycive Therapeutics to Participate in a Fireside Chat at Guggenheim’s Emerging Outlook: Biotech Summit
Unicycive Therapeutics will have its CEO, Shalabh Gupta, participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit on February 11, 2026. The event aims to discuss the company's advancements in therapies for kidney disease, including its lead treatment under FDA review. This engagement highlights Unicycive's strategic positioning in the biotech sector.
Read more →UNCYUPDATE - Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission
Unicycive Therapeutics announced the FDA's acceptance of its New Drug Application resubmission for oxylanthanum carbonate (OLC), an oral phosphate binder for treating hyperphosphatemia in chronic kidney disease patients. The FDA set a PDUFA target date of June 29, 2026, for a decision. The company ended 2025 with $41.3 million in cash, supporting its commercial preparations for OLC's potential launch.
Read more →UNCYUnicycive Therapeutics Announces Resubmission of New Drug Application (NDA) for Oxylanthanum Carbonate (OLC)
Unicycive Therapeutics has resubmitted its NDA for oxylanthanum carbonate (OLC) to the FDA, targeting treatment for hyperphosphatemia in chronic kidney disease patients on dialysis. The resubmission follows significant progress in resolving previous compliance issues with a third-party manufacturer. The company anticipates a new PDUFA date in the first half of 2026.
Read more →UNCYUnicycive Therapeutics to Participate in Upcoming Investor Events in December
Unicycive Therapeutics, a clinical-stage biotechnology company, announced its participation in two investor events in December 2025. CEO Shalabh Gupta will engage in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference and a virtual presentation with Noble Capital Markets. These events provide a platform for discussing the company's developments in kidney disease therapies.
Read more →UNCY▲ +7.3%on this news· ran to +20% by day 3
Unicycive Therapeutics Announces Third Quarter 2025 Financial Results and Provides Business Update
Unicycive Therapeutics reported its financial results for Q3 2025 and confirmed plans to resubmit the New Drug Application for oxylanthanum carbonate (OLC) by the end of the year. The company presented supportive data at the ASN meeting, highlighting OLC's capabilities in reducing pill burden for patients. Despite a net loss increase, Unicycive concluded the quarter with $42.7 million in cash, ensuring operational support into 2027.
Read more →UNCY▼ -6.5%on this news
Unicycive Therapeutics to Participate in a Fireside Chat at the Guggenheim 2nd Annual Healthcare Innovation Conference
Unicycive Therapeutics announced that CEO Shalabh Gupta will participate in a fireside chat at the Guggenheim 2nd Annual Healthcare Innovation Conference on November 10, 2025. The company is developing therapies for kidney diseases, including oxylanthanum carbonate, which is under FDA review. The event will provide opportunities for investor engagement.
Read more →UNCYUnicycive Therapeutics Announces Upcoming Presentation of New Data Reinforcing the Potential of Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia at the American Society of Nephrology Kidney Week 2025 Conference
Unicycive Therapeutics announced the upcoming presentation of new data on oxylanthanum carbonate (OLC) at the ASN Kidney Week 2025. The data indicates a significant reduction in pill burden for chronic kidney disease patients treated with OLC compared to previous phosphate binders. The study highlights the potential benefits of OLC in managing hyperphosphatemia, with plans for FDA resubmission by year-end.
Read more →UNCY▼ -9.9%on this newsshared move
Unicycive Therapeutics Provides Update from FDA Type A Meeting and Expects to Resubmit OLC NDA Before Year-End
Unicycive Therapeutics has announced an update following its Type A meeting with the FDA regarding its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC). The company plans to resubmit the NDA by year-end after receiving constructive feedback from the FDA, which identified a single manufacturing compliance issue. With over $42 million in cash, Unicycive is well-positioned for future operations while aiming for a potential FDA approval in the first half of 2026. OLC is designed to improve treatment options for patients with hyperphosphatemia on dialysis, promoting better patient adherence through a reduced pill burden.
Read more →About Unicycive Therapeutics, Inc.
Headquarters1975 W. EL CAMINO REAL, SUITE 204, MOUNTAIN VIEW, CA, 94040
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