| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology | ||
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology | ||
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology |
Recent Updates
Recently added Catalysts
Unicycive Therapeutics, Inc.$5.21
-0.02 (-0.37%)
C 43Pipeline Score Fair Value Biotech · Clinical
Market Cap
215.74 M
EPS
-2.06
P/E Ratio
-
Value Trade
3.71 M
SEC Financials
Q1 2026Dilution Risk
R&D Expenses
1.61 M
Operating CF
-6.24 M
Total Assets
64.41 M
Total Liabilities
26.70 M
Equity
37.70 M
D/E Ratio
12,345
-4.94 %
Week
10.99 %
1 Month
25.86 %
3 Month
51.59 %
6 Month
-90.55 %
5 Year
-90.55 %
All Time
Cash Data
Cash Position
54.59 M
Monthly Burn
2.08 M
Runway
24.5 mo
Burn Trend
SEC Filing
May 12, 2026
Overview
Volume
1.13 M
52 Week Range
3.71 - 11
% held by Insiders
9.06 %
% held by Institutions
36.05 %
Enterprise Value
162.09 M
Total Shares
26.69 M
Short %
17.9 %
Float Shares
26.10 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for Unicycive Therapeutics, Inc.
123Total events
1Upcoming
35Tier-1 (high impact)
2021 – 2027Coverage
Upcoming catalysts 1
Event history 122
Jun 2026
●PDUFA DateRegulatory Filing
Expected PDUFA date in first half of 2026
hyperphosphatemia in patients with chronic kidney disease on dialysissource ↗
Jun 29, 2026
◆PDUFA Dateoxylanthanum carbonateRegulatory Filing
PDUFA target action date for OLC NDA resubmission
hyperphosphatemia in patients with chronic kidney disease on dialysissource ↗
Mar 30, 2026
▲FDA Filing Acceptedoxylanthanum carbonateRegulatory Filing
FDA acceptance of OLC NDA resubmission
hyperphosphatemia in chronic kidney disease patients on dialysissource ↗
2026
◆FDA Approvaloxylanthanum carbonateFDA Decision
Potential FDA approval and launch of OLC
hyperphosphatemia in chronic kidney disease patients on dialysissource ↗
Dec 31, 2025
●NDA SubmissionRegulatory Filing
Planned resubmission of OLC NDA
hyperphosphatemia in patients with chronic kidney disease on dialysissource ↗
Nov 12, 2025
▲Oral Presentationoxylanthanum carbonatePresentation
New analysis of OLC data presented at ASN Kidney Week 2025
hyperphosphatemia in patients with chronic kidney disease on dialysissource ↗
Oct 28, 2025
●Type A MeetingFDA Meeting
FDA Type A meeting to discuss CRL deficiency
hyperphosphatemia in patients with chronic kidney disease on dialysissource ↗
Aug 14, 2025
◆Type A Meetingoxylanthanum carbonateFDA Meeting
Type A Meeting requested with FDA for resolution of CRL for OLC
hyperphosphatemia in chronic kidney disease patients on dialysissource ↗
Drug Pipeline Intelligence
C43
Pipeline Score $239M
Pipeline ValueFair Value
Valuation Signal1
Drugs Scored1.1x
rNPV / MCap Top 62%
Micro Cap (rank 347 of 911)
Percentile RankUnicycive Therapeutics, Inc. carries a moderate pipeline score (43/100), with $3.2B risk-adjusted pipeline value, led by Oxylanthanum Carbonate in Chronic Kidney Disease Requiring Chronic Dialysis (Phase 2), across $96B in total addressable markets.
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Oxylanthanum Carbonate Small molecule | Chronic Kidney Disease Requiring Chronic Dialysis | Phase 2 | NCT06218290 | 16% | $3.2B | COMPLETED | 106 | - | - | May 29, 2024 | - | Jun 24, 2024 |
Clinical Trial Results
| Drug Name | Indications | 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 | |
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 | |
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
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in UNCY
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
UNCY Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
| 2026-07-17 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-07-17 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-07-17 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
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 reported its financial results for Q1 2026, highlighting the ongoing FDA review of its oxylanthanum carbonate NDA, with a target action date set for June 29, 2026. The company is preparing for a potential commercial launch of OLC, aimed at addressing hyperphosphatemia in chronic kidney disease patients. Despite a significant net loss, Unicycive remains optimistic about its future prospects.
Read more →UNCYUnicycive Therapeutics Announces First Quarter 2026 Financial Results and Provides Business Update - U.S. Food and Drug Administration (FDA) review of oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission
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 - Oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission under review by U.S. Food and Drug Administration (FDA
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 →UNCYUnicycive Therapeutics Announces Full Year 2025 Financial Results and Provides Business Update
Unicycive Therapeutics reported its financial results for 2025, highlighting the FDA's acceptance of its NDA resubmission for oxylanthanum carbonate (OLC) with a target action date of June 29, 2026. The company is preparing for a potential commercial launch of OLC in Q3 2026, aiming to address hyperphosphatemia in chronic kidney disease patients. Despite a significant net loss, Unicycive has sufficient cash reserves to support operations into 2027.
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 Q3 2025 financial results, highlighting plans to resubmit the NDA for oxylanthanum carbonate (OLC) by year-end. The company presented new data at ASN Kidney Week 2025, showcasing OLC's effectiveness in reducing pill burden. Despite a net loss of $6.0 million, Unicycive maintains a cash runway into 2027, positioning itself for potential regulatory approval and product launch.
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 - Remain on track to resubmit the New Drug Application (NDA) for oxylanthanum carbonate (OLC) by year end - Presented new
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 provided an update following its Type A FDA meeting regarding the resubmission of its New Drug Application for Oxylanthanum Carbonate (OLC). The company plans to address a deficiency related to a third-party manufacturing vendor and aims to resubmit the NDA by the end of 2025. With over $42 million in cash, Unicycive is positioned to navigate the regulatory process and prepare for potential commercialization of OLC.
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 - Cash runway into 2027, which is expected to support application resubmission, potential FDA approval, and l
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 →UNCYUnicycive Therapeutics to Participate in Upcoming Investor Events in September
Unicycive Therapeutics, a clinical-stage biotech firm, announced participation in two investor events in September. CEO Shalabh Gupta will engage in a fireside chat at the H.C. Wainwright 27th Annual Global Investment Conference and a Truist Securities Virtual Fireside Chat. The company is focused on developing therapies for kidney disease, including treatments under FDA review.
Read more →UNCY▼ -13.2%on this news
Unicycive Therapeutics Granted New U.S. Patent for UNI-494 to Treat Chronic Kidney Disease
Unicycive Therapeutics has been granted a new U.S. patent for UNI-494, aimed at treating Chronic Kidney Disease. This patent extends intellectual property protection until 2040 and follows an earlier patent for treating Acute Kidney Injury. The company is also pursuing FDA approval for its lead product, oxylanthanum carbonate, while UNI-494 has completed a Phase 1 clinical study and received Orphan Drug Designation for kidney transplant patients.
Read more →UNCYUnicycive Therapeutics Announces Second Quarter 2025 Financial Results and Provides Business Update
Unicycive Therapeutics reported its Q2 2025 financial results, highlighting a Type A meeting request with the FDA to address a Complete Response Letter regarding oxylanthanum carbonate (OLC). The pivotal study data published indicates OLC's potential for effective phosphate control in patients. Despite a net loss of $6.4 million, the company maintains a strong cash position to support future operations.
Read more →UNCYUnicycive 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 (
Unicycive Therapeutics announced its financial results for Q2 2025 alongside a business update. The company requested a Type A meeting with the FDA to resolve concerns raised in a Complete Response Letter for its lead product, oxylanthanum carbonate (OLC). Recently published data showed that OLC was well tolerated and effective in controlling serum phosphate levels for the majority of patients. Despite a net loss of $6.4 million for the quarter, the company maintains a cash position that should support operations into 2026.
Read more →UNCY▲ +5.2%on this news
Unicycive Therapeutics Announces the Publication of Oxylanthanum Carbonate Pivotal Trial Data in Clinical Journal of the American Society of Nephrology
Unicycive Therapeutics announced the publication of pivotal trial data for oxylanthanum carbonate (OLC) in the Clinical Journal of the American Society of Nephrology. The Phase 2 trial demonstrated that OLC was well tolerated and effectively controlled serum phosphate levels in over 90% of patients with chronic kidney disease on dialysis. The findings support OLC's potential as a new treatment option, emphasizing its low pill burden and favorable safety profile.
Read more →UNCY▲ +6%on this news
Unicycive Therapeutics Regains Compliance with Nasdaq Minimum Bid Price Requirement
Unicycive Therapeutics has announced that it has regained compliance with Nasdaq's minimum bid price requirement following a reverse stock split. As of July 3, 2025, the company's stock has maintained an average closing price of at least $1.00. This compliance update was confirmed by Nasdaq, indicating that the matter is now closed.
Read more →UNCYUnicycive Therapeutics to Present at the H.C. Wainwright 4th Annual Kidney Virtual Conference
Unicycive Therapeutics will present at the H.C. Wainwright 4th Annual Kidney Virtual Conference on July 14, 2025. CEO Shalabh Gupta will participate in a fireside chat, highlighting the company's focus on developing therapies for kidney disease. Their lead treatment is oxylanthanum carbonate, aimed at managing hyperphosphatemia in dialysis patients.
Read more →UNCY▼ -29.9%on this news
Unicycive Therapeutics Announces Receipt of Complete Response Letter for Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis --Complete Response Letter (CRL)
Unicycive Therapeutics has received a Complete Response Letter (CRL) from the FDA for its New Drug Application for Oxylanthanum Carbonate (OLC), aimed at treating hyperphosphatemia in patients with chronic kidney disease on dialysis. The CRL specifically cited deficiencies at a third-party manufacturing vendor not related to OLC itself. However, Unicycive remains optimistic as they have identified a second vendor capable of producing OLC, and they plan to meet with the FDA to discuss the next steps. The company has a cash balance sufficient to sustain operations into 2026.
Read more →UNCY▼ -5%on this news
Unicycive Therapeutics, Inc. Announces Reverse Stock Split Shares Expected to Begin Trading on Split-Adjusted Basis on
Unicycive Therapeutics, Inc. has announced a 1-for-10 reverse stock split set to take effect on June 18, 2025. This decision arises from the need to increase the stock price to meet Nasdaq's minimum requirement of $1.00 for continued listing. The company plans to start trading on a split-adjusted basis on June 20, 2025. All stockholders will uniformly experience the split, which will not alter their percentage ownership or voting power, though it aims to help stabilize the stock's market position.
Read more →UNCY▼ -9%on this newsshared move
Unicycive Therapeutics Regains Compliance with Nasdaq Minimum Bid Price Requirement --Nasdaq compliance follows reverse stock split previously announced on
Unicycive Therapeutics has announced that it has regained compliance with the Nasdaq's minimum bid price requirement following a reverse stock split. As of July 3, 2025, the company's common stock maintained an average closing price of at least $1.00, thus meeting the necessary criteria. This confirmation from Nasdaq indicates that the compliance issue is now resolved, allowing Unicycive to maintain its listing on the exchange.
Read more →UNCY▼ -9%on this newsshared move
Unicycive Therapeutics, Inc. Announces Reverse Stock Split
Unicycive Therapeutics, Inc. announced a 1-for-10 reverse stock split effective June 18, 2025, to increase its stock price and comply with Nasdaq's minimum bid requirement. The split will reduce the number of outstanding shares from approximately 126 million to about 12.6 million. The company aims to maintain its listing on the Nasdaq Capital Market.
Read more →UNCY▼ -40.9%on this news
Unicycive Provides Update on New Drug Application for Oxylanthanum Carbonate to Treat Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis - The U.S. Food and Drug Administration (FDA) identified deficie
Unicycive Therapeutics has provided an update on its New Drug Application for oxylanthanum carbonate (OLC), aimed at treating hyperphosphatemia in patients with chronic kidney disease on dialysis. The FDA has identified deficiencies in cGMP compliance at a third-party manufacturing vendor, which affects discussions on labeling. Despite these setbacks, the company remains confident in OLC's potential, with a final FDA decision expected by June 28, 2025.
Read more →UNCY▼ -40.9%on this news
Unicycive Provides Update on New Drug Application for Oxylanthanum Carbonate to Treat Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis
Unicycive Therapeutics provided an update on its New Drug Application for oxylanthanum carbonate (OLC) aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis. The FDA has identified deficiencies at a third-party manufacturing vendor, which has delayed label discussions. A final decision from the FDA is expected by June 28, 2025.
Read more →UNCYUnicycive Therapeutics to Present at Upcoming Investor Conferences
Unicycive Therapeutics, a clinical-stage biotechnology company, announced upcoming presentations at two virtual investor conferences. CEO Shalabh Gupta will participate in a fireside chat at the Lytham Partners Spring 2025 Investor Conference and a corporate presentation at the Noble Capital Markets 2025 Emerging Growth Virtual Equity Conference. The company is focused on developing therapies for kidney disease, including treatments currently under FDA review.
Read more →UNCYUnicycive Therapeutics Announces Time Change for 2025 Annual Meeting of Stockholders
Unicycive Therapeutics has announced a change in the timing of its 2025 Annual Meeting of Stockholders, which remains scheduled for June 9, 2025, at 7:00 a.m. PDT. The location will stay the same in Los Altos, CA. Stockholders of record as of April 30, 2025, can access participation details via the company's website. Unicycive continues to develop therapies for kidney diseases, including their lead treatment currently under FDA review.
Read more →UNCY▼ -7.8%on this news
Unicycive Therapeutics Announces First Quarter 2025 Financial Results and Provides Business Update - Oxylanthanum carbonate (OLC) New Drug Application (NDA) for hyperphosphatemia in chronic kidney disease patients on dia
Unicycive Therapeutics reported its financial results for Q1 2025, highlighting a transition to profitability with a net income of $0.5 million. The company is preparing for potential FDA approval of oxylanthanum carbonate, aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis. Although R&D expenses decreased significantly, the rise in general and administrative expenses indicates challenges in managing operational costs as they prepare for commercialization. The outlook remains positive but is tempered by potential regulatory hurdles.
Read more →UNCY▼ -7.8%on this news
Unicycive Therapeutics Announces First Quarter 2025 Financial Results and Provides Business Update
Unicycive Therapeutics reported its Q1 2025 financial results, highlighting progress towards FDA approval for oxylanthanum carbonate (OLC) aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis. The FDA has set a PDUFA action date of June 28, 2025, and Unicycive is actively preparing for a potential commercial launch. Recent patient surveys indicate a strong preference for OLC due to its reduced pill burden. Financially, the company showed a net income of $0.5 million, a notable recovery from a significant loss in the previous year.
Read more →UNCYUnicycive Presents New Patient-Level Data Underscoring Challenges Faced with Current Phosphate Binders and Highlighting the Potential of Oxylanthanum Carbonate to Address Barriers to Adherence for Patients with Hyperphosphatemia on Dialysis
Unicycive Therapeutics presented new patient-reported outcomes from its Phase 2 trial of oxylanthanum carbonate (OLC) at the NKF Spring Clinical Meetings. The data show that OLC significantly improves patient satisfaction and adherence compared to traditional phosphate binders. Key findings include a 50% reduction in pill burden and a preference for OLC among the majority of patients surveyed.
Read more →UNCY▼ -5%on this news
Unicycive Therapeutics to Present at the 24th Annual Needham Virtual Healthcare Conference
Unicycive Therapeutics will present at the 24th Annual Needham Virtual Healthcare Conference on April 7, 2025. CEO Shalabh Gupta will discuss the company's advancements in kidney disease therapies, including their lead drug candidate, oxylanthanum carbonate (OLC). OLC is currently under FDA review with a target action date of June 28, 2025, following positive trial results.
Read more →UNCY▼ -6.4%on this newsshared move
Unicycive Therapeutics Announces Full Year 2024 Financial Results and Provides Business Update
Unicycive Therapeutics reported its financial results for 2024, highlighting the ongoing review of its New Drug Application for oxylanthanum carbonate (OLC) by the FDA, with a target action date set for June 28, 2025. The company is preparing for a commercial launch of OLC, which addresses hyperphosphatemia in chronic kidney disease patients. Despite a net loss increase, Unicycive remains optimistic about its pipeline and market potential.
Read more →UNCY▼ -6.4%on this newsshared move
Unicycive Therapeutics Announces Full Year 2024 Financial Results and Provides Business Update - Oxylanthanum carbonate (OLC) New Drug Application for hyperphosphatemia in chronic kidney disease patients on dialysis unde
Unicycive Therapeutics reported its financial results for the year ending December 31, 2024, highlighting ongoing developments related to oxylanthanum carbonate (OLC), currently under FDA review. The company expects OLC to provide an important new treatment for hyperphosphatemia in chronic kidney disease patients. Preparations for a commercial launch are underway, targeting late 2025. However, Unicycive faces challenges with increased net losses and rising R&D expenses, indicating a need for careful financial management moving forward.
Read more →UNCYUnicycive to Highlight Patient Reported Outcomes Data at Upcoming Medical Meetings Showing Oxylanthanum Carbonate Reduced Pill Burden and Improved Adherence in Treatment of Hyperphosphatemia
Unicycive Therapeutics announced it will present data from its pivotal UNI-OLC-201 study at three upcoming medical meetings. The study highlights the potential of oxylanthanum carbonate (OLC) in improving adherence and reducing pill burden for patients with hyperphosphatemia. The FDA has accepted Unicycive's NDA for OLC, with a target action date set for June 28, 2025.
Read more →UNCYUnicycive Therapeutics Announces the Publication of Preclinical Data on Synergies Between Oxylanthanum Carbonate and Tenapanor in American Society of Nephrology Journal Kidney360
Unicycive Therapeutics has published preclinical data in Kidney360, demonstrating that the combination of oxylanthanum carbonate (OLC) and tenapanor significantly reduces urinary phosphate excretion compared to either drug alone. This combination therapy may offer a new approach to managing hyperphosphatemia in patients undergoing dialysis. The findings suggest potential benefits in patient adherence due to OLC's favorable formulation.
Read more →UNCY▼ -5.4%on this news
Unicycive Therapeutics Announces the Publication of Patient Perspectives on Phosphate Management in the Journal of Nephrological Science
Unicycive Therapeutics has published a review in the Journal of Nephrological Science, focusing on patient perspectives regarding phosphate management in chronic kidney disease. The publication identifies key barriers to adherence, such as large pill sizes and high pill burdens, and emphasizes the need for patient-centered approaches. The company's product, Oxylanthanum Carbonate (OLC), aims to address these challenges and improve patient outcomes.
Read more →UNCYUnicycive Therapeutics Announces Publication of Positive Oxylanthanum Carbonate (OLC) Dose Escalation Data in Clinical and Translational Science
Unicycive Therapeutics announced the publication of positive data from its Phase 1 dose escalation study of oxylanthanum carbonate (OLC) in healthy volunteers. The study showed that OLC was well tolerated and effectively reduced phosphate absorption. The findings are crucial for the company's New Drug Application currently under FDA review, with a PDUFA date set for June 28, 2025.
Read more →UNCYUnicycive Therapeutics Announces Publication of Oxylanthanum Carbonate (OLC) Positive Bioequivalence Data in Clinical Therapeutics
Unicycive Therapeutics announced the publication of positive bioequivalence data for its oxylanthanum carbonate (OLC) in the peer-reviewed journal Clinical Therapeutics. The study demonstrated that OLC is pharmacodynamically equivalent to lanthanum carbonate, with both treatments being well tolerated. The company is preparing for a commercial launch of OLC in 2025, following its NDA submission.
Read more →UNCYUnicycive Therapeutics to Participate in Two Upcoming Investor Conferences Including a Fireside Chat at the Piper Sandler 36th Annual Healthcare Conference
Unicycive Therapeutics announced participation in two upcoming investor conferences, featuring CEO Shalabh Gupta. The company is focused on developing therapies for kidney disease, with its lead candidate, oxylanthanum carbonate (OLC), showing positive trial results. An NDA for OLC is under FDA review, with a target action date set for June 28, 2025.
Read more →UNCYUnicycive Announces Third Quarter 2024 Financial Results and Provides Business Update
Unicycive Therapeutics announced its financial results for Q3 2024, highlighting significant progress in its drug development pipeline. The FDA accepted the NDA for oxylanthanum carbonate (OLC), targeting approval by June 28, 2025. Additionally, the company successfully completed the Phase 1 trial for UNI-494, aimed at treating acute kidney injury. Unicycive is preparing for the commercialization of OLC and plans to advance UNI-494 to Phase 2.
Read more →UNCYUnicycive Announces Third Quarter 2024 Financial Results and Provides Business Update - OLC New Drug Application (NDA) Accepted by the FDA with a PDUFA Target Action Date of
Unicycive Therapeutics reported its financial results for the third quarter of 2024, stating that its New Drug Application (NDA) for oxylanthanum carbonate (OLC) has been accepted by the FDA, with a PDUFA action date set for June 28, 2025. The company is preparing for the commercialization of OLC, aiming for a market launch in 2025. Additionally, Unicycive announced the successful completion of a Phase 1 trial for its second asset, UNI-494, which targets acute kidney injury, and plans to discuss the pathway for further clinical development with the FDA. Financially, Unicycive showed a decreased net loss compared to the same quarter last year, along with a solid cash position of $32.3 million.
Read more →UNCY▼ -9.2%on this newsshared move
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 Kidney Disease on Dialysis - FDA set
Unicycive Therapeutics has announced the acceptance of its New Drug Application by the U.S. FDA for Oxylanthanum Carbonate (OLC) to treat hyperphosphatemia in chronic kidney disease patients on dialysis. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025. If approved, OLC could significantly reduce the treatment burden for patients, requiring fewer pills per dose. Unicycive is also preparing for a commercial launch in 2025, contingent on FDA approval.
Read more →UNCY▲ +20.2%on this news
Unicycive Therapeutics Delivers Multiple Poster Presentations Highlighting Development Progress on Oxylanthanum Carbonate (OLC) and UNI-494 at the American Society of Nephrology (ASN) Kidney Week 2024
Unicycive Therapeutics delivered multiple presentations at ASN Kidney Week 2024, showcasing significant progress in the development of oxylanthanum carbonate (OLC) and UNI-494. The pivotal trial for OLC demonstrated over 90% effectiveness in controlling serum phosphate levels in CKD patients on dialysis. Additionally, the company plans to meet with the FDA to discuss Phase 1 results for UNI-494.
Read more →UNCY▲ +11.4%on this news
Unicycive Therapeutics to Participate in a Fireside Chat at the 2024 Maxim Healthcare Virtual Summit on October 17, 2024
Unicycive Therapeutics announced that its CEO, Dr. Shalabh Gupta, will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit on October 17, 2024. The event will be accessible via a live and archived webcast on the company's website. Unicycive is known for developing therapies for kidney diseases, including its lead drug candidate, oxylanthanum carbonate.
Read more →UNCYUnicycive Therapeutics Announces Late-Breaker Poster Presentation on Oxylanthanum Carbonate (OLC) at the American Society of Nephrology (ASN) Kidney Week 2024
Unicycive Therapeutics announced a Late-Breaker poster presentation for oxylanthanum carbonate (OLC) at the ASN Kidney Week 2024. The company will present additional findings on OLC and UNI-494. OLC aims to improve treatment for hyperphosphatemia in chronic kidney disease patients, addressing a significant unmet need in the market.
Read more →UNCYUnicycive Therapeutics Successfully Completes UNI-494 Phase 1 Study in Healthy Volunteers
Unicycive Therapeutics has successfully completed the Phase 1 study of UNI-494, demonstrating its safety and tolerability in healthy volunteers. The study's results will inform the design of a potential Phase 2 trial for acute kidney injury. The company plans to meet with the FDA to discuss these findings and next steps.
Read more →UNCY▼ -7.5%on this news
Unicycive Therapeutics to Participate in a Fireside Chat at the Virtual Lytham Partners Fall 2024 Investor Conference on October 1, 2024
Unicycive Therapeutics will have its CEO, Shalabh Gupta, participate in a fireside chat at the virtual Lytham Partners Fall 2024 Investor Conference on October 1, 2024. This event will provide insights into the company's developments in kidney disease therapies, including their lead candidate for hyperphosphatemia. The webcast will be accessible live and archived for three months.
Read more →UNCY▲ +9.5%on this news
Unicycive Therapeutics to Present at the Virtual Life Sciences Investor Forum on September 19, 2024
Unicycive Therapeutics announced that CEO Shalabh Gupta will present a corporate update at the Virtual Life Sciences Investor Forum on September 19, 2024. The presentation will provide insights into the company's developments in therapies for kidney disease. Investors are encouraged to pre-register for the event to facilitate participation.
Read more →UNCYUnicycive Therapeutics to Present at the H.C. Wainwright 26th Annual Global Investment Conference
Unicycive Therapeutics announced that CEO Shalabh Gupta will present a corporate update at the H.C. Wainwright 26th Annual Global Investment Conference on September 10, 2024. The presentation will provide insights into the company's developments, including their lead drug candidate for hyperphosphatemia in chronic kidney disease patients. The event will be accessible via a live and archived webcast.
Read more →UNCY▼ -5.9%on this newsshared move
Unicycive Therapeutics Announces Submission of the New Drug Application (NDA) to the U.S. FDA for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis
Unicycive Therapeutics has submitted a New Drug Application (NDA) to the FDA for Oxylanthanum Carbonate (OLC), targeting hyperphosphatemia in chronic kidney disease patients on dialysis. The company is utilizing the 505(b)(2) regulatory pathway and has received a waiver for PDUFA fees, saving around $4 million. OLC is designed to improve patient adherence by reducing the number of pills required.
Read more →UNCYUnicycive Therapeutics to Present Three Posters at the American Society of Nephrology (ASN) Kidney Week 2024
Unicycive Therapeutics announced that it will present three posters at the ASN Kidney Week 2024 in San Diego. The presentations will focus on their product candidates, oxylanthanum carbonate (OLC) and UNI-494, which aim to address significant unmet needs in kidney disease treatment. The company is seeking FDA approval for OLC, which has shown promising results in clinical studies.
Read more →UNCY▲ +34%on this news· ran to +59% by day 3
Unicycive Announces Second Quarter 2024 Financial Results and Provides Business Update - On Track to Submit OLC New Drug Application (NDA) by End of August 2024
Unicycive Therapeutics reported its financial results for Q2 2024, announcing success in its oxylanthanum carbonate (OLC) pivotal trial, which is critical for its New Drug Application (NDA) submission by the end of August 2024. The trial confirmed the drug's tolerability and demonstrated phosphate control in a significant proportion of patients. However, the company also noted a rise in R&D expenses and continues to face financial challenges, including reported losses. The firm remains optimistic about its potential products, including a new treatment for acute kidney injury.
Read more →UNCY▲ +34%on this news· ran to +59% by day 3
Unicycive Announces Second Quarter 2024 Financial Results and Provides Business Update
Unicycive Therapeutics reported positive financial results for Q2 2024, highlighting successful outcomes from its pivotal trial of oxylanthanum carbonate (OLC) for treating hyperphosphatemia in dialysis patients. The company is on track to submit a New Drug Application (NDA) by the end of August 2024. Additionally, a new patent for UNI-494 was granted, supporting its development for acute kidney injury.
Read more →UNCY▼ -7%on this news
Unicycive Therapeutics Granted Patent on UNI-494 to Treat Acute Kidney Injury by the United States Patent and Trademark Office (USPTO)
Unicycive Therapeutics has been granted a patent for UNI-494 by the USPTO, ensuring protection until 2040. This patent covers a method for treating acute kidney injury and contrast-induced nephropathy. UNI-494 is currently undergoing a Phase 1 clinical trial and has received Orphan Drug Designation for its application in kidney transplant patients.
Read more →UNCYUnicycive Therapeutics to Participate in Fireside Chat at the H.C. Wainwright 3rd Annual Kidney Virtual Conference
Unicycive Therapeutics announced that CEO Shalabh Gupta will participate in a Fireside Chat at the H.C. Wainwright 3rd Annual Kidney Virtual Conference on July 15, 2024. This event will provide insights into the company's developments in therapies for kidney diseases, including their lead drug candidate, oxylanthanum carbonate. The webcast will be available live and archived for three months.
Read more →UNCYUnicycive Therapeutics Announces Initial Positive Patient Satisfaction Findings from Pivotal Clinical Trial of Oxylanthanum Carbonate (OLC)
Unicycive Therapeutics reported positive findings from the UNI-OLC-201 pivotal trial, indicating that 79% of patients preferred oxylanthanum carbonate (OLC) over their previous phosphate binder therapy. The trial demonstrated a significant reduction in pill burden, with patients taking half as many pills daily after switching to OLC. These results suggest improved patient satisfaction and adherence to treatment.
Read more →UNCY▲ +7.8%on this news
Unicycive Therapeutics Joins Russell Microcap® Index
Unicycive Therapeutics has been added to the Russell Microcap Index as of July 1, 2024, following the annual reconstitution of the Russell US Indexes. This inclusion is seen as a significant milestone for the company, reflecting its progress and positive clinical trial results for its drug candidate oxylanthanum carbonate. The addition is expected to enhance visibility and potentially benefit shareholders.
Read more →UNCY▼ -26.8%on this news
Unicycive Therapeutics Achieves Study Objective in Oxylanthanum Carbonate (OLC) Pivotal Clinical Trial - Successfully Established Favorable Tolerability and Safety of OLC - - New Drug Application (NDA) Submission Anticip
Unicycive Therapeutics announced successful results from the Oxylanthanum Carbonate (OLC) pivotal clinical trial, demonstrating favorable tolerability and safety in patients with chronic kidney disease. The trial showed a low rate of discontinuation due to adverse events, with only 1.4% of patients in the evaluable population discontinuing treatment. Following the washout of previous phosphate binders, 90% of patients achieved the target phosphate levels, supporting the potential for OLC to be a competitive treatment option. The company anticipates submitting a New Drug Application (NDA) based on these promising findings.
Read more →UNCY▼ -26.8%on this news
Unicycive Therapeutics Achieves Study Objective in Oxylanthanum Carbonate (OLC) Pivotal Clinical Trial
Unicycive Therapeutics announced positive results from its pivotal clinical trial of Oxylanthanum Carbonate (OLC), demonstrating favorable tolerability and safety in chronic kidney disease patients. The trial showed a low discontinuation rate due to adverse events and a significant percentage of patients achieving target phosphate levels. The company plans to submit a New Drug Application to the FDA in Q3 2024.
Read more →UNCY▼ -11.7%on this news
Unicycive Therapeutics Delivers Multiple Presentations on Oxylanthanum Carbonate (OLC) and UNI-494 at the European Renal Association Congress
Unicycive Therapeutics presented promising data on oxylanthanum carbonate (OLC) and UNI-494 at the European Renal Association Congress. OLC showed superior phosphate-lowering effects compared to tenapanor in preclinical models, while UNI-494 demonstrated potential in preventing delayed graft function related to acute kidney injury. The company outlined ongoing clinical trials for both candidates.
Read more →UNCYUnicycive Therapeutics to Participate in a Fireside Chat at the Lytham Partners Spring 2024 Investor Conference
Unicycive Therapeutics will have its CEO, Dr. Shalabh Gupta, participate in a Fireside Chat at the Lytham Partners Spring 2024 Investor Conference on May 30, 2024. The event will be accessible via a live and archived webcast on the company's website. Unicycive is focused on developing therapies for kidney diseases, including its lead candidate for hyperphosphatemia treatment.
Read more →UNCYUnicycive Therapeutics Presents Bioequivalence Data on Oxylanthanum Carbonate (OLC) at the National Kidney Foundation Spring Clinical Meeting
Unicycive Therapeutics presented two posters at the NKF Spring Clinical Meeting, highlighting the bioequivalence of oxylanthanum carbonate (OLC) to lanthanum carbonate (LC) and the perceptions of renal dieticians regarding phosphate binder compliance. The study confirmed similar urinary phosphate excretion outcomes between OLC and LC, supporting OLC's potential for FDA approval. The findings suggest OLC's smaller tablet size may enhance patient adherence.
Read more →UNCYUnicycive Announces First Quarter 2024 Financial Results and Provides Business Update - On Track to Provide Topline Data from the Ongoing Pivotal Clinical Trial with Oxylanthanum Carbonate (OLC) in Q2 2024 - - Multiple P
Unicycive Therapeutics reported its financial results for Q1 2024, highlighting its progress in clinical trials for oxylanthanum carbonate (OLC) and UNI-494. The company anticipates topline data from the OLC trial in Q2 2024, aimed at treating chronic kidney disease patients. Despite a net loss increase to $21.2 million, Unicycive's cash position remains strong at $48.9 million, allowing for continued funding of operations into 2026. The company also plans to present findings at upcoming nephrology meetings.
Read more →UNCYUnicycive Announces First Quarter 2024 Financial Results and Provides Business Update
Unicycive Therapeutics reported its financial results for Q1 2024, highlighting progress in its pivotal clinical trial for oxylanthanum carbonate (OLC) and the development of UNI-494. The company anticipates topline data from the OLC trial in Q2 2024 and is actively presenting at major nephrology meetings. Despite a net loss increase, Unicycive maintains a strong cash position to support ongoing operations.
Read more →UNCYUnicycive Therapeutics to Present at the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference
Unicycive Therapeutics, a clinical-stage biotech firm, announced that CEO Shalabh Gupta will present a company update at the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference on April 18, 2024. The presentation will provide insights into their ongoing developments in kidney disease therapies, including their lead candidate, oxylanthanum carbonate. A webcast of the event will be available for three months.
Read more →UNCY▼ -5.5%on this news
Unicycive Announces Full Year 2023 Financial Results and Provides Business Update - Oxylanthanum Carbonate (OLC) Topline Data Expected in Q2 2024 - - UNI-494 Granted Orphan Drug Designation in Delayed Graft Function of A
Unicycive Therapeutics has reported its financial results for the year ending December 31, 2023, highlighting a net loss of $31.4 million. Notably, the company announced that its drug candidate UNI-494 has received Orphan Drug Designation for preventing delayed graft function. Unicycive also expects to have topline data from its pivotal clinical trial of oxylanthanum carbonate (OLC) in Q2 2024, which could support a future New Drug Application. Recent funding has provided the company with sufficient resources to continue operations through 2026.
Read more →UNCY▼ -5.5%on this news
Unicycive Therapeutics Announces Full Year 2023 Financial Results and Provides Business Update
Unicycive Therapeutics reported its financial results for 2023, highlighting significant advancements in its clinical programs. The company completed enrollment in a pivotal trial for oxylanthanum carbonate (OLC) and received orphan drug designation for UNI-494. Despite a net loss increase, Unicycive secured $50 million in funding to support ongoing operations and trials.
Read more →UNCYUnicycive Therapeutics to be Featured in Multiple Presentations at the Upcoming European Renal Association Congress
Unicycive Therapeutics will present multiple studies on its drug candidates OLC and UNI-494 at the upcoming European Renal Association Congress in May 2024. The presentations will include preclinical data and updates on ongoing clinical trials. OLC aims to improve treatment for hyperphosphatemia in chronic kidney disease, while UNI-494 is being developed for acute kidney injury.
Read more →UNCYUnicycive Announces $50 Million Private Placement Unicycive Therapeutics, Inc. Thu
Unicycive Therapeutics, Inc. announced a $50 million private placement with investors including Octagon Capital and Great Point Partners. The funds will support the clinical development of their lead drug, oxylanthanum carbonate, aimed at treating hyperphosphatemia in kidney disease patients. The private placement is set to close on March 18, 2024, subject to customary conditions. This financing reflects strong confidence in Unicycive's therapeutic pipeline and future plans for a commercial launch, pending FDA approval.
Read more →UNCYUnicycive Announces $50 Million Private Placement
Unicycive Therapeutics has announced a $50 million private placement of its Series B Convertible Preferred Stock, aimed at advancing its clinical development pipeline, particularly for Oxylanthanum Carbonate (OLC). The financing is led by Octagon Capital and Great Point Partners, with the transaction expected to close on March 18, 2024. Proceeds will support the ongoing pivotal trial of OLC and potential FDA submission for treating hyperphosphatemia in kidney disease patients.
Read more →UNCYUnicycive Therapeutics Delivers Both an Oral and Poster Presentation on UNI-494 at the AKI and CRRT Conference
Unicycive Therapeutics has presented promising data on UNI-494 at the AKI and CRRT 2024 conference. The drug has shown statistically significant results in preclinical models for preventing delayed graft function after kidney transplantation. The Phase 1 clinical trial's single ascending dose portion has been completed successfully, with positive safety and tolerability data. UNI-494 has also received orphan drug designation from the FDA.
Read more →UNCYUnicycive Therapeutics Completes Enrollment in Pivotal Clinical Trial for Oxylanthanum Carbonate (OLC)
Unicycive Therapeutics has completed enrollment in its pivotal clinical trial for Oxylanthanum Carbonate (OLC), aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis. The trial will evaluate the tolerability, safety, and pharmacokinetics of OLC, with topline data expected in Q2 2024. A successful outcome could lead to an NDA filing with the FDA.
Read more →UNCY▼ -6.9%on this newsshared move
Unicycive Therapeutics Announces Orphan Drug Designation Granted for UNI-494 by the U.S. Food and Drug Administration for the Prevention of Delayed Graft Function in Kidney Transplant Patients
Unicycive Therapeutics announced that the FDA has granted orphan drug designation to UNI-494 for preventing Delayed Graft Function in kidney transplant patients. This designation is significant as it addresses a critical unmet medical need, with no current FDA-approved treatments available. UNI-494 functions by restoring mitochondrial function and is currently undergoing a Phase 1 clinical trial.
Read more →UNCY▲ +10.5%on this news· ran to +39% by day 3
Unicycive Therapeutics to Present Two Posters on Oxylanthanum Carbonate (OLC) at the Upcoming National Kidney Foundation Spring Clinical Meeting
Unicycive Therapeutics will present two posters on oxylanthanum carbonate (OLC) at the National Kidney Foundation Spring Clinical Meeting in May 2024. The presentations will include new data from a bioequivalence study and insights from a survey on patient compliance with phosphate binders. OLC aims to provide a better treatment option for hyperphosphatemia in chronic kidney disease patients.
Read more →UNCY▲ +7.4%on this news
Unicycive Therapeutics Announces Both an Oral and Poster Presentation to be Delivered on UNI-494 at the Upcoming AKI and CRRT Conference
Unicycive Therapeutics announced two presentations on UNI-494 at the upcoming AKI and CRRT 2024 conference. The presentations will cover the efficacy of UNI-494 in animal models of acute kidney injury and the design of its ongoing Phase 1 clinical trial. The company aims to build data on UNI-494 while focusing on its lead drug candidate, OLC.
Read more →UNCY▲ +18.3%on this news
Unicycive Therapeutics Issues Shareholder Letter to Highlight Corporate Progress and Key Upcoming Milestones
Unicycive Therapeutics has issued a shareholder letter highlighting its progress and upcoming milestones, particularly the pivotal trial for its lead drug candidate, Oxylanthanum Carbonate (OLC). The company anticipates reporting topline data in Q2 2024, which could lead to a New Drug Application submission mid-year. OLC aims to address the hyperphosphatemia market, significantly reducing the pill burden for patients on dialysis.
Read more →UNCYUnicycive Therapeutics Announces Enrollment of First Patient in Pivotal Clinical Trial for Oxylanthanum Carbonate (OLC) in Patients with Chronic Kidney Disease on Dialysis
Unicycive Therapeutics has enrolled the first patient in a pivotal clinical trial for Oxylanthanum Carbonate (OLC), aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis. The trial will evaluate 60 participants, with results expected in the second quarter of 2024. This study is crucial for filing a New Drug Application (NDA) under the 505(b)(2) regulatory pathway.
Read more →UNCY▼ -5.4%on this news
Unicycive Therapeutics to Participate in Two Investor Conferences in December 2023
Unicycive Therapeutics will participate in two investor conferences in December 2023. CEO Shalabh Gupta is scheduled to present at the Noble Capital Markets 19th Annual Emerging Growth Equity Conference on December 4 and at the 2023 Benchmark Discovery One-on-One Investor Conference on December 7. The company focuses on developing therapies for kidney diseases.
Read more →UNCYUnicycive Announces Third Quarter 2023 Financial Results and Provides Business Update Reached Alignment with the FDA on the Data Package Requirements to File NDA for oxylanthanum carbonate (OLC) OLC Pivotal Clinical Tria
Unicycive Therapeutics reported its third-quarter financial results and announced FDA alignment on the data package for its oxylanthanum carbonate (OLC) NDA filing. The pivotal clinical trial for OLC is expected to begin before the end of the year, aiming to provide a needed treatment for chronic kidney disease patients. The company emphasizes its commitment to develop therapies with enhanced patient adherence due to a reduced pill burden. However, Unicycive faced a significant decline in licensing revenues and a net loss, signaling ongoing financial challenges.
Read more →UNCYUnicycive Announces Third Quarter 2023 Financial Results and Provides Business Update
Unicycive Therapeutics reported its Q3 2023 financial results and announced significant progress in its clinical development plan for oxylanthanum carbonate (OLC). The company has reached alignment with the FDA regarding the data package required for filing a New Drug Application (NDA) and plans to initiate a pivotal clinical trial before the end of the year. Despite a net loss of $4.4 million, Unicycive remains optimistic about OLC's potential in treating chronic kidney disease.
Read more →UNCY▼ -7.9%on this news· ran to -29% by day 3
Unicycive Therapeutics Reaches Alignment with the FDA on Path to File New Drug Application for Oxylanthanum Carbonate (OLC) - Pivotal clinical trial expected to initiate before year end
Unicycive Therapeutics has aligned with the FDA regarding the requirements for filing a New Drug Application for Oxylanthanum Carbonate (OLC). This agreement allows the pivotal clinical trial, which aims to evaluate tolerability in patients with chronic kidney disease, to begin before the year's end. The trial will involve 60 participants and is designed to gather important clinical data necessary for OLC's NDA submission. With supportive cash reserves, Unicycive is optimistic about advancing its therapeutic candidate in the market.
Read more →UNCY▼ -7.9%on this news· ran to -29% by day 3
Unicycive Therapeutics Reaches Alignment with the FDA on Path to File New Drug Application for Oxylanthanum Carbonate (OLC)
Unicycive Therapeutics has announced alignment with the FDA regarding the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC). The company plans to initiate a pivotal clinical trial involving 60 participants by the end of 2023, focusing on the drug's tolerability. The NDA will utilize the 505(b)(2) regulatory pathway, referencing the approved drug Fosrenol. Positive results from this trial are expected to enhance the safety data package for OLC.
Read more →UNCYUnicycive Therapeutics Strengthens Board of Directors with Appointment of Sara Kenkare-Mitra, PhD - Appointment adds decades of drug development experience from a seasoned executive
Unicycive Therapeutics has appointed Dr. Sara Kenkare-Mitra, a seasoned executive with over 25 years of drug development experience, to its Board of Directors as of September 6, 2023. This strategic appointment aims to enhance the company’s growth trajectory as it prepares to file a New Drug Application for its lead candidate, oxylanthanum carbonate, and advance another candidate, UNI-494. Dr. Kenkare-Mitra’s extensive background includes a significant role at Genentech, where she helped in filing multiple INDs and approvals for various medicines. Her expertise is anticipated to be a valuable asset as Unicycive continues to address unmet medical needs in kidney diseases.
Read more →UNCYUnicycive Therapeutics Strengthens Board of Directors with Appointment of Sara Kenkare-Mitra, PhD
Unicycive Therapeutics has appointed Dr. Sara Kenkare-Mitra to its Board of Directors, effective September 6, 2023. Dr. Kenkare-Mitra brings over 25 years of experience in drug development, having played a key role in numerous IND filings and drug approvals. Her expertise is expected to enhance Unicycive's strategic initiatives, particularly in advancing their drug candidates for kidney diseases.
Read more →UNCYUnicycive Therapeutics Featured on Nasdaq Amplify Issuer Spotlight Series
Unicycive Therapeutics, a clinical-stage biotech firm, was featured in the Nasdaq Amplify Issuer Spotlight series. CEO Shalabh Gupta discussed the company's efforts in developing therapies for kidney disease, including their lead drug candidate, oxylanthanum carbonate, aimed at treating hyperphosphatemia. The interview highlights the challenges faced by small-cap companies in the biotech sector.
Read more →UNCYUnicycive Announces Second Quarter 2023 Financial Results and Provides Business Update
Unicycive Therapeutics reported its financial results for Q2 2023, highlighting progress in its lead asset, Oxylanthanum Carbonate (OLC), which aims to improve medication adherence for chronic kidney disease patients. The company anticipates FDA feedback on the OLC program by Fall 2023. Additionally, preclinical data for UNI-494 suggests potential benefits in treating acute kidney injury. Despite these advancements, the company reported an increased net loss compared to the previous year.
Read more →UNCYUnicycive Announces Second Quarter 2023 Financial Results and Provides Business Update Recent Data Publications Highlight the Benefits of Oxylanthanum Carbonate (OLC) to Improve Medication Adherence and Quality of Life f
Unicycive Therapeutics, Inc. announced its financial results for the second quarter of 2023, reporting a net loss of $4.4 million. The company has highlighted the potential benefits of its lead product, Oxylanthanum Carbonate (OLC), in improving patient adherence and quality of life for those with chronic kidney disease. Unicycive plans to seek FDA feedback in Fall 2023 and is progressing with its Phase 1 trial for UNI-494, aimed at treating acute kidney injury. The ongoing development efforts are expected to pave the way for future clinical studies and potential drug approvals.
Read more →UNCYUnicycive Therapeutics to Participate in the H.C. Wainwright 2nd Annual Kidney Conference
Unicycive Therapeutics announced its participation in the H.C. Wainwright 2nd Annual Kidney Conference, where CEO Shalabh Gupta will engage in a fireside chat. The event, scheduled for July 25, 2023, will focus on glomerular diseases, emphasizing the company's commitment to addressing kidney health. The conference will be accessible via a live and archived webcast on Unicycive's website.
Read more →UNCYUnicycive Therapeutics Announces Publication of Positive Comparison of Oxylanthanum Carbonate to Commercially Available Phosphate Binders in the American Journal of Nephrology
Unicycive Therapeutics announced the publication of positive results for oxylanthanum carbonate (OLC) in the American Journal of Nephrology. The study indicates that OLC has the lowest daily dose volume compared to other phosphate binders, potentially improving adherence in chronic kidney disease patients. The USAN name for OLC has been adopted, replacing lanthanum dioxycarbonate.
Read more →UNCYUnicycive Therapeutics Provides Regulatory Update on Lanthanum Dioxycarbonate Program
Unicycive Therapeutics has updated investors on its New Drug Application for Lanthanum Dioxycarbonate (LDC), aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis. The FDA has requested additional information, including a risk assessment, after reviewing toxicity data from a recent study. Despite these hurdles, Unicycive's leadership remains optimistic about the drug's potential and is committed to collaborating with the FDA. The Company plans to provide further updates in the coming months.
Read more →UNCYUnicycive Announces First Quarter 2023 Financial Results and Provides Business Update Closed on previously announced transformational fundraising that included $30 million financing upfront with up to an additional $100
Unicycive Therapeutics reported its first quarter 2023 financial results, highlighting a significant $30 million upfront financing as part of a larger $130 million funding strategy. The company plans to submit a New Drug Application for its kidney treatment Renazorb by Q3 2023, with an anticipated market launch in 2024. Despite strong financings, Unicycive reported a net loss of $14.6 million for the quarter, attributed to increased R&D costs. The company continues to focus on advancing its treatments for kidney disease amidst market competition and clinical trial uncertainties.
Read more →UNCY▲ +11.7%on this news
Unicycive Announces Full Year 2022 Financial Results and Provides Business Update Closed transformational fundraise that included $30 million financing upfront with up to an additional $100 million tied to satisfaction o
Unicycive Therapeutics reported its full year financial results for 2022, highlighting a transformational fundraise that secured $30 million upfront, with potential for an additional $100 million tied to milestones. The company is on track to file a New Drug Application for its lead drug, Renazorb, by mid-2023, which aims to address hyperphosphatemia in chronic kidney disease patients. While the market opportunity for Renazorb is promising, the company also reported an increased net loss and a significant decrease in cash reserves, raising concerns about its financial stability.
Read more →UNCY▲ +153.1%on this news· ran to +320% by day 3
Unicycive Announces up to $130 Million Financing to Commercialize and Launch Investigational New Drug Renazorb $30 million financing upfront with up to an additional $100 million tied to satisfaction of milestones Led by
Unicycive Therapeutics announced a financing deal totaling up to $130 million to support the commercialization of its investigational drug, Renazorb, intended for treating hyperphosphatemia in patients with kidney disease. The financing includes an upfront amount of $30 million and additional funds contingent on the achievement of specific milestones. The company remains on track to submit a New Drug Application to the FDA mid-year. Renazorb aims to address current limitations in phosphate-lowering agents for dialysis patients.
Read more →UNCY▼ -7.1%on this news
Unicycive Announces Exclusive License and Development Agreement with Lotus for Renazorb in the Republic of Korea Develops Renazorb opportunity in new market for patients with hyperphosphatemia Agreement includes upfront
Unicycive Therapeutics has announced an exclusive license agreement with Lotus Pharmaceutical for the development and commercialization of Renazorb in South Korea. This collaboration aims to address hyperphosphatemia in patients with chronic kidney disease, expanding Renazorb's reach in the Asian market. Unicycive will receive up to $4.45 million in milestone payments, alongside an upfront payment of $750,000. The partnership is positioned to leverage Lotus' established presence in the nephrology market, aiding in Renazorb's development and commercialization.
Read more →UNCY▼ -25.4%on this news
Unicycive Achieves Primary Endpoint in Pivotal Bioequivalence Study of Renazorb Renazorb demonstrates pharmacodynamic bioequivalence to Fosrenol Renazorb's enhanced product profile features reduced pill burden and small,
Achieves Primary Endpoint in Pivotal Bioequivalence Study of Renazorb demonstrates pharmacodynamic bioequivalence to Fosrenol enhanced product profile features reduced pill burden and small, swallowable tablets, which may improve patient compliance track to file New Drug Appli
Read more →UNCY▼ -5.6%on this news
Unicycive Announces Third Quarter Financial Results and Provides Business Update Topline results by year-end as enrollment completed for pivotal bioequivalence study of RENAZORB (lanthanum dioxycarbonate),
Announces Third Quarter Financial Results and Provides Business Update results by year-end as enrollment completed for pivotal bioequivalence study of RENAZORB (lanthanum dioxycarbonate), an investigational phosphate binder for the treatment of hyperphosphatemia in Chronic Kidn
Read more →UNCYUnicycive Announces Second Quarter Financial Results and Provides Business Update Advancing global commercial strategy for Renazorb to treat hyperphosphatemia On track to file regulatory submission to initi
Unicycive Announces Second Quarter Financial Results and Provides Business Update Advancing global commercial strategy for Renazorb to treat hyperphosphatemia On track to file regulatory submission to initiate Phase 1 healthy volunteer study with UNI-494 in second half of 20
Read more →UNCY▲ +9.8%on this news
Unicycive Announces Exclusive License and Development Agreement with Lee's Pharmaceutical Holdings Limited for Renazorb in China and Certain Other Asian Markets Expands and accelerates Renazorb opportunity
Unicycive Announces Exclusive License and Development Lee's Pharmaceutical Holdings Limited for Renazorb in China and Certain Other Asian Markets Expands and accelerates Renazorb opportunity in important markets for patients with hyperphosphatemia through local partner with d
Read more →UNCYUnicycive Announces First Quarter Financial Results and Provides Business Update On track to initiate clinical bioequivalence study of Renazorb to treat hyperphosphatemia in healthy volunteers in second qua
Announces First Quarter Financial Results and Provides Business Update track to initiate clinical bioequivalence study of Renazorb to treat hyperphosphatemia in healthy volunteers in second quarter 2022 to initiate Phase 1 study for UNI-494 in second half of 2022 ALTOS, Calif
Read more →UNCYUnicycive Announces Full Year 2021 Financial Results and Provides Business Update On track to initiate clinical bioequivalence study of Renazorb to treat hyperphosphatemia in healthy volunteers in first hal
Unicycive Announces Full Year 2021 Financial Results and Provides Business Update On track to initiate clinical bioequivalence study of Renazorb to treat hyperphosphatemia in healthy volunteers in first half of 2022 Plans to initiate Phase 1 study for UNI-494 in second half
Read more →UNCY▼ -13.4%on this news· ran to -32% by day 3
Unicycive Therapeutics Receives Confirmatory Guidance on Renazorb Regulatory Pathway On-track to submit New Drug Application in Q4 2022
Therapeutics Receives Confirmatory Guidance on Renazorb Regulatory Pathway On-track to submit New Drug Application in Q4 LOS ALTOS, Calif., November 29, 2021 -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patien
Read more →UNCYUnicycive Therapeutics Announces Third Quarter 2021 Financial Results Expect to receive confirmatory guidance on Renazorb regulatory pathway from the U.S. Food and Drug Administration in Q4 2021
Therapeutics Announces Third Quarter 2021 Financial Results Expect to receive confirmatory guidance on Renazorb regulatory pathway from the U.S. Food and Drug Administration in Q4 2021 LOS ALTOS, Calif., November 11, 2021 -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clin
Read more →UNCYUnicycive Therapeutics Announces Second Quarter 2021 Financial Results Completed initial public offering in July 2021 with gross proceeds of $25 million Planned meeting with the U.S. FDA in Q4 2021 to align on Renazorb p
Therapeutics Announces Second Quarter 2021 Financial Results Completed initial public offering in July 2021 with gross proceeds of $25 million Planned meeting with the U.S. FDA in Q4 2021 to align on Renazorb program LOS ALTOS, Calif., August 16, 2021 -- Unicycive Therapeut
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