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Unicycive Therapeutics Announces Resubmission of New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease,

3 months ago

#UNCY Unicycive Therapeutics Announces Resubmission of New Drug Application (NDA) for Oxylanthanum Carbonate (OLC)

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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 analysis of OLC data at American Society of Nephrology (ASN) which demonstrates that OLC significantly reduced pill burden in terms of both pill volume (7x) and pill count

4 months ago

#UNCY Unicycive Therapeutics Announces Third Quarter 2025 Financial Results and Provides Business Update

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Unicycive Therapeutics Provides Update from FDA Type A Meeting and Expects to Resubmit OLC NDA Before Year-End Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with

5 months ago

#UNCY Unicycive Therapeutics Provides Update from FDA Type A Meeting and Expects to Resubmit OLC NDA Before Year-End

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Unicycive Therapeutics Shareholders Urged to Connect with Legal Counsel Before October 2025 for Rights Assessment Shareholders of Unicycive Therapeutics are encouraged to reach out to The Gross Law Firm to learn about their rights in relation to potential legal claims before October 14, 2025.

6 months ago

Unicycive Therapeutics Shareholders Urged to Connect with Legal Counsel Before October 2025 for Rights Assessment #USA #New_York #Gross_Law_Firm #Unicycive_Therapeutics #UNCY

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New Patent Until 2040: Unicycive's UNI-494 Drug for Chronic Kidney Disease Gets USPTO Protection Biotech firm Unicycive (UNCY) granted US Patent 12,377,082 for UNI-494 in CKD treatment. Drug has completed Phase 1 trials and holds Orphan Drug status for kidney transplant DGF.

7 months ago

#UNCY Unicycive Therapeutics Granted New U.S. Patent for UNI-494 to Treat Chronic Kidney Disease

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Investor Alert: Examination of Claims Against Unicycive Therapeutics by Pomerantz Law Firm Pomerantz LLP is looking into allegations around Unicycive Therapeutics Inc. regarding possible securities fraud. Investors should take note of this development.

7 months ago

Investor Alert: Examination of Claims Against Unicycive Therapeutics by Pomerantz Law Firm #USA #New_York #Pomerantz_Law_Firm #Unicycive_Therapeutics #UNCY

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7 months ago

Unicycive Posts 65% EPS Gain in Q2 | The Motley Fool

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Unicycive's Kidney Drug Shows 90% Success Rate Despite FDA Hurdle, Reports $22.3M Cash Position Biotech firm requests FDA Type A meeting for kidney drug OLC following manufacturing concerns. Strong efficacy data shows 90% patient response rate. $22.3M cash extends to 2026. Learn more.

7 months ago

#UNCY Unicycive Therapeutics Announces Second Quarter 2025 Financial Results and Provides Business Update

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Pomerantz Law Firm Launches Investigation into Unicycive Therapeutics for Potential Securities Fraud Pomerantz LLP investigates claims for investors of Unicycive Therapeutics, following significant stock price drop after FDA concerns.

8 months ago

Pomerantz Law Firm Launches Investigation into Unicycive Therapeutics for Potential Securities Fraud #United_States #New_York #Pomerantz_LLP #Unicycive_Therapeutics #UNCY

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Pomerantz Law Firm Launches Investigation for Unicycive Therapeutics Investors Amid FDA Response Pomerantz LLP is probing claims for investors of Unicycive Therapeutics, following a significant FDA letter. Discover the implications here.

8 months ago

Pomerantz Law Firm Launches Investigation for Unicycive Therapeutics Investors Amid FDA Response #United_States #New_York #Pomerantz_Law_Firm #Unicycive_Therapeutics #UNCY

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Revolutionary Kidney Disease Drug Shows 90% Success Rate with Just 3 Pills Daily, New Study Reveals New dialysis treatment demonstrates 90% effectiveness in controlling phosphate levels with reduced pill burden. Clinical trial results published in top nephrology journal. See full data.

8 months ago

#UNCY Unicycive Therapeutics Announces the Publication of Oxylanthanum Carbonate Pivotal Trial Data in Clinical Journal of the American Society of Nephrology

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Unicycive Sets 1-for-10 Reverse Split: What This Means for 126M Outstanding Shares Key details on Unicycive's 1-for-10 reverse split effective June 18. Learn how this impacts 126M shares and discover the strategic move for Nasdaq compliance. See full terms.

9 months ago

#UNCY Unicycive Therapeutics, Inc. Announces Reverse Stock Split

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PRISM MarketView

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9 months ago

Unicycive Addresses Manufacturing Issue Ahead of Kidney Drug Decision; Analysts Maintain Buy Rating Unicycive Therapeutics (Nasdaq: UNCY) provided an update on its New Drug Application (NDA) for oxylanthanum carbonate (OLC), its lead candidate for treating hyp

#UNCY updates investors on its NDA for OLC to treat hyperphosphatemia in CKD patients. FDA flagged a third-party vendor issue, but analysts maintain Buy with a $9 PT. June 28 decision still on track.
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FDA Manufacturing Concerns Delay Unicycive's Crucial Kidney Disease Drug Approval Process FDA identifies cGMP compliance issues at third-party vendor for Unicycive's hyperphosphatemia treatment. Final decision expected by June 28. See approval timeline.

9 months ago

#UNCY Unicycive Provides Update on New Drug Application for Oxylanthanum Carbonate to Treat Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

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Unicycive Therapeutics Updates Annual Meeting Schedule: Key Details for Kidney Disease Biotech Investors Unicycive Therapeutics reschedules stockholder meeting time to 7 AM PDT. Location remains unchanged in Los Altos. Check participation details for this kidney disease biotech.

10 months ago

#UNCY Unicycive Therapeutics Announces Time Change for 2025 Annual Meeting of Stockholders

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Unicycive Therapeutics Announces First Quarter 2025 Financial Results and Provides Business Update Unicycive Therapeutics reported its Q1 2025 financial results and provided key business updates. The company's lead product, oxylanthanum carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients on dialysis, has a PDUFA target date of June 28, 2025. Recent patient surveys highlighted adherence challenges with current treatments and demonstrated strong preference for OLC's reduced pill burden. Financial highlights include: R&D expenses decreased to $2.2M from $6.8M YoY, while G&A expenses increased to $5.8M from $2.4M due to commercial launch preparations. The company reported a net income of $0.5M compared to a $21.2M loss in Q1 2024, primarily due to warrant liability changes. Cash position stood at $19.8M as of March 31, 2025.

10 months ago

#UNCY Unicycive Therapeutics Announces First Quarter 2025 Financial Results and Provides Business Update

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FDA to Review Unicycive's Kidney Disease Drug in June 2025: Key Financial Updates Unicycive advances OLC drug for kidney disease with June 2025 FDA decision date. $26.1M cash runway into 2026, Korean partnership milestone potential. Full analysis inside.

1 year ago

#UNCY Unicycive Therapeutics Announces Full Year 2024 Financial Results and Provides Business Update

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51% of Kidney Disease Patients Skip Critical Treatment - New Research Exposes Why Research shows alarming 51% non-adherence rate for phosphate treatments in CKD patients. Study highlights urgent need for better solutions, focusing on pill size and daily burden reduction.

1 year ago

#UNCY Unicycive Therapeutics Announces the Publication of Patient Perspectives on Phosphate Management in the Journal of Nephrological Science

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Unicycive's OLC Drug Shows Strong Safety Profile in Phase 1 Trial, FDA Decision Due 2025 Unicycive Therapeutics reports positive Phase 1 results for oxylanthanum carbonate (OLC), demonstrating safety and effective phosphate binding. FDA decision expected June 2025.

1 year ago

#UNCY Unicycive Therapeutics Announces Publication of Positive Oxylanthanum Carbonate (OLC) Dose Escalation Data in Clinical and Translational Science

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Unicycive's OLC Shows Strong Bioequivalence Data in Kidney Disease Treatment Study, Clinical Therapeutics Reports New clinical data reveals Unicycive's oxylanthanum carbonate matches Fosrenol's effectiveness in treating hyperphosphatemia, with positive safety profile and 2025 launch planned.

1 year ago

#UNCY Unicycive Therapeutics Announces Publication of Oxylanthanum Carbonate (OLC) Positive Bioequivalence Data in Clinical Therapeutics

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1 year ago

#UNCY Unicycive Therapeutics to Participate in Two Upcoming Investor Conferences Including a Fireside Chat at the Piper Sandler 36th Annual Healthcare Conference

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1 year ago

News; ( NASDAQ: #UNCY ) 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

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1 year ago

Breaking News: ( NASDAQ: #UNCY ) Unicycive Therapeutics Announces Late-Breaker Poster Presentation on Oxylanthanum Carbonate (OLC) at the American Society of Nephrology (ASN) Kidney Week 2024

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1 year ago

Just In: ( NASDAQ: #UNCY ) Unicycive Therapeutics to Participate in a Fireside Chat at the Virtual Lytham Partners Fall 2024 Investor Conference on October 1, 2024

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1 year ago

Breaking News: ( NASDAQ: #UNCY ) Life Sciences Virtual Investor Forum Presentations Now Available for Online Viewing

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1 year ago

News; ( NASDAQ: #UNCY ) Unicycive Therapeutics to Present at the H.C. Wainwright 26th Annual Global Investment Conference

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1 year ago

NEWS: ( NASDAQ: #UNCY ) Unicycive Announces Second Quarter 2024 Financial Results and Provides Business Update

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