Highest-materiality recent filing
Unicycive raises ATM capacity to $150M; files new $50M shelf registration
Entered Amendment No. 2 to Sales Agreement with Guggenheim Securities on June 5, 2026.
Unicycive Q1 2026 net loss $12.8M; OLC PDUFA target June 29, 2026
Net loss of $12.8M ($0.54 per share basic/diluted) vs net income of $0.5M in Q1 2025.
Unicycive Therapeutics FY2025 net loss $26.6M ($1.67/sh); OLC PDUFA date June 29, 2026
Net loss attributable to common holders: $26.6M ($1.67/sh) vs $37.8M ($5.65/sh) in FY2024.
Unicycive Q3 net loss $6.0M, cash $42.7M; plans OLC NDA resubmission by year-end 2025
Net loss of $6.0M for Q3 2025 vs $4.1M in Q3 2024; cash $42.7M as of Sept 30, 2025, with runway into 2027.
Unicycive expects to resubmit OLC NDA by year-end after constructive FDA Type A meeting; cash $42M
Cash and cash equivalents ~$42M as of Sept 30, 2025; runway into 2027 supports NDA resubmission, potential FDA approval, and launch.
Unicycive discloses securities class action over phosphate binder NDA statements
Lawsuit filed in U.S. District Court for Northern District of California against company and certain officers.
Unicycive sells 3.55M shares for ~$16.3M net via ATM offering
Sold 3,549,846 shares at average $4.56 per share since June 30, 2025.
Unicycive Q2 net loss $6.4M; requests FDA Type A meeting for CRL on OLC
Net loss of $6.4M vs net income of $3.0M in Q2 2024; R&D expenses down to $1.8M.
Unicycive regains Nasdaq minimum bid price compliance after reverse split
Regained compliance with Nasdaq minimum bid price of $1.00 per share.
CRL cites deficiencies at third-party manufacturing vendor unrelated to OLC drug; no clinical or safety concerns.
Unicycive Therapeutics effects 1-for-10 reverse stock split to regain Nasdaq compliance
Reverse stock split at 1-for-10 ratio effective June 18, 2025; begins trading split-adjusted June 20, 2025.
Unicycive FDA update: cGMP deficiencies at OLC manufacturing subcontractor; PDUFA June 28
FDA identified cGMP deficiencies at a third-party manufacturing subcontractor (not drug substance vendor) for oxylanthanum carbonate.
Unicycive reports Q1 net income $0.5M, cash $19.8M, OLC PDUFA June 28, 2025
Net income attributable to common stockholders of $0.5M for Q1 2025, vs net loss of $21.2M in Q1 2024.
Unicycive reports FY 2024 net loss of $37.8M; OLC NDA under FDA review with PDUFA June 28, 2025
Net loss attributable to common stockholders $37.8M or $0.56 per share, vs $31.4M ($1.28) in 2023.
Unicycive Q3 net loss $4.1M; OLC NDA accepted with PDUFA June 2025
Net loss $4.1M vs $4.4M YoY; cash $32.3M expected to fund into 2026.
FDA accepts Unicycive's NDA for Oxylanthanum Carbonate; PDUFA date June 28, 2025
FDA accepted NDA for OLC to treat hyperphosphatemia in CKD patients on dialysis.
Unicycive Q2 net income $3.0M; OLC NDA on track for August 2024
OLC pivotal trial: 1.4% discontinuation rate (evaluable) for treatment-related AEs; no SAEs.
Unicycive Therapeutics receives Nasdaq bid price deficiency notice; 180 days to regain compliance
Received Nasdaq notice on July 9, 2024 for bid price below $1.00 for 30 consecutive business days.
Unicycive receives Nasdaq deficiency notices for bid price and market value
On July 9, 2024, Nasdaq notified Unicycive that stock bid price closed below $1.00 for 30 consecutive days, violating Listing Rule 5550(a)(2).
Unicycive Therapeutics doubles authorized common stock to 400M shares
Stockholders approved increase from 200M to 400M shares on June 20, 2024.
Unicycive OLC pivotal trial meets primary endpoint; NDA submission planned Q3 2024
Primary endpoint achieved: only 1.4% treatment-related discontinuation in evaluable population (n=71), vs 14% for Fosrenol.
Unicycive Q1 net loss $21.2M ($0.61/sh); OLC pivotal topline due Q2 2024
Net loss $21.2M ($0.61/sh) vs $14.8M ($0.97) in Q1 2023; R&D expenses rose to $6.8M from $3.0M.
Unicycive reports FY2023 net loss of $31.4M; OLC topline data expected Q2 2024
FY2023 net loss $31.4M ($1.28/share) vs $18.1M ($1.20/share) in FY2022.
Unicycive raises $50M in private placement of Series B Convertible Preferred Stock
$50M gross proceeds from sale of 50,000 Series B shares at $1,000 each; close expected March 18, 2024.
Unicycive regains compliance with Nasdaq minimum market value and bid price rules
On Feb 21, 2024, Nasdaq notified Unicycive that it regained compliance with the $35M minimum market value and $1.00 minimum bid price requirements.
Unicycive reports Q3 net loss of $4.4M; FDA alignment on OLC NDA path
Net loss $4.4M ($0.13/share) vs $5.6M ($0.37/share) in Q3 2022; R&D expenses $3.4M, down from $4.8M.
Unicycive reaches FDA alignment on NDA path for OLC; pivotal trial to start by end of 2023
FDA agreed on full NDA package requirements: clinical, preclinical, and CMC data for Oxylanthanum Carbonate (OLC).
Unicycive receives Nasdaq deficiency notices for market value <$35M and bid price <$1.00
On Sept 19, 2023, Nasdaq notified UNCY its market value of common stock was below $35M minimum for 30 consecutive business days.
Unicycive Q2 net loss $4.4M; OLC FDA feedback expected Fall 2023; UNI-494 Phase 1 ongoing
Net loss of $4.4M ($0.29/share) in Q2 2023, up from $3.6M ($0.24) in Q2 2022 due to higher R&D and G&A costs.
Auditor Mayer Hoffman McCann resigns as Unicycive's independent auditor
Auditor MHM resigned effective upon earlier of new auditor engagement, filing of June 2023 Form 10-Q, or Aug 20, 2023.
Unicycive receives FDA request for additional data on LDC NDA; timeline extended
FDA asked for risk assessment and clinical data to evaluate tolerability of lanthanum dioxycarbonate in dialysis patients.
Unicycive receives Nasdaq notice for failure to meet $35M market value requirement
Nasdaq notified Unicycive on May 17, 2023 that common stock MV fell below $35M for 30 consecutive business days.
Unicycive Q1 net loss $14.6M ($0.97/sh) vs $3.5M loss YoY; cash $24.3M from $30M upfront financing
Net loss of $14.6M ($0.97/sh) compared to $3.5M ($0.24/sh) in Q1 2022; includes $10.4M change in warrant liability.
Net loss for 2022 was $18.1M ($1.20/sh) vs $10.0M ($0.86/sh) in 2021.
On September 5, 2023, Unicycive Therapeutics, Inc. (the “Company”) appointed Sara Kenkare-Mitra as an independent director.
effective as of the closing of the Offering, Gaurav Aggarwal, MD shall be appointed to the Company’s Board of Directors.
Max materiality 0.85 · Median 0.65 · Most common event other_material