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Unicycive Therapeutics

UNCY Lead: NDA Submitted 5 Biotech Distilled articles ↓ 23 filings & releases ↓ Cash $44.2M (Jun 30, 2026) ↓ 5 verdicts ↓
Renal Small Molecule

Market cap $98.9M 27.9M shares (10-Q, Aug 12, 2026) × $3.55 close Nov 6, 2026

Most recent annual filing: 2026-03-30

Catalyst timeline

1 trackedQuarter catalyst calendar →
  1. UNCY TDAPA corporate updateDec 31, 2026UNCY TDAPA corporate update, Dec 31, 2026, routine

Bar width shows how precise the guidance is — a pin is a stated date, a wide band a six-month window. Deeper blue means more of the thesis rides on the event; it is not a view on the stock.

Pipeline (2 active programs)

Capital (as filed)

Cash
$44.2M cash and cash equivalents · Jun 30, 2026 (10-Q)
Short-term investments
$17.2M Jun 30, 2026
Operating cash flow
−$7.6M quarter Mar 31, 2026 → Jun 30, 2026, year-to-date difference (10-Q)
As stated in coverage
$61.4M cash, runway into 2H 2027 per the update of Sep 29, 2026 — the company's own words as read there, not the filed figure

Cash, investments and operating cash flow are the company's own XBRL facts as filed with the SEC, each shown with its period end and tag. As-stated figures come from the company's own words as read in Biotech Distilled coverage, dated, and routinely count securities and planned financing that a balance sheet does not. Offering rows are the SEC cover pages as filed. Not investment advice. Figures as of Nov 7, 2026.

Biotech Distilled coverage (5)

Articles open on Substack. Some are subscriber-only; those marked ★ Distilled Pro are for Distilled Pro members.

Verdict history (5 calls)

Every verdict Biotech Distilled has published on Unicycive Therapeutics, oldest first — the full history, never a selection. How calls are scored: the track record.

  1. 2026-06-26 Watch Unicycive Therapeutics (UNCY) - Scientific Deep Dive for Oxylanthanum Carbonate (OLC) and Pipeline Products OLC is a legitimate, approvable reformulation but buying common four days before a manufacturing-driven PDUFA at a 52-week high with heavy dilution and an unresolved CMS TDAPA thesis is poor risk/reward; revisit after the binary resolves.
  2. 2026-07-24 Avoid UPDATE: Unicycive Therapeutics (UNCY) — The Same CRL, Twice A second CRL on the same manufacturing deficiency with the FDA never having inspected the site, combined with a shrinking TDAPA window and post-approval financing now coming from a position of weakness, makes the equity uninvestable.
  3. 2026-08-13 Avoid UPDATE: Unicycive Therapeutics (UNCY) - The Inspection Finally Got Assigned An assigned FDA inspection converts the gating item from unschedulable to dated and binary, but the vendor has failed to clear cGMP across two review cycles, dilution is accelerating, and the TDAPA window keeps shrinking — the inspection result, not the assignment, is the event worth waiting for.
  4. 2026-09-29 Watch UPDATE: Unicycive Therapeutics (UNCY) - They Stopped Waiting for the Factory Resubmission with a new NAI-rated vendor and a dated PDUFA around late March 2027 removes the main reason for AVOID, but the TDAPA window closes before any realistic approval and ATM dilution continues, so a new position looks early.
  5. 2026-10-22 Watch UPDATE: Unicycive Therapeutics (UNCY) - The Clock Is Set: March 25, 2027 FDA acceptance as Class II with a March 25, 2027 PDUFA confirms the timeline, but an unresolved possible pre-approval inspection of the new site, unconfirmed TDAPA eligibility, and ongoing ATM dilution keep the stance at Watch List.

Every verdict Biotech Distilled has published on this company, in order, with the post it came from — the full history, never a selection. Position figures are the same ones shown on /track-record, computed by the same method. Editorial opinion, not investment advice.

Filings & releases (23)

SEC filings from EDGAR and press releases captured from the company's investor-relations site, newest first. Releases captured from Jun 30, 2026; filings from March 2026. Summaries come from the BD update that read the document; "BD extracted" counts point at the pipeline table above. All companies →

10 more filings (13G holder notices, S-8, proxy material, SEC correspondence …)