Monitor for the actual IND submission in Q4 2026 and any FDA feedback (clinical hold or clearance). The NDA timeline of ~1 year is contingent on funding and trial completion — watch for capital raises or partnership announcements to fund the XRX-OXY-102 trial.
Price Chart
Executive Summary
XORTX Therapeutics announced plans to submit an IND to the FDA in Q4 2026 for its XRx-026 gout program (XORLO formulation of oxypurinol), targeting an NDA submission in approximately one year. The press release contains no financial results, guidance, or operational data — it is a clinical-stage pipeline update with no revenue or earnings to report.
Key Facts
- Planned IND submission to FDA for XRx-026 (XORLO) in Q4 2026
- Targeting NDA submission in approximately one year, subject to funding and trial completion
- XRx-026 addresses an estimated US$700M per annum market opportunity based on prior febuxostat peak sales
- No financial results, revenue, EPS, or guidance reported in this press release
Financial Impact
No financial data reported; clinical-stage company with no revenue. Market opportunity estimated at $700M per annum for XRx-026 program.
Risk Factors
- IND submission may be delayed or placed on clinical hold by FDA
- XRX-OXY-102 trial may not yield positive results or support NDA filing
- Company requires additional capital to fund development — risk of dilutive financing
- Competition from existing gout therapies (allopurinol, febuxostat) with established market presence
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3364673 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 8, 2026 17d ago | 6-K | $1.41 | awaiting T+20 | — | $1.07 (−24.11%) |
Sep 18, 2026 5w ago | 6-K | $1.92 $1.24 | ▼ −35.42% | ▼ −35.62% | $1.07 (−44.27%) |
Sep 18, 2026 5w ago | Press Release | $1.92 $1.24 | ▼ −35.42% | ▼ −35.62% | $1.07 (−44.27%) |
Sep 4, 2026 7w ago | 6-K | $2.31 $1.70 | ▲ +26.41% | ▲ +27.01% | $1.07 (+53.68%) |
Aug 28, 2026 8w ago | 6-K | $2.34 $1.71 | ▼ −26.86% | ▼ −27.12% | $1.07 (−54.23%) |
Aug 3, 2026 11w ago | 6-K | $2.16 $2.16 | · 0.00% | ▲ +1.24% | $1.07 (−50.46%) |
Jul 29, 2026 12w ago | 6-K | $2.06 $2.22 | ▲ +7.67% | ▲ +2.65% | $1.07 (−48.06%) |
Jun 15, 2026 19w ago | 6-K | $2.19 $2.03 | ▼ −7.31% | ▼ −6.56% | $1.07 (−51.14%) |
Jun 12, 2026 19w ago | 6-K | $2.19 $2.03 | ▼ −7.31% | ▼ −6.56% | $1.07 (−51.14%) |
May 19, 2026 22w ago | 6-K / PRESS-RELEASE | $2.32 $2.15 | ▲ +7.33% | ▲ +8.31% | $1.07 (+53.88%) |
US Market Status
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