we plan to conduct an interim safety analysis of the SOL-R trial in the fourth quarter of 2026 to provide Week 52 safety data on subjects dosed with AXPAXLI in the trial in support of our NDA for AXPAXLI for the treatment of wet AMD.
we anticipate submitting a new drug application, or NDA, to the FDA for marketing approval of AXPAXLI for the treatment of wet AMD during the fourth quarter of 2026.
Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .
Program / event
Stated period and SEC wording
Disclosure in stated period
AXPAXLI (OTX-TKI)Clinical results
fourth quarter of 2026
“we plan to conduct an interim safety analysis of the SOL-R trial in the fourth quarter of 2026 to provide Week 52 safety data on subjects dosed with AXPAXLI in the trial in support of our NDA for AXPAXLI for the treatment of wet AMD.”
“we anticipate submitting a new drug application, or NDA, to the FDA for marketing approval of AXPAXLI for the treatment of wet AMD during the fourth quarter of 2026.”
“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.
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Disclosure date
The date of the filing or company release that disclosed the readout. “None found” means no such disclosure was located in the sources checked. SEC filings were searched through the “SEC filings searched through” date shown.
1H, 2H, 1Q–4Q
First or second half, or first to fourth quarter, of the year named, as the company wrote it. Equivalent notations are compared together; the original wording stays visible.
SEC original
The filing as published on the SEC EDGAR system. “Company original” is the release on the company's own investor site.
Status
One of seven labels set by founder review of the original filings. Definitions: Methodology.
Topline results are the main summary results of a clinical trial, released before the full data.A New Drug Application (NDA) or Biologics License Application (BLA) asks the FDA to approve a drug or biologic for sale.