Public float: Unknown (no public float found in SEC filings).
Following a positive pre-NDA ("New Drug Application") interaction with the U.S. Food and Drug Administration ("FDA"), we aligned with the agency on the planned content, format and submission strategy for obefazimod’s NDA for adults with moderately to severely active UC. We believe we remain on track to submit our NDA to the U.S. FDA in the fourth quarter of 2026.
Public float: Unknown (no public float found in SEC filings).
Our ENHANCE-CD Phase 2b clinical trial of obefazimod in patients with CD is still ongoing, and the 12-week induction topline data read-out is expected in mid-2027.
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
Obefazimod (ENHANCE-CD)Clinical results
in mid-2027
“Our ENHANCE-CD Phase 2b clinical trial of obefazimod in patients with CD is still ongoing, and the 12-week induction topline data read-out is expected in mid-2027.”
ORION has no confirmed start and end dates for this wording, so it is not compared with filings.
Obefazimod (UC)Submission
in the fourth quarter of 2026
“Following a positive pre-NDA ("New Drug Application") interaction with the U.S. Food and Drug Administration ("FDA"), we aligned with the agency on the planned content, format and submission strategy for obefazimod’s NDA for adults with moderately to severely active UC. We believe we remain on track to submit our NDA to the U.S. FDA in 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.
Related companies
Grouped by stated month; each company’s exact timing wording stays on its own page.
The timing wording in the earliest company statement located within the sources checked, quoted as written (for example “2H 2026”). An earlier statement may exist outside those sources.
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.
A New Drug Application (NDA) or Biologics License Application (BLA) asks the FDA to approve a drug or biologic for sale.Topline results are the main summary results of a clinical trial, released before the full data.