Initiation of Phase 3 registrational study on track by year-end; topline results expected in late 2028; U.S. FDA approval and launch anticipated in 2030
SEC timing context:
XERIS HOSTS WEBINAR DETAILING ITS COMPREHENSIVE DEVELOPMENT PROGRAM FOR XP-8121, AN INVESTIGATIONAL, ONCE-WEEKLY SUBCUTANEOUS LEVOTHYROXINE FOR HYPOTHYROIDISM
Initiation of Phase 3 registrational study on track by year-end; topline results expected in late 2028; U.S. FDA approval and launch anticipated in 2030
SEC timing context:
XERIS HOSTS WEBINAR DETAILING ITS COMPREHENSIVE DEVELOPMENT PROGRAM FOR XP-8121, AN INVESTIGATIONAL, ONCE-WEEKLY SUBCUTANEOUS LEVOTHYROXINE FOR HYPOTHYROIDISM
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
XP-8121Other
by year-end
“Initiation of Phase 3 registrational study on track by year-end; topline results expected in late 2028; U.S. FDA approval and launch anticipated in 2030”
ORION has no confirmed start and end dates for this wording, so it is not compared with filings.
XP-8121Clinical results
in late 2028
“Initiation of Phase 3 registrational study on track by year-end; topline results expected in late 2028; U.S. FDA approval and launch anticipated in 2030”
“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.
Topline results are the main summary results of a clinical trial, released before the full data.A Form 8-K is a report a company files with the SEC to announce a significant event between its regular reports.