Following positive results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 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
aficamtenSubmission
Q4 2026
“Following positive results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 2026.”
The stated period has not started yet, so there is nothing to compare.
aficamtenSubmission
Q4 2026
“Following positive topline results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 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
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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.
A PDUFA date is the target date by which the FDA aims to decide on a drug or biologic application.A New Drug Application (NDA) or Biologics License Application (BLA) asks the FDA to approve a drug or biologic for sale.Q1–Q4 (also written 1Q–4Q) are quarters of the year: Q1 is January–March, Q2 April–June, Q3 July–September and Q4 October–December, unless the company uses a different fiscal year.