Kardigan, Inc. filed a current report on November 6, 2026, disclosing that it has completed enrollment in its Phase 2b KATALYST-AV trial evaluating ataciguat in people with aortic stenosis.

Key Highlights

  • Enrollment complete: Kardigan announced it had finished enrolling participants in the Phase 2b KATALYST-AV trial of ataciguat in people with aortic stenosis.
  • Primary endpoint: Aortic valve calcium will be the primary endpoint, assessed at week 48, alongside aortic valve area and measures of cardiac structure and function.
  • Topline data timing: According to the filing, topline data from the Phase 2b trial is currently expected in the second half of 2026.
  • Investor webcast: The company disclosed it would host an investor webcast from the American Heart Association Scientific Sessions on Saturday, November 7, 2026, at 8:00 AM ET.
  • Emerging growth company: Kardigan is designated an emerging growth company as defined under applicable securities regulations, according to the filing.

KATALYST-AV Phase 2b Trial: Enrollment Milestone and Key Endpoints

Kardigan, Inc. (NASDAQ:KARD), a clinical-stage company headquartered at 506 Carnegie Center Drive, Suite 201, Princeton, New Jersey, disclosed the completion of enrollment in its Phase 2b KATALYST-AV trial. The trial is evaluating ataciguat, the company's investigational therapy, in people living with aortic stenosis, a condition involving narrowing of the aortic valve that can restrict blood flow from the heart.

According to the filing, the primary endpoint of aortic valve calcium in the KATALYST-AV study will be assessed at the week 48 timepoint. Secondary measures, as stated in the filing, include aortic valve area and measures of cardiac structure and function. The company indicated that topline data from the Phase 2b trial is currently expected in the second half of 2026, though the company's statements regarding timing constitute forward-looking statements subject to its cautionary language.

In connection with the enrollment announcement, Kardigan disclosed it would host an investor webcast from the American Heart Association Scientific Sessions on November 7, 2026, beginning at 8:00 AM ET. The press release associated with the announcement was attached as Exhibit 99.1 and incorporated by reference. The filing notes that the information furnished under Item 7.01, including the press release, is not deemed "filed" for purposes of Section 18 of the Exchange Act and shall not be incorporated by reference into any registration statement or other document pursuant to the Exchange Act.

What Was Disclosed

Kardigan, Inc. disclosed the completion of enrollment in its KATALYST-AV Phase 2b trial of ataciguat for aortic stenosis, identified aortic valve calcium as the primary endpoint at week 48, and announced an investor webcast on November 7, 2026.