Cadrenal Therapeutics, Inc. 8K

Cadrenal Therapeutics obtained FDA alignment on the primary endpoint, statistical plan, and placebo-controlled design for a Phase 3 registrational trial of its HIT drug candidate CAD-1005 following a Type D meeting.

Cadrenal Therapeutics, Inc. announced that it received positive, collaborative feedback from the U.S. Food and Drug Administration in a July 28, 2026 Type D meeting, resulting in regulatory alignment on the primary efficacy endpoint, statistical analysis plan, and use of a placebo-controlled design for its planned Phase 3 registrational study of CAD-1005, a first-in-class 12-LOX inhibitor being developed to treat heparin-induced thrombocytopenia (HIT). The FDA agreed to an optimized definition of worsening HIT based on adjudicated new or worsening thromboembolic events through Day 14 or hospital discharge, including extension of existing thrombi into new vascular segments, and endorsed evaluating bleeding as a major safety endpoint using ISTH criteria. Cadrenal has incorporated the FDA’s recommendations into the Phase 3 protocol and SAP, strengthening the trial design for CAD-1005, which targets a high‑need HIT population of approximately 50,000 U.S. patients annually and is projected by the company to represent a $2 billion peak revenue opportunity, while the company continues to advance its broader cardiovascular pipeline, including tecarfarin and frunexian.

Filing Facts

CIK

1937993

Ticker

-

Form

8K

Source Type

sec

Accession

0001213900-26-095394

Alert Tier

6