November 2024 – Insignis Therapeutics, Inc

FDA feedback confirms clear pathway to approval for IN-001
Key trial focus: PK/PD in healthy subjects, with PK bracketed by standard epinephrine injections
No placebo-controlled efficacy studies required

NORTH HAVEN, Conn., Nov. 05, 2024 (GLOBE NEWSWIRE) — Insignis Therapeutics, a leader in innovative allergy and anaphylaxis treatments, announced today that it has received positive feedback from the U.S. Food and Drug Administration (FDA) with regard to its clinical development program for IN-001, a needle free epinephrine sublingual spray designed for the emergency treatment of anaphylaxis. IN-001 is based on an FDA-approved epinephrine prodrug that enhances stability and absorption.

Continue reading “Insignis Therapeutics Receives Positive FDA Feedback on IN-001 Clinical Program for Needle-Free Anaphylaxis Treatment”