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November 05, 2024 08:00 ET | Source: Insignis Therapeutics, Inc.

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

Insignis Therapeutics advances IN-001, a needle-free anaphylaxis treatment, following FDA’s positive feedback and Fast Track designation.
October 07, 2024 08:00 ET | Source: Insignis Therapeutics, Inc.

Insignis Therapeutics Announces Positive Results from Phase 1 Clinical Study of IN-001 Liquid Epinephrine Sublingual Spray for Anaphylaxis

Insignis' Phase 1 trial shows IN-001 spray quickly reaches target epinephrine levels, sustained for 2 hours, offering a reliable needle-free alternative.
August 13, 2024 07:30 ET | Source: Insignis Therapeutics, Inc.

Insignis Therapeutics Receives FDA Fast Track Designation for IN-001 for Anaphylaxis Treatment

Insignis’ liquid epinephrine sublingual spray for anaphylaxis, stable and usable under both extreme heat and cold, gains FDA Fast Track designation.
October 29, 2020 07:30 ET | Source: Insignis Therapeutics, Inc.

Insignis Therapeutics and HLK Pharmacin Receive FDA IND Clearance to Initiate a Phase 1 Trial With IN-001 for Oral Anaphylaxis Treatment

Trial to initiate this quarter with data anticipated in 2021 Convenient oral alternative to injectable epinephrine NORTH HAVEN, Conn. and NEW HAVEN, Conn., Oct. 29, 2020 (GLOBE NEWSWIRE) --...