Complement Therapeutics Announces FDA Fast Track Designation for CTx001 for the Treatment of Geographic Atrophy Secondary to AMD - PressReach

Complement Therapeutics Announces FDA Fast Track Designation for CTx001 for the Treatment of Geographic Atrophy Secondary to AMD - PressReach

FDA Fast Track designation has been granted to CTx001 for Geographic Atrophy secondary to Age-related Macular Degeneration CTx001 is an investigational AAV-based gene therapy designed to modulate multiple pathways of the complement system CTx001 has previously received FDA IND clearance and will be evaluated in Opti-GAIN, a first-in-human Phase I/II clinical trial MUNICH, Jan. 8, 2026 /PRNewswire/ — Complement Therapeutics GmbH (CTx), a clinical…

Complement Therapeutics’ Lead Gene Therapy Receives FDA Fast Track Designation for GA

Complement Therapeutics announced that the FDA has granted Fast Track Designation for CTx001, the company’s lead gene therapy candidate for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The designation follows the FDA’s clearance of the investigational new drug (IND) application for CTx001, allowing the program to advance into clinical development. Fast Track Designation is intended to facilitate t…

Complement Therapeutics Announces FDA Fast Track Designation for CTx001 for the Treatment of Geographic Atrophy Secondary to AMD – Complement Therapeutics

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