02:32 PM EDT, 03/28/2024 (MT Newswires) -- 4D Molecular Therapeutics ( FDMT ) said it conducted initial pivotal study interactions with the US Food and Drug Administration and European Medicines Agency over its development plans for 4D-710 for treatment of cystic fibrosis lung disease.
"We are encouraged by our productive interactions with the FDA and EMA," said CEO David Kirn. "We are committed to advancing 4D-710 into pivotal trial development efficiently, while maintaining our current focus on initiation and completion of two Phase 3 wet AMD studies with 4D-150."
Kirn said the goal is to initiate phase 3 development in H2 2025 with 4D-710 suspension GMP process clinical trial material.
Shares of 4D Molecular were down more than 12% in recent Thursday trading.
Price: 31.31, Change: -4.56, Percent Change: -12.71