Shidlovski
Clinical-stage biotech 4D Molecular (NASDAQ:FDMT) gained on Monday after the company announced data indicating that its gene therapy candidate 4D-150 sharply lowered the rate of anti-VEGF injections such as Eylea in wet age-related macular degeneration (wet AMD).
Developed by Regeneron (REGN) and Bayer (OTCPK:BAYZF) (OTCPK:BAYRY), Eylea, known as aflibercept in generic terms, is approved in the U.S. for multiple eye disorders, including wet AMD.
4D Molecular (FDMT) said its findings were based on interim clinical data from five patients who were part of cohort 1 of the Phase 1/2 clinical trial for intravitreal 4D-150 in wet AMD.
As of Oct. 13, data cut, 4D-150 had led to a ~97% decline in the annualized anti-VEGF injection rate in cohort 1 patients who had a mean annualized anti-VEGF injection rate of ~11 over 12 months before they received the experimental therapy.
Notably, 80% of patients in the group did not receive any aflibercept injections to date, with follow-up periods extending to ~40, 36, 32, or 16 weeks after 4D-150 dosing.
The company said that the investigational therapy was safe and well tolerated, and there were no serious adverse events or dose-limiting toxicities. Full data from the doseeExploration stage of the trial are expected in Q2 2023.
The latest data readout from 4D Molecular (FDMT) has prompted Evercore ISI to raise the price target on the stock to a Street high of $45 from $32 per share, implying a ~260% upside to the last close.
The analyst Josh Schimmer favors 4D-150 as well as 4D-710, for which the company shared Phase 1/2 data in cystic fibrosis lung disease early this month.
