4D Molecular Reports Promising 60-Week Data From Diabetic Macular Edema Study, Stock Soars

(RTTNews) - Shares of 4D Molecular Therapeutics (FDMT) are up over 26% to $5.69 in premarket trading Friday, following positive 60-week data from its Phase II SPECTRA trial.

The SPECTRA trial is evaluating the company's lead gene therapy candidate, 4D-150, in diabetic macular edema.

DME, or diabetic macular edema, is a complication of diabetic retinopathy and is characterized by inflammation and swelling in the macula due to leakage from blood vessels, which can lead to vision loss.

According to the results announced today, 4D-150 continues to be well tolerated, with no intraocular inflammation reported at any dose level or timepoint. Moreover, the therapy demonstrated durable, dose-dependent efficacy, with sustained improvements in visual acuity and better control over retinal swelling and structure.

The 60-week results build on positive 32-week interim data released in early January.

The company noted that the Phase 3 dose (3E10 vg/eye) achieved a clinically meaningful 78% reduction in treatment burden compared to projections for on-label aflibercept 2mg every 8 weeks (Q8W).

The FDA and EMA have agreed that a single phase III clinical trial, based on data generated to date for 4D-150 in both the SPECTRA and PRISM clinical trials combined with data from the two ongoing Phase 3 clinical trials in the 4FRONT wet age-related macular degeneration (wet AMD) program, would be acceptable as the basis for a marketing authorization application (MAA) submission for 4D-150 in DME.

FDMT has traded in a range of $2.23 to $17.41 in the last 1 year. The stock closed yesterday's trading at $4.50, up 2.04%.