FDMT: Second wAMD Pivotal Completes Enrollment Ahead of Schedule, Topline Data On Track for 1H27

研报英文原文证据摘录

FDMT: Second wAMD Pivotal Completes Enrollment Ahead of Schedule, Topline Data On Track for 1H27

EQUITY RESEARCH QUICK TAKE

RBC Capital Markets, LLC

Lisa Walter, Ph.D. (Analyst)

Luca Issi, Ph.D. (Analyst)

Shelby Hill, Ph.D. (Senior Associate)

Cassie Yuan, Ph.D. (Senior Associate)

June 29, 2026

4D Molecular Therapeutics, Inc.

Second wAMD Pivotal Completes Enrollment Ahead of Schedule, Topline Data On Track

for 1H27

NASDAQ: FDMT | USD 12.88 | Outperform | Speculative Risk | Price Target USD 35.00

Sentiment: Positive

The News: FDMT announced the second of two pivotal studies for wAMD, 4FRONT-2, has completed enrollment ~4 months ahead

of initial projections, and reiterated the first pivotal study 4FRONT-1 remains on track to readout 1H27. The 4FRONT-2 study over-

enrolled with an anticipated N>500 (target enrollment was N=480) and final patient randomization is expected 3Q26. Topline 1-

year data from 4FRONT-2 remains on-track for 2H27. Recall, 4FRONT-2 is a global Phase III study with a primary endpoint of non-

inferiority in the mean change from baseline BCVA (equivalence margin of +/- 4.5 letters) at 52 weeks, enrolling both treatment-

naïve (≥60%) and recently diagnosed, treatment-experienced (up to 40%) patients (previously treated patients must have 1-4

prior injections, diagnosed within 6 months). The study design is a 1:1 randomized, multicenter, double-masked, two-arm study

comparing a single intravitreal dose of 4D-150 gene therapy (3e10 vg/eye) vs 2mg aflibercept Q8W (on-label protocol) over 52

weeks, with patients in both arms eligible for supplemental aflibercept injections. Similar to the 4FRONT-1 study design, 4FRONT-2

patients receive 2 loading doses of aflibercept at baseline (patients must demonstrate a pre-specified level of clinical response