4DMT Completes Enrollment for 4FRONT-1 Phase 3 Clinical Trial of 4D-150 in Wet AMD

Rhea-AI Summary

4D Molecular Therapeutics (Nasdaq: FDMT) announced completion of enrollment for 4FRONT-1, the first Phase 3 registrational trial of 4D-150 in wet age-related macular degeneration (wet AMD), achieved in approximately 11 months and with over-enrollment expected to exceed 500 randomized patients.

Topline primary endpoint data for 4FRONT-1 is expected in H1 2027; global activation for 4FRONT-2 continues with enrollment on track for completion in H2 2026 and topline data expected in H2 2027.

Positive

• Enrollment completed in approximately 11 months
• Study over-enrolled and is expected to exceed 500 randomized patients
• Topline primary endpoint data for 4FRONT-1 expected in H1 2027
• 4FRONT-2 global enrollment on track to complete in H2 2026 with topline in H2 2027

Negative

• Study design allows supplemental aflibercept for both arms, which could complicate measuring treatment-burden reduction
• Primary endpoint is a non-inferiority comparison at 52 weeks, requiring robust outcomes to demonstrate parity

News Market Reaction – FDMT

+1.00%

1 alert

+1.00% News Effect

On the day this news was published, FDMT gained 1.00%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

4FRONT-1 enrollment period: 11 months 4FRONT-1 enrollment size: Over 500 patients Primary endpoint duration: 52 weeks +5 more

8 metrics

4FRONT-1 enrollment period 11 months Time to complete enrollment for Phase 3 4D-150 wet AMD trial

4FRONT-1 enrollment size Over 500 patients Randomized in first registrational Phase 3 4D-150 wet AMD trial

Primary endpoint duration 52 weeks Change in best corrected visual acuity (BCVA) in 4FRONT-1

Comparator dose 2 mg aflibercept Q8W comparator regimen in 4FRONT-1 Phase 3 study

Time since first 4D-150 patient 4 years From first wet AMD treatment to 4FRONT-1 full enrollment

4FRONT-1 topline timing H1 2027 Expected topline primary endpoint data for 4FRONT-1

4FRONT-2 enrollment completion H2 2026 Target for completing global enrollment in 4FRONT-2

4FRONT-2 topline timing H2 2027 Expected topline primary endpoint data for 4FRONT-2

Market Reality Check

Price: $9.33 Vol: Volume 778,173 is roughly...

normal vol

$9.33 Last Close

Volume Volume 778,173 is roughly in line with 20-day average of 785,560, indicating typical trading activity into this news. normal

Technical Price $8.99 is trading above the 200-day MA at $7.05, reflecting a pre-existing upward trend.

Peers on Argus

FDMT gained 7.15% while peers were mixed: LRMR and TECX rose, OCGN declined, and...

FDMT gained 7.15% while peers were mixed: LRMR and TECX rose, OCGN declined, and MBX/DSGN saw smaller moves. This points to a company-specific reaction to the 4FRONT-1 enrollment milestone rather than a broad biotech move.

Previous Clinical trial Reports

5 past events · Latest: Dec 17 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 17	CF trial update	Positive	-20.1%	Positive interim Phase 1 AEROW data for 4D-710 in cystic fibrosis lung disease.
Nov 06	Wet AMD data	Positive	+3.9%	Long-term PRISM Phase 1/2 data for 4D-150 in wet AMD showing durable benefit.
Oct 13	CF funding & trial	Positive	+8.7%	Additional CF Foundation funding and advancement of 4D-710 into Phase 2.
Jul 31	DME trial data	Positive	+42.7%	Positive 60-week SPECTRA results for 4D-150 in DME with reduced treatment burden.
Jul 02	Wet AMD program	Positive	-1.6%	Acceleration of 4D-150 Phase 3 wet AMD program and organizational streamlining.

Pattern Detected

Clinical news often positive, but reactions vary with some sharp divergences.

Recent Company History

Over the past several months, FDMT has repeatedly reported clinical progress across ophthalmology and cystic fibrosis. Prior wet AMD and DME updates for 4D-150, including PRISM and SPECTRA data, highlighted durable efficacy and treatment-burden reductions, sometimes driving strong gains (e.g., a 42.67% move on DME data) but also occasional selloffs, such as a -20.05% reaction to positive 4D-710 data. Today’s completion of 4FRONT-1 Phase 3 enrollment fits this pattern of advancing late-stage programs in retinal disease.

Historical Comparison

+6.7% avg move · Past clinical-trial headlines for FDMT moved the stock by an average of 6.71%. Today’s 7.15% reactio...

clinical trial

+6.7%

Average Historical Move clinical trial

Past clinical-trial headlines for FDMT moved the stock by an average of 6.71%. Today’s 7.15% reaction to Phase 3 enrollment completion is broadly in line with those prior responses.

Clinical updates have moved from early positive data in DME and cystic fibrosis toward late-stage wet AMD execution, culminating in full Phase 3 4FRONT-1 enrollment and setting up multiple Phase 3 readouts in 2027.

Market Pulse Summary

This announcement underscores continued execution in FDMT’s late-stage wet AMD program, with 4FRONT-...

Analysis

This announcement underscores continued execution in FDMT’s late-stage wet AMD program, with 4FRONT-1 fully enrolled and topline data expected in H1 2027. It builds on prior positive DME and wet AMD data that sometimes produced large moves. Investors may track progress of 4FRONT-2 enrollment through H2 2026, future data readouts across the pipeline, and overall cash usage and dilution risk when evaluating the company’s trajectory.

Key Terms

wet amd, phase 3, intravitreal injection, best corrected visual acuity (bcva), +4 more

8 terms

wet amd medical

"4D-150 in patients with wet age-related macular degeneration (wet AMD)."

Wet AMD (wet age-related macular degeneration) is an eye disease in older adults where abnormal, leaky blood vessels grow under the retina and cause rapid vision loss in the center of the visual field. It matters to investors because it creates a sustained market for treatments, diagnostics and devices: changes in diagnosis rates, new drugs, or reimbursement rules can quickly affect healthcare revenues and the valuation of companies working on therapies.

phase 3 medical

"the first Phase 3 clinical trial evaluating 4D-150 in patients with wet age-related"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

intravitreal injection medical

"a single in-office intravitreal injection providing sustained disease control."

An intravitreal injection is a medical procedure that delivers medicine directly into the gel-like center of the eye to reach the retina at the back of the eye, much like putting a targeted dose into a small reservoir. It matters to investors because this delivery method affects how often patients need treatment, the complexity and cost of care, reimbursement decisions, and the commercial prospects and safety profile of eye drugs being developed or sold.

best corrected visual acuity (bcva) medical

"mean change from baseline in best corrected visual acuity (BCVA) at 52 weeks."

Best corrected visual acuity (BCVA) measures how clearly a person can see when wearing their optimal glasses or contact lenses, typically tested by reading letters on an eye chart. Investors care because BCVA is a common clinical-trial endpoint and regulatory benchmark for eye treatments and devices—improvements indicate real patient benefit and can drive product approval, market adoption, and revenue potential, much like a performance score that validates a new tool.

randomized, double-masked medical

"a Phase 3 multicenter, randomized, double-masked, aflibercept 2 mg (Q8W)"

A clinical study design where participants are assigned to treatment groups by chance (randomized) and neither the participants nor the investigators know who receives which treatment (double-masked). Think of it as flipping a coin to assign treatments and keeping the envelopes sealed so expectations don’t influence outcomes; this reduces bias and makes results more trustworthy, which matters to investors because more reliable trials lower scientific and regulatory risk and can affect a drug or product’s market prospects.

aflibercept medical

"double-masked, aflibercept 2 mg (Q8W) comparator-controlled study of intravitreal 4D-150"

Aflibercept is a lab-made protein drug that blocks the signals that tell the body to grow new blood vessels; it is used as an injected treatment for certain eye diseases that cause vision loss and in some cancer therapies to slow tumor blood supply. Investors care because its sales, patent protection, regulatory approvals, and competition directly affect a drugmaker’s revenue stream and future growth prospects, much like a key product line in any business.

treatment-naïve medical

"The 4D-150 4FRONT-1 Phase 3 trial enrolled in 11 months in a treatment-naïve"

Patients described as treatment-naïve have not previously received the therapy being studied or other prior treatments for the same condition, so their bodies are ‘untouched’ by those drugs. For investors, this matters because results in a treatment-naïve group show how a therapy performs without prior drug effects, influence trial design and regulatory labeling, and help estimate the size and profile of the initial market—like testing a new seed in a garden that has never been treated before.

topline data technical

"Topline data from 4FRONT-1 expected in H1 2027"

Topline data are the initial, high-level results from a clinical study that show whether the main goals of the trial were met, much like the headline of a news story that summarizes the most important point. Investors care because these early outcomes quickly indicate a drug’s commercial potential and regulatory path — positive topline results can boost a company’s value, while disappointing ones can sharply reduce expected future revenue.

AI-generated analysis. Not financial advice.

• Enrollment for 4FRONT-1, the first registrational trial for 4D-150 in wet AMD, was completed within an approximately 11-month period, ahead of initial projections 
• 4FRONT-1 overenrolled and expected to exceed 500 patients randomized, reflecting strong interest from investigators and patients
• Topline data from 4FRONT-1 expected in H1 2027
• 4FRONT-2 global site activation momentum continues, with enrollment completion on track for H2 2026 and topline data expected in H2 2027

EMERYVILLE, Calif., Feb. 09, 2026 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT, or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced enrollment completion for 4FRONT-1, the first Phase 3 clinical trial evaluating 4D-150 in patients with wet age-related macular degeneration (wet AMD).

“The 4D-150 4FRONT-1 Phase 3 trial enrolled in 11 months in a treatment-naïve large market patient population. This is a landmark moment for 4DMT, for wet AMD patients and for our targeted and locally delivered genetic medicines,” said David Kirn, M.D., Co-founder, President, and Chief Executive Officer of 4DMT. “This high enrollment rate and over-enrollment in the front-line wet AMD setting reflects investigator and patient enthusiasm for 4D-150 as a potential backbone therapy. Remarkably, our team achieved this milestone in only four years after treating the first patient with 4D-150 in wet AMD. I want to extend my heartfelt congratulations to the entire 4DMT team for their tireless work, dedication, and execution in reaching this achievement. We look forward to continuing this momentum as we accelerate global enrollment in our second Phase 3 study, 4FRONT-2.”

“For far too long, wet AMD patients have faced the burden of relentless, lifelong repeated bolus injections and vision loss,” said Julie Clark, M.D., Chief Medical Officer of 4DMT. “Our vision is to fundamentally shift that paradigm, to bring forward a potential backbone therapy that meaningfully reduces treatment burden while sustaining vision outcomes. The rapid enrollment completion, driven by the enthusiasm for 4D-150 and data generated to date, energizes our entire organization as we work relentlessly toward completing global enrollment in 4FRONT-2 and prepare for topline data in H1 2027 from 4FRONT-1. I want to thank all our sites, study coordinators, and patients for their partnership and trust as we work toward our goal to drive a new standard of care for wet AMD.”

“As retina specialists, we routinely observe the challenges long-term intravitreal injection regimens pose for wet AMD patients and their association with suboptimal long-term vision outcomes in real-world practice,” said Arshad M. Khanani, M.D., M.A., FASRS, Director of Clinical Research at Sierra Eye Associates, Chair of the 4DMT Ophthalmology Advisory Board and a principal investigator in the 4FRONT-1 clinical trial. “Based on the long-term PRISM Phase 1/2 data, 4D-150 has the potential to significantly reduce treatment burden for patients with wet AMD, with a single in-office intravitreal injection providing sustained disease control. The rapid enrollment of 4FRONT-1 in treatment-naïve patients is particularly encouraging and reflects strong enthusiasm among physicians and patients for therapies that offer potentially safe, effective, and durable long-term disease control. This progress is also a testament to the strong execution and deep expertise of the 4DMT team in advancing Phase 3 clinical trials. I look forward to the continued advancement of the 4FRONT registrational program.”

4FRONT-1 is a Phase 3 multicenter, randomized, double-masked, aflibercept 2 mg (Q8W) comparator-controlled study of intravitreal 4D-150 in wet AMD. The primary endpoint is non-inferiority in the mean change from baseline in best corrected visual acuity (BCVA) at 52 weeks. The key secondary endpoint is treatment burden reduction comparing the number of aflibercept injections received in the 4D-150 arm versus the aflibercept comparator arm over 52 weeks. Patients in both arms will be eligible for supplemental aflibercept injections. 4FRONT-1 is evaluating treatment-naïve wet AMD patients at sites in North America. Topline primary endpoint data from 4FRONT-1 is expected in H1 2027. Our second Phase 3 for wet AMD, 4FRONT-2, is a global trial with an identical design to 4FRONT-1 except for enrolling both treatment-naïve and recently diagnosed treatment-experienced wet AMD patients. 4FRONT-2 is expected to complete enrollment in H2 2026 with topline primary endpoint data expected in H2 2027.

About 4D-150

4D-150 is a potential backbone therapy designed to provide multi-year, and potentially lifelong, sustained delivery of anti-VEGF biologics (aflibercept and anti-VEGF-C) within the retina following a single, safe, intravitreal injection. 4D-150 utilizes our customized and evolved intravitreal AAV vector, R100, which was invented at 4DMT through our proprietary Therapeutic Vector Evolution platform. 4D-150 is being developed for wet AMD and diabetic macular edema (DME), which both affect millions of patients globally, with the goal of freeing patients from burdensome injections while preserving vision.

About Wet AMD

Wet AMD, or wet age-related macular degeneration, is a highly prevalent disease, with more than 4 million individuals expected to be affected in the next five years in certain major markets, including the U.S., the EU and Japan. The disease also has a high incidence, with 200,000 individuals estimated to be newly diagnosed every year in the U.S. alone. Wet AMD is a type of macular degeneration in which abnormal blood vessels grow into the macula (macular neovascularization or MNV), the central area of the retina. MNV causes swelling and edema of the retina, bleeding and scarring, leading to visual distortion and reduced visual acuity. The proliferation and leakage of abnormal blood vessels is stimulated by VEGF. This process distorts and, without treatment, can potentially destroy central vision and may progress to blindness.

About 4DMT  

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients with retina diseases. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF biologics (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and the second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT.  

All of the Company’s product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. No representation is made as to the safety or effectiveness of the Company’s product candidates for the therapeutic uses for which they are being studied. 

Learn more at www.4DMT.com and follow us on LinkedIn. 

Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the therapeutic potential and clinical benefits of, as well as the plans, announcements and related timing for the clinical development, regulatory interactions, and potential commercialization of our product candidates, including 4D-150. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target,” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including: (i) risks that clinical trial results may not support regulatory approval or demonstrate sustained therapeutic benefit; (ii) risks that our product candidates may not demonstrate sufficient safety or efficacy; (iii) risks related to regulatory approval processes and evolving standards for gene therapies; (iv) risks that 4D Molecular Therapeutics may not receive necessary funding or may require additional capital for its operations and anticipated commercialization; (v) risks related to manufacturing complexity and supply chain for gene therapies; and (vi) risks of competition and rapidly evolving treatment landscape; as well as other risks and uncertainties that are described in greater detail in the section entitled "Risk Factors" in 4D Molecular Therapeutics’ most recent Quarterly Report on Form 10-Q filed on November 10, 2025, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statement represents 4D Molecular Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. 4D Molecular Therapeutics undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release, except as may be required by law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Contacts:

Media:
Jenn Gordon
dna Communications
Media@4DMT.com

Investors:
Julian Pei
Head of Investor Relations and Strategic Finance
Investor.Relations@4DMT.com

FAQ

When did 4DMT complete enrollment for the 4FRONT-1 Phase 3 trial (FDMT)?

Enrollment for 4FRONT-1 completed in approximately 11 months. According to 4D Molecular Therapeutics, the trial also over-enrolled and is expected to exceed 500 randomized patients.

How many patients are expected to be randomized in 4FRONT-1 (FDMT)?

4FRONT-1 is expected to exceed 500 randomized patients. According to 4D Molecular Therapeutics, the trial over-enrolled beyond initial projections, reflecting strong investigator and patient interest.

When will 4FRONT-1 topline primary endpoint data for 4D-150 (FDMT) be available?

Topline primary endpoint data from 4FRONT-1 is expected in H1 2027. According to 4D Molecular Therapeutics, this readout covers the 52-week non-inferiority BCVA endpoint.

What is the primary endpoint of 4FRONT-1 for 4D-150 (FDMT)?

The primary endpoint is non-inferiority in mean change in BCVA at 52 weeks. According to 4D Molecular Therapeutics, the trial compares intravitreal 4D-150 versus aflibercept 2 mg (Q8W).

What is the timeline and expectation for the 4FRONT-2 Phase 3 trial (FDMT)?

4FRONT-2 is expected to complete enrollment in H2 2026 with topline primary endpoint data expected in H2 2027. According to 4D Molecular Therapeutics, 4FRONT-2 enrolls both treatment-naïve and recently diagnosed treatment-experienced patients.

How does over-enrollment in 4FRONT-1 affect FDMT’s program prospects?

Over-enrollment suggests stronger-than-expected investigator and patient interest in 4D-150. According to 4D Molecular Therapeutics, this may improve statistical power and confidence ahead of the H1 2027 topline readout.