4D Molecular Poised For Success: FDA Discussion And Solid Position In Competitive Genetic Medicine Space, Says Analyst

Chardan Research analyst Geulah Livshits initiated coverage on 4D Molecular Therapeutics, Inc. FDMT with a Buy rating and price target of $30.

The analyst is particularly upbeat on the company's directed evolution of the Adeno-associated virus platform, or AAV, to tackle historical obstacles in vivo gene delivery (supported by early clinical data across lung, eye, and to an extent, heart). 

Encouraging safety in eye and lung positions 4D's anti‐VEGF (anti‐vascular endothelial growth factor) and CF programs for commercial feasibility and uptake if early activity signals play out in larger studies. 

Also Read: 4D Molecular Discloses Updated Data From Currently Paused Fabry Disease Cardiomyopathy Study

4D is advancing the asset for diabetic macular edema (DME), with 1st patient enrollment in the PII SPECTRA trial expected in 3Q23 and data in 2024, notes the analyst.

The analyst applauds the company's pipeline, which includes three clinical-stage ophthalmology assets, including intravitreal (IVT) anti-VEGF GT 4D-150 for wet age-related macular degeneration (wAMD).

The product showed clean safety and signals of durable benefit from phase I cohorts at ARVO in April. 

Although the lung is becoming a more competitive space for genetic medicines, clinical PoC on delivery with acceptable safety puts 4D in a solid position to build a pipeline. 

The analyst adds that discussion with the FDA on pivotal endpoints in 4Q should provide visibility on the path to market.

Price Action: FDMT shares are trading higher by 2.80% to $18.36 on the last check Wednesday.