SNY's Gene Therapy Candidate for Eye Disease Gets FDA Fast Track Tag

Sanofi SNY announced that the FDA granted fast track designation to its investigational gene therapy, SAR402663, for the treatment of neovascular (or wet) age-related macular degeneration (AMD).

How Does the Fast Track Tag Benefit SNY’s Drug Development?

Fast track designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions, fill an unmet medical need, or offer a potential advantage over existing treatments. Per the FDA, the purpose of granting this designation is to ‘get important new drugs to the patient earlier.’

A candidate with the fast track designation is also eligible for rolling review. This will allow Sanofi to submit completed sections of its regulatory filing for SAR402663 to the FDA as they become available, rather than waiting for the entire application to be finalized. This can potentially expedite the evaluation process, as the FDA typically does not begin reviewing a submission until all sections of the application have been filed.

SNY’s Stock Performance

Shares of Sanofi have underperformed the industry year to date, as seen in the chart below.

More on Sanofi’s SAR402663

An investigational one-time intravitreal gene therapy, SAR402663, is designed to inhibit vascular endothelial growth factor (VEGF) — a key driver of abnormal blood vessel growth in the eye. By targeting this pathway, the therapy aims to address the underlying disease pathology while reducing treatment burden by eliminating the need for frequent intravitreal injections.

Sanofi is currently evaluating SAR402663 in a phase I/II study for neovascular/wet AMD, a severe form of macular degeneration caused by growth of abnormal blood vessels beneath the retina. The condition, which can lead to vision loss and, in advanced stages, blindness, affects more than a million people in the United States.

Rival Gene Therapy Programs for Wet AMD

A key competitor to Sanofi’s SAR402663 is ABBV-RGX-314, a one-shot gene therapy being developed by AbbVie ABBV in partnership with Regenxbio RGNX. Also designed to target VEGF, this ABBV/RGNX candidate is being evaluated in pivotal studies for wet AMD, with data expected next year. AbbVie and Regenxbio are planning to start a late-stage program on ABBV-RGX-314 in patients with diabetic retinopathy (DR).

Another close competitor to the Sanofi therapy is 4D Molecular Therapeutics’ FDMT lead pipeline candidate, 4D-150. Like SAR402663 and ABBV-RGX-314, 4D Molecular’s gene therapy candidate is also designed to target VEGF and is currently being evaluated in two late-stage studies for wet AMD. Data from these two studies are expected in the second half of 2027. FDMT also intends to start late-stage studies on 4D-150 in diabetic macular edema (DME).

Sanofi Price

 

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SNY’s Zacks Rank

Sanofi currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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