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

Sanofi SNY has announced that the FDA has granted a fast-track designation to its one-time intravitreal gene therapy, SAR446597, for the treatment of geographic atrophy (GA) due to age-related macular degeneration (AMD).

How Does the Fast Track Status Help SNY's Drug Development?

The FDA’s Fast Track designation is intended to speed up the development and review of drugs that treat serious conditions and fulfill unmet medical needs. The regulatory body established this pathway to expedite the delivery of promising new therapies to patients, particularly those affected by serious or life-threatening conditions.

GA is an advanced stage of dry AMD that may result in irreversible vision loss. The condition affects around 1 million people in the United States and more than 5 million people worldwide.

SAR446597 is an investigational gene therapy aiming for long-lasting complement inhibition with a single injection, compared to currently available treatments, which require regular intravitreal injections. While still in the early-stage development, SAR446597 targets durable treatment of GA by inhibiting two key complement cascade pathways.

SAR446597 is designed to deliver genetic material encoding antibodies that block C1s and factor Bb, key drivers of the classical and alternative complement pathways. This dual action may offer lasting retinal complement suppression, reducing injection frequency and addressing complement-driven retinal disease with a single treatment.

SNY's Stock Performance

Year to date, shares of Sanofi have declined 0.2% against the industry’s rise of 0.4%.

More on Sanofi's Development of SAR446597

SAR402663 is currently being evaluated in a phase I/II study for the treatment of patients with neovascular wet age-related macular degeneration.

Sanofi plans to begin a phase I/II study to investigate the safety, tolerability and efficacy of SAR446597 for treating GA due to AMD shortly.

Presently, Apellis Pharmaceuticals APLS markets Syfovre (pegcetacoplan injection), which was the first treatment for geographic atrophy secondary to age-related macular degeneration to be approved by the FDA in 2023.

Per APLS, Syfovre is the market leader in GA, enjoying more than 60% share of the overall market.

Apellis recorded $611.9 million in Syfovre sales in 2024.

Astellas Pharma’s Izervay (avacincaptad pegol) is also approved by the FDA for treating geographic atrophy secondary to age-related macular degeneration.

Sanofi Price

 

Sanofi price | Sanofi Quote

SNY's Zacks Rank & Stocks to Consider

Sanofi currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the biotech sector are Arvinas ARVN and Akero Therapeutics AKRO, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Arvinas’ 2025 loss per share have improved from $1.60 to $1.51. Loss per share estimates for 2026 have narrowed from $3.28 to $2.98 during the same period. ARVN stock has plunged 61.4% year to date.

Arvinas’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 82.09%.

In the past 60 days, estimates for Akero Therapeutics’ 2025 loss per share have improved from $4.00 to $3.96. Loss per share estimates for 2026 have narrowed from $4.34 to $4.27 during the same period. Year to date, shares of AKRO have surged 86%.

Akero Therapeutics’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 48.90%.

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