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Spark Systems

Philadelphia, Pennsylvania, United States

Ownership: Private
Employees: ~750
Development stage: Other

Overview

First company to successfully commercialize a gene therapy for a genetic disease in the U.S. with FDA-approved Luxturna. Has delivered human proof-of-concept data in two target tissues (retina and liver) with breakthrough therapy designations. Phase III trials ongoing for hemophilia A treatment SPK-8011. Fidanacogene elaparvovec received FDA approval in 2024 for hemophilia B. Phase I/II dose-escalation trials for SPK-8016 (hemophilia A inhibitor patients), SPK-3006 (Pompe disease), SPK-1001 (Batten disease), and SPK-7001 (choroideremia) are underway.

Therapeutic areas: ImmunologyOphthalmologyNeurologyRare DiseasesHematology
Modalities: Gene therapy
Industry: Biotech

Partnerships

Pfizer (hemophilia B program)Genethon (SPK-3006 initial construct)

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