Bavarian start-ups VeonGen receives FDA special status for gene therapy against most common retinal disease The Planegg-based company VeonGen Therapeutics has received RMAT (Regenerative Medicine Advanced Therapy) status from the FDA for its VG801 gene therapy for Stargardt disease. The therapy targets ABCA4 mutations and thus the genetic cause of the disease. The RMAT, Orphan Drug, and Rare Pediatric Disease designations are intended to accelerate clinical testing. y a b a x P © i VeonGen Therapeutics, which develops next-generation gene therapies, has been granted Regenerative Medicine Advanced Therapy (RMAT) status by the US Food and Drug Administration (FDA) for VG801, its leading gene therapy for the treatment of Stargardt disease and other retinal dystrophies associated with ABCA4 mutations. By delivering a functional, full-length ABCA4 gene, VG801 has the potential to address the underlying genetic cause of Stargardt disease in all ABCA4 mutations. RMAT is a designation granted by the FDA for regenerative medicine therapies, including gene therapies, that are being developed to treat, modify, reverse, or cure serious or life-threatening conditions. The RMAT designation enables enhanced collaboration with the FDA, opportunities for streamlined clinical and industrial development, potential priority review of a Biologics License Application (BLA), and other avenues for accelerating development and review. Read more Vivoryon Therapeutics raises 5.1 million euros through private placement of new shares Vivoryon Therapeutics N.V., a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, has completed a private placement of new shares to selected investors with gross proceeds in the amount of EUR 5.1 million. The proceeds provide financial leeway and flexibility to pursue a strategic partnership for varoglutamstat in chronic kidney disease. Pursuant to the results of the offering, the company will issue 3,380,500 new ordinary shares at an offering price of EUR 1.50 per share, amounting to gross proceeds of EUR 5.1 million. The new shares issued pursuant to the offering represent 12.9% of Vivoryon’s existing issued share capital and will be issued from the company’s authorized capital under exclusion of the existing shareholders’ pre-emptive rights. As a consequence, the company’s number of shares outstanding will increase to 29,614,337 and the company’s share capital will increase from EUR 262,338.37 by EUR 33,805.00 to EUR 296,143.37 on completion of the offering. Read more Bavarian Biotech News, October 2025 www.bio-m.org y a b a x P © i 5