SYN - Synthetic Biologics says VCN's therapy for retinoblastoma gets FDA's orphan drug status
Synthetic Biologics (NYSE:SYN) said VCN Biosciences' VCN-01 received the U.S. Food & Drug Administration's (FDA) orphan drug designation for retinoblastoma, a type of eye cancer. Synthetic Biologics is in the process of acquiring VCN. "We are highly encouraged by the preliminary clinical data thus far and look forward to conducting a pivotal Phase 2/3 trial in these patients following our expected completion of the acquisition," said Synthetic Biologics CEO and CFO Steven Shallcross. The FDA grants orphan drug status to therapies for conditions affecting fewer than 200K people in the U.S. The status provides various benefits including market exclusivity for seven years upon FDA approval. SYN +5.38% premarket to $0.30
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Synthetic Biologics says VCN's therapy for retinoblastoma gets FDA's orphan drug status