Soligenix Inc. (NASDAQ: SNGX) Strengthens CTCL Program as DMC Flags No Safety Issues
This milestone is significant because regulatory pathways for orphan diseases such as CTCL often hinge not only on efficacy, but on establishing a favorable safety profile. Soligenix’s announcement arrives amid mounting interest in HyBryte[TM] as a novel skin-directed therapy. For biotechnology companies working in rare diseases, reaching a safety milestone means one major hurdle is cleared and focus can shift more explicitly to efficacy and regulatory strategy. In a key development that underscores the advancing clinical trajectory of its lead therapy, Soligenix (NASDAQ: SNGX) announced that the Data Monitoring Committee (“DMC”) overseeing its confirmatory Phase 3 FLASH2 trial of HyBryte(TM)…