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A "productive" meeting with the FDA has given the firm confidence in its regulatory filing and commercialization plans for ST-920.
Phase II trial results indicated that treatment with the firm's antisense oligonucleotide led to stable or improved best-corrected visual acuity.
Patients on Enhertu followed by a chemotherapy and dual anti-HER2 regimen fared better than those on standard therapy.
The team is exploring whether biomarker testing could also identify patients who benefit more from immune checkpoint inhibitors after radiation.
The firm said it is in discussions with the FDA to resubmit its biologics license application seeking approval for Ebvallo.