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Oncolys BioPharma shares surge on regulatory compliance approval for OBP-301
Oncolys BioPharma Inc. <4588> extended its sharp rally on news that it has cleared a major regulatory hurdle. Following the market close on April 3, the company announced it received a "compliance" notification from the PMDA after an on-site GCP inspection and document review for its oncolytic virus, OBP-301.
This inspection was a key step in the approval process for the esophageal cancer treatment, for which Oncolys filed an NDA (New Drug Application) last December. The update sparked significant buying interest as the path to commercialization becomes clearer. Pending final approval from the MHLW, the company aims to launch OBP-301 within the fiscal year ending December 2026.
Source: MINKABU PRESS
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