Vascular Biogenics, Ltd.
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VBL issued a press release on June 15, 2021 “provid[ing] an update on its ongoing OVAL Phase 3 study investigating ofranergene obadenovec (VB-111), for the treatment of platinum-resistant ovarian cancer.” Specifically, VBL disclosed that “[t]he Company was notified by the U.S Food and Drug Administration (FDA) that clearance of new VB-111 batches for use in the U.S. is currently pending the completion of a technical review by the Chemistry, Manufacturing, and Controls (CMC) group, which is evaluating the comparability of VB-111 manufacturing between different source sites. Until new batches are cleared, the Company anticipates a temporary shortage of study drug supply for the U.S. Accordingly, recruitment of new patients in the U.S. will be temporarily paused. Treatment will continue as usual for all U.S. patients currently enrolled. To-date, the study has enrolled approximately 75% of the planned 400-patients.” On June 15, 2021, VBL’s stock price fell sharply on this news during intraday trading.