CVM - CEL-SCI climbs 14% on plans to seek conditional approval for Multikine in Canada

2023-04-19 15:06:14 ET

CEL-SCI Corporation ( NYSE: CVM ) added ~15% Wednesday on above-average volume after disclosing a potential regulatory path to secure conditional approval in Canada for its lead asset, Multikine, targeted at patients with head & neck cancer.

The biotech said that following a pre-submission meeting, the country's drug regulator Health Canada advised it "to request advance consideration for approval of Multikine under a Notice of Compliance with Conditions policy."

According to the company, additional discussions with the regulator centered on post-market commitments and how to target patients with a lower risk of recurrence.

CEL-SCI ( CVM ) has enrolled Canadian patients for its global pivotal Phase 3 IT-MATTERS study, which was designed to evaluate the safety and clinical benefits of Multikine in over 900 patients with head and neck cancer.

"We continue to prepare our Biologics License Application for U.S. FDA approval while also pursuing marketing approval in other countries." Geert Kersten, Chief Executive of CVM remarked.

Read: With a Hold rating on the stock, Seeking Alpha analyst Out of Ignorance prefers to stay on the sidelines, noting that the company "has failed to provide any timeline for its BLA submission."

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