AIM ImmunoTech Inc's (NYSE: AIM) subsidiary, NV Hemispherx Biopharma Europe, has received formal notification from the European Commission for Orphan Medicinal Product Application for Ampligen as a treatment for pancreatic cancer.
Among other benefits, products with Orphan designation can enjoy up to ten years of protection from market competition from similar medicines with similar active components and indications.
Earlier, the Committee had recommended that Ampligen receive the designation for pancreatic cancer.
Two weeks ago, the Netherlands regulatory authority approved rintatolimod (Ampligen) treatment for six pancreatic cancer patients as part of a new, follow-up Early Access Program.
In September last year, a statistically significant positive pancreatic cancer survival benefit was observed in the Ampligen arm compared to a historical control cohort seen in a multi-year EAP conducted at Erasmus University Medical Center in the Netherlands.
Price Action: AIM stock gained 11.7% at $2.53 on the last check Wednesday.
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