PGEN - Precigen gets FDA orphan drug designation for PRGN-2012

Precigen (PGEN) announces that the US FDA has granted orphan drug designation ((ODD)) for PRGN-2012, a first-in-class, investigational off-the-shelf ((OTS)) AdenoVerse immunotherapy for recurrent respiratory papillomatosis ((RRP)), a rare, difficult-to-treat and sometimes fatal neoplastic disease of the upper and lower respiratory tracts.PRGN-2012 is under development through a Cooperative Research and Development Agreement ((CRADA)) with the Center for Cancer Research ((CCR)) at the National Cancer Institute ((NCI)), which is part of the National Institutes of Health ((NIH)).In preclinical models, PRGN-2012 has showed strong and specific immune response against HPV 6 and HPV 11, the company said.Shares up nearly 2% premarket.

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Precigen gets FDA orphan drug designation for PRGN-2012