Germantown’s Precigen Inc., a clinical-stage biotech developing gene and cell therapies for cancers and other diseases, is taking steps to get an experimental treatment to regulators for review this year — which could pave the path for a market launch in 2025.
The 26-year-old Precigen (NASDAQ: PGEN) has been advancing an immunotherapy to treat a rare disease most common in kids called recurrent respiratory papillomatosis, or RRP. It’s on track to wrap up a phase 2 clinical trial in the second quarter that, if successful, could set it up for the Food and Drug Administration’s signoff to get it to patients next year.
“2024 is poised to be a transformative year for us at Precigen, especially as we transition from a clinical to a commercial company,” President and CEO Helen Sabzevari said on a company earnings call Tuesday.
To prepare for its first-ever sale of its own product — it has historically generated revenue from licensing deals and services — Precigen is expanding its manufacturing capacity within its Germantown facility by converting existing office space, a company spokesperson told me. Tied to that expansion, it has already increased its headcount across positions in manufacturing, quality control and quality assurance, and expects to bring on more employees “as we proceed towards potential commercialization,” the spokesperson said.
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