Ahmad Bilal Precigen ( NASDAQ: PGEN ) stock fell 13% in post-market trading Tuesday after the company announced it was laying off 20% of its workforce and pausing some programs to focus on commercializing its AdenoVerse gene therapy PRGN-2012. The biotech company said it will concentrate on submitting a rolling FDA Biologics License Application under an accelerated approval pathway for PRGN-2012 in the second half of the year, with a potential launch in 2025. The company has been developing the gene therapy as a treating recurrent respiratory papillomatosis.
In order to focus on PRGN-2012’s development, Precigen ( PGEN ) is pausing its UltraCAR-T programs, including PRGN-3005 and PRGN-3007, and will instead seek out partners for the programs. It intends to meet with the FDA at the end of a Phase 1b study for PRGN-3006, which is being tested for acute myeloid leukemia, to discuss the next steps for the therapy, according to a statement . While Phase 2 clinical trials for its PRGN-2009 AdenoVerse gene therapy will continue, the company plans to cease enrollment at certain sites.
The company also plans to pause all preclinical programs. Precigen ( PGEN ) also intends to shut down its ActoBio subsidiary, which will include the elimination of all personnel. Precigen ( PGEN ) will then make ActoBio's intellectual property portfolio available for possible transactions.
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