Precigen Gives Business Updates, Significant Progress Made In The Development Of The PRGN-2012 Adenoverse Immunotherapy For The Treatment Of RRP; Plans To Submit A BLA Under An Accelerated Approval Pathway In 2H Of 2024

Author: Benzinga Newsdesk | March 19, 2024 04:11pm

–   Significant progress made in the development of the PRGN-2012 AdenoVerse immunotherapy for the treatment of RRP; Precigen plans to submit a BLA under an accelerated approval pathway in the second half of 2024; ramping up commercial readiness activities for a potential launch in 2025 –

–   Precigen's PRGN-2012 received the first Breakthrough Therapy Designation and accelerated approval pathway from the FDA for the treatment of RRP –

–   Precigen received IND clearance for a randomized Phase 2 study of PRGN-2009 AdenoVerse immunotherapy in combination with pembrolizumab in HPV-associated recurrent/metastatic cervical cancer; study now active and recruiting patients –

–   Interim data from the ongoing Phase 1b study of PRGN-3006 UltraCAR-T in relapsed/refractory AML anticipated in the second half of 2024 –

–   Preliminary data from the Phase 1 study of PRGN-3007 next generation UltraCAR-T in ROR1+ advanced cancers anticipated in the second half of 2024 –

–   Cash, cash equivalents, short-term and long-term investments totaled $62.9 million as of December 31, 2023 –

–   Continued focus on cost containment resulted in a reduction in SG&A costs of 16% for the twelve months ended December 31, 2023, compared to the prior year period –

Posted In: PGEN