PRGN-2012

2024 was a challenging year for the biopharma industry, with companies like Bayer, Bristol Myers Squibb, and Johnson & Johnson cutting hundreds to thousands of jobs. Cassava Sciences announced layoffs of 10 employees, 33% of its workforce, following a failed Phase III trial for its Alzheimer's drug. CytomX Therapeutics cut 40% of its staff to focus on clinical programs. Velia, a San Diego biotech, is shutting down, affecting 47 employees. Regeneron's acquisition of Oxular led to layoffs, with no Oxular employees joining Regeneron. Javara, Ring Therapeutics, Outlook Therapeutics, Editas, Bavarian Nordic, BenevolentAI, Chroma Medicine and Nvelop Therapeutics, Cellectar Biosciences, Carisma Therapeutics, Belharra Therapeutics, National Resilience, AmplifyBio, Agenus, Alligator Bioscience, Idorsia Pharmaceuticals, Kronos Bio, Novartis, Recursion Therapeutics, Medigene, Alector, Bristol Myers Squibb, Sonata Therapeutics, 23andMe, Johnson & Johnson, Merck, Gilead Sciences, Adaptimmune, Sensei Biotherapeutics, Marinus Pharmaceuticals, Orna Therapeutics, Thermo Fisher Scientific, Charles River Laboratories, Aurinia Pharmaceuticals, Viracta Therapeutics, Astellas Gene Therapies, Sana Biotechnology, Sage Therapeutics, Compass Pathways, Spero Therapeutics, ICON, Pfizer, Takeda, SalioGen Therapeutics, Evonik, Medtronic, CareFusion Resources, Turnstone Biologics, Leo Pharma, Astellas Pharma, Prime Medicine, Kaléo, Stryker, Relay Therapeutics, ImmunityBio, Shattuck Labs, Inventprise, bluebird bio, Athira Pharma, AGC Biologics, Oncternal Therapeutics, Biosense Webster, Vesigen Therapeutics, Connect Biopharma, BioMarin, IN8bio, Edwards Lifesciences, DermTech, Repare Therapeutics, Genentech, Tome Biosciences, Aadi Bioscience, Lykos Therapeutics, Evotec, Galera Therapeutics, Grail, Ovid Therapeutics, Lexicon Pharmaceuticals, Acelyrin, Boundless Bio, FibroGen, Ajinomoto Bio-Pharma Services, AN2 Therapeutics, Entero Therapeutics, Precigen, Sumitomo Pharma America, uniQure, Vir Biotechnology, Arbutus Biopharma, HilleVax, and Bayer also announced significant layoffs, reflecting a tough year for the industry.

Precigen completed a BLA submission to the FDA for PRGN-2012, a gene therapy for RRP, seeking priority review. PRGN-2012 targets HPV 6/11, offering potential as the first FDA-approved RRP treatment. Supported by phase 1/2 study data, it aims to reduce surgeries and improve patient quality of life.

Precigen's shares surged after submitting a biologics license application to the FDA for PRGN-2012, a potential first treatment for recurrent respiratory papillomatosis. The gene therapy targets HPV infections and has received FDA designations. The application seeks priority review to expedite approval.

PRGN-2012, a gene therapy by Precigen, Inc., aims to treat recurrent respiratory papillomatosis (RRP) in adults, potentially becoming the first FDA-approved therapy for this condition. It has received Breakthrough Therapy and Orphan Drug Designations, showing promise in reducing surgical interventions and achieving Complete Response in over 50% of patients.

Precigen, Inc. shares surged after completing a biologics license application to the FDA for PRGN-2012, a potential first treatment for recurrent respiratory papillomatosis, a rare condition with no cure. The therapy targets HPV infections and has received FDA designations, with a Phase 1/2 study meeting safety and efficacy endpoints.

PRGN-2012, a gene therapy by Precigen, Inc., targets HPV 6/11 in adults with RRP, showing over 50% Complete Response and reduced surgeries. It's under FDA review, aiming to be the first RRP treatment, supported by Phase 1/2 study data.

Precigen completed BLA submission for PRGN-2012, a potential first FDA-approved therapy for RRP, supported by Phase 1/2 study data showing over 50% Complete Response and reduced surgeries.

Precigen's shares rose after submitting a biologics license application to the FDA for PRGN-2012, a gene therapy targeting HPV 6 and 11, aiming to treat recurrent respiratory papillomatosis. With Breakthrough Therapy and Orphan Drug Designations, PRGN-2012 could be the first FDA-approved treatment for this condition, backed by positive Phase 1/2 study results. The FDA's review could lead to a priority review, shortening the timeline. Precigen's CEO emphasized the importance of this step towards providing a therapy for RRP patients, with a potential commercial launch in 2025.

Precigen reports Q3 2024 financial results and business updates, including completion of pre-BLA meeting with FDA for PRGN-2012, commercial and manufacturing readiness for potential 2025 launch, initiation of confirmatory clinical trial for PRGN-2012, and preparation for end of Phase 1b meeting with FDA for PRGN-3006 in AML. Preclinical data for PRGN-3008 presented at SITC 2024 showcasing potential as best-in-class CD19-targeting CAR-T treatment.