Precigen | MedPath

CAR-T Cell Therapy Funding Surges to $141.2 Billion as Industry Expands Globally

11 days ago

• The CAR-T cell therapy industry has raised over $141.2 billion through various financing mechanisms, with estimates suggesting total industry funding could reach $281.7 billion when including undisclosed deals. • More than 170 companies worldwide are developing CAR-T products with 1,944 therapies in development, while 13 CAR-T cell therapies have received regulatory approval globally since 2017. • Despite a slowdown in IPOs and M&A activity in 2024, venture capital funding remains strong with 89 CAR-T companies securing $7.7 billion since 2014, supporting advancement in both blood cancer and solid tumor applications.

U.S. Monoclonal Antibodies Market Projected to Reach $284.9 Billion by 2034, Growing at 13.1% CAGR

3 months ago

• The U.S. monoclonal antibodies market is expected to grow from $94.09 billion in 2025 to $284.90 billion by 2034, driven by rising prevalence of chronic diseases and expanding therapeutic applications beyond oncology. • Human-source monoclonal antibodies dominated the market with 34.3% share in 2024, while oncology applications led with 38.2% of market value, reflecting the critical role of mAbs in targeted cancer therapies. • Artificial intelligence integration is revolutionizing the mAb industry by accelerating drug discovery, optimizing manufacturing processes, and enabling more personalized treatments with improved efficacy and reduced development costs.

Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments

5 months ago

• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions. • Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways. • These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets. • The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.

CAR-T Cell Therapy Industry Surges to $141.2 Billion in Funding as Clinical Success Drives Investment

5 months ago

• The CAR-T cell therapy industry has raised over $141.2 billion through various financing mechanisms, with potential total value reaching $281.7 billion when including undisclosed deals. • Since 2014, 89 CAR-T companies have secured $7.7 billion in venture capital funding, while 42 companies have raised $6.4 billion through IPOs, demonstrating sustained investor confidence. • Despite a slowdown in M&A activity in 2024, the sector continues to expand with 170+ companies developing 1,944 therapies, including 244 trials targeting solid tumors beyond the current blood cancer focus.

FDA Grants Priority Review to Precigen's PRGN-2012 for Recurrent Respiratory Papillomatosis

5 months ago

• The FDA has accepted Precigen's Biologics License Application for PRGN-2012 with priority review, setting a PDUFA target action date of August 27, 2025 for the potential first-ever approved therapy for recurrent respiratory papillomatosis. • PRGN-2012, an AdenoVerse gene therapy, demonstrated remarkable efficacy in clinical trials with over 50% of patients achieving complete response and more than 85% experiencing reduced surgical interventions, addressing a significant unmet need. • If approved, PRGN-2012 would transform treatment for approximately 27,000 adult RRP patients in the US who currently rely on repeated surgeries that don't address the underlying HPV 6/11 infection.

Inovio's SWOT Analysis: Biotech Stock Faces Manufacturing Hurdles Amid Pipeline Progress

5 months ago

Inovio Pharmaceuticals, Inc., a biotechnology company focused on developing treatments for infectious diseases and cancer, is navigating through clinical advancements and operational challenges. Despite a promising product pipeline, including its lead program for recurrent respiratory papillomatosis (RRP), the company faces manufacturing setbacks that have delayed its regulatory timeline. Inovio's financial stability is under scrutiny as it burns through cash reserves, despite having a healthy current ratio. The company's future success hinges on resolving manufacturing issues, advancing its clinical trials, and navigating the competitive biotech landscape.

Precigen Advances PRGN-2012 for RRP Towards BLA Submission

6 months ago

• Precigen is set to submit a rolling BLA for PRGN-2012 in recurrent respiratory papillomatosis (RRP) in Q4 2024 under an accelerated approval pathway. • The company's pivotal study showed that 51% of RRP patients achieved complete response with PRGN-2012, requiring no surgeries post-treatment. • Preclinical data presented at SITC 2024 highlights PRGN-3008, a next-generation UltraCAR-T targeting CD19, with potential for oncology and autoimmune diseases. • Precigen is preparing for an end-of-Phase 1b meeting with the FDA in early 2025 for PRGN-3006 in acute myeloid leukemia (AML).

Precigen Announces Progress on PRGN-2012 for Recurrent Respiratory Papillomatosis

6 months ago

• Precigen completed a pre-BLA meeting with the FDA, achieving full alignment on the BLA content for PRGN-2012, targeting a rolling submission in Q4 2024. • Commercial and manufacturing readiness campaigns are underway for PRGN-2012, anticipating a potential launch in 2025 for recurrent respiratory papillomatosis. • A confirmatory clinical trial for PRGN-2012 has been initiated, following FDA guidance, with ongoing patient enrollment to support the BLA submission. • Preclinical data presented at SITC 2024 highlights PRGN-3008, a next-generation UltraCAR-T therapy targeting CD19, showing promise as a best-in-class treatment for oncology and autoimmunity.

Precigen Announces Second Quarter and First Half 2024 Financial Results and Business Updates

9 months ago

Precigen, Inc. reported its financial results for the second quarter and first half of 2024, highlighting significant advancements in its PRGN-2012 gene therapy for recurrent respiratory papillomatosis (RRP), strategic portfolio reprioritization, and financial maneuvers to strengthen its cash position.

Breakthroughs in Biotech: Promising Developments in Diabetes, Cancer, and Lymphoma Treatments

2 years ago

Recent advancements in the biotech sector highlight significant progress in treatments for diabetes, breast cancer, multiple myeloma, and T cell lymphoma, with several companies receiving FDA approvals or making notable strides in clinical trials.