Welcome to our dedicated page for Precigen news (Ticker: PGEN), a resource for investors and traders seeking the latest updates and insights on Precigen stock.
Overview of Precigen Inc (PGEN)
Precigen Inc is a clinical stage biopharmaceutical company that develops and refines innovative gene and cell therapies using cutting-edge synthetic biology and precision technology. With proprietary platforms such as UltraCAR-T and AdenoVerse, the company designs, builds, and regulates complex gene expression programs to address intractable diseases. Its expertise in non-viral gene transfer methods and advanced DNA construction techniques positions the company as a significant innovator across multiple therapeutic areas including immuno-oncology, autoimmune disorders, and infectious diseases.
Core Business and Technological Platforms
Precigen leverages a comprehensive suite of technologies to discover and develop next generation therapeutics. The company utilizes an advanced UltraVector platform for DNA construction, facilitating the design and assembly of gene components. Its UltraCAR-T platform, which employs a non-viral Sleeping Beauty system, enables the rapid manufacturing of personalized cell therapies with an improved safety profile and simplified logistics. Additionally, the AdenoVerse platform uses a library of engineered adenovector serotypes that efficiently deliver gene therapies aimed at modulating immune responses.
Business Model and Collaborations
The business model of Precigen is centered on leveraging its proprietary technology platforms through strategic collaborations with industry experts who bring extensive development, manufacturing, and commercial capabilities. These partnerships generate revenue primarily via technology access fees, milestone payments, royalties, and reimbursement of collaborative costs. This model provides a stable framework for continuous innovation and the effective translation of preclinical discoveries into viable clinical therapies.
Market Position and Competitive Landscape
In the competitive biotechnology arena, Precigen distinguishes itself through its robust research capabilities and a diversified portfolio of therapeutic candidates. Its unique non-viral gene transfer methods and rapid manufacturing techniques set it apart from traditional gene and cell therapy developers. By focusing resources on technologies with high clinical and commercial potential, the company addresses critical unmet needs in the therapeutic landscape, thereby reinforcing its market significance.
Operational Focus and Expertise
Precigen’s operations are built on years of scientific expertise in genetic engineering and computational model integration for therapeutic design. The company’s detailed approach to tailoring gene expression programs allows for improved functional characteristics of immune cells and precise control over therapeutic outcomes. Its methodical approach and dedication to iterative clinical development underscore its commitment to advancing medicine with precision.
Summary of Value Proposition
Precigen excels in translating complex genetic information into transformative therapies with the potential to modify the disease course in challenging therapeutic areas. By continually streamlining its research and operational models, the company ensures that its innovative techniques remain at the forefront of scientific excellence and commercial relevance. The integrated approach of technology, clinical expertise, and strategic partnerships makes Precigen a notable entity within the biopharmaceutical industry.
Precigen (PGEN) announced its full year 2024 financial results and significant progress with its lead therapy PRGN-2012. The FDA granted priority review for PRGN-2012's BLA with a PDUFA date of August 27, 2025, potentially making it the first FDA-approved treatment for recurrent respiratory papillomatosis (RRP).
Key clinical highlights include:
- 51% of patients achieved Complete Response with no required surgeries after treatment
- 86% of patients showed decreased surgical interventions
- Median duration of response was 2 years, with some patients surgery-free beyond 3 years
Financial position:
- Ended 2024 with $97.9 million in cash and investments
- Raised $87.5 million through preferred stock offering and asset sale
- Extended cash runway into 2026
- Net loss of $126.2 million ($0.47 per share) compared to $95.9 million in 2023
Precigen (PGEN), a biopharmaceutical company focused on gene and cell therapies, has scheduled the release of its full year 2024 financial results for March 19, 2025. The company will host a conference call at 4:30 PM ET to discuss the results and provide business updates.
Investors can access the conference call by dialing 1-800-836-8184 (North America) or 1-646-357-8785 (International). Participants should dial in 10-15 minutes before the scheduled call time. Additional event details are available on Precigen's website under the Events & Presentations section.
Precigen specializes in developing next-generation gene and cell therapies targeting immuno-oncology, autoimmune disorders, and infectious diseases using precision technology. The company focuses on creating affordable biotherapeutics through controlled innovation.
Precigen, Inc. (PGEN) announced that the FDA has granted priority review to its biologics license application (BLA) for PRGN-2012 (zopapogene imadenovec), an investigational AdenoVerse gene therapy for treating adults with recurrent respiratory papillomatosis (RRP).
The FDA set a PDUFA target action date of August 27, 2025, with no advisory committee meeting currently planned. If approved, PRGN-2012 would become the first and only FDA-approved therapy for RRP, a rare and devastating chronic disease caused by HPV 6 or HPV 11 infection.
The BLA is supported by pivotal Phase 1/2 clinical study data showing impressive results:
- Over 50% of patients achieved Complete Response
- More than 85% experienced decreased surgical interventions
- Some patients have remained surgery-free for over three years
- The treatment was well-tolerated with no serious adverse events
RRP currently has no cure, with patients relying on repeated surgeries that don't address the underlying cause and can lead to cumulative laryngeal injury. The US adult RRP patient population is estimated at more than 27,000.
Precigen (PGEN) has completed its BLA submission for PRGN-2012, potentially the first FDA-approved treatment for Recurrent Respiratory Papillomatosis (RRP). The company starts 2025 with approximately $100 million cash on-hand and runway extending well into 2026, beyond the anticipated launch in second half of 2025.
The market opportunity for PRGN-2012 includes approximately 27,000 adult RRP patients in the US and over 125,000 patients ex-US. The therapy has shown promising results with over 50% of patients achieving Complete Response and more than 85% experiencing decreased surgical interventions in clinical trials.
The company sees significant potential in expanding their AdenoVerse platform to other HPV-related conditions, including genital warts (4+ million annual global incidence) and HPV16/18-driven cancers. Manufacturing readiness is progressing with a 100% success rate to date at their in-house commercial facility.
Precigen (Nasdaq: PGEN), a biopharmaceutical company focused on innovative gene and cell therapies, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. Dr. Helen Sabzevari, the company's President and CEO, will deliver a presentation on Thursday, January 16, 2025, at 9:00 AM PT in San Francisco, California.
The company specializes in developing next-generation gene and cell therapies using precision technology, targeting three core therapeutic areas: immuno-oncology, autoimmune disorders, and infectious diseases. Their approach focuses on creating affordable biotherapeutics through controlled innovation, with an active preclinical and clinical pipeline progressing toward clinical proof-of-concept and commercialization.
Precigen (PGEN) has completed its Biologics License Application (BLA) submission to the FDA for PRGN-2012, a potential first FDA-approved treatment for adults with Recurrent Respiratory Papillomatosis (RRP). The therapy received Breakthrough Therapy Designation and Orphan Drug Designation from both FDA and European Commission. The BLA submission includes compelling Phase 1/2 pivotal study results where over 50% of patients achieved Complete Response and more than 85% experienced decreased surgical interventions in the year following treatment. The company has requested priority review, which could reduce the FDA review timeline from 10 to 6 months. PRGN-2012 demonstrated strong safety profile with no treatment-related adverse events above Grade 2.
Precigen (PGEN) has announced a private placement offering of 8.00% Series A Convertible Perpetual Preferred Stock, expecting to raise $79.0 million in gross proceeds. The deal includes warrants to purchase 52,666,669 shares at $0.75 per share. The placement was led by Patient Capital Management affiliates, with participation from Bill Miller and Randal J. Kirk.
The Preferred Stock is convertible into common stock at $1.125 per share after six months and shareholder approval. Dividends will be paid annually, with the first two years paid in kind. The company expects this financing to extend its cash runway well into 2026, beyond the anticipated commercial launch of PRGN-2012 in the second half of 2025.
Precigen (PGEN) reported Q3 2024 financial results and key updates. The company completed pre-BLA meetings with FDA and is aligned for Q4 2024 rolling BLA submission of PRGN-2012 for RRP under accelerated approval. Commercial and manufacturing preparations are underway for potential 2025 launch. Q3 net loss was $24.0 million ($0.09 per share) compared to $19.8 million ($0.08 per share) in Q3 2023. The company raised $30.9 million through a public offering in August 2024 and implemented strategic prioritization, including 20% workforce reduction, to focus on PRGN-2012 commercialization.
Precigen (Nasdaq: PGEN) has announced its participation in the Stifel 2024 Healthcare Conference in New York. Helen Sabzevari, PhD, President and CEO, will engage in a fireside chat on Tuesday, November 19, 2024, from 10:55 to 11:25 AM ET. The conference is scheduled for November 18-19, 2024.
Precigen is a discovery and clinical stage biopharmaceutical company focused on developing next-generation gene and cell therapies. The company specializes in precision technology targeting immuno-oncology, autoimmune disorders, and infectious diseases, working to create affordable biotherapeutics through controlled innovation.
Precigen (Nasdaq: PGEN), a biopharmaceutical company focused on innovative gene and cell therapies, announced its participation in the 2024 Cantor Global Healthcare Conference. Helen Sabzevari, PhD, President and CEO of Precigen, will engage in a fireside chat on September 18, 2024, from 9:45 to 10:15 AM ET in New York.
The conference, scheduled for September 17-19, 2024, provides a platform for Precigen to showcase its advancements in precision medicine. Precigen specializes in developing therapies for immuno-oncology, autoimmune disorders, and infectious diseases using cutting-edge gene and cell therapy technologies. Interested parties can access event details through Precigen's website in the Events & Presentations section.
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