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.
Precigen Inc (PGEN) is a clinical-stage biopharmaceutical leader advancing next-generation gene and cell therapies through its proprietary synthetic biology platforms. This page aggregates official news, press releases, and regulatory developments related to PGEN's innovative research in immuno-oncology, autoimmune disorders, and infectious diseases.
Investors and industry professionals will find timely updates on clinical trial progress, strategic partnerships, and technological breakthroughs leveraging PGEN's UltraCAR-T and AdenoVerse platforms. The curated content supports informed decision-making by providing transparent access to the company's scientific advancements and operational milestones.
Key updates include announcements about therapeutic candidate developments, manufacturing innovations, and collaboration agreements that demonstrate PGEN's position at the forefront of precision medicine. All content is sourced directly from company communications to ensure accuracy and compliance.
Bookmark this page for streamlined access to Precigen's latest developments in gene-editing technologies and cellular therapeutics. Regularly updated to reflect PGEN's evolving pipeline and strategic initiatives.
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.
Precigen (PGEN) reported Q2 and H1 2024 financial results, highlighting key developments for its lead program PRGN-2012 in recurrent respiratory papillomatosis (RRP):
- Pivotal study data showed 51% of RRP patients achieved Complete Response
- Rolling BLA submission anticipated in H2 2024
- Confirmatory trial enrollment initiated
- Appointed new CCO to lead potential 2025 commercial launch
- Raised $31.4M via public offering
The company is prioritizing PRGN-2012 advancement and streamlining other programs. Q2 net loss was $58.8M vs $20.3M in Q2 2023, impacted by $32.9M impairment charge. R&D expenses increased 32% YoY to $15.7M. Cash expected to fund operations into early 2025.
Precigen (Nasdaq: PGEN), a biopharmaceutical company focused on innovative gene and cell therapies, has announced it will release its second quarter and first half 2024 financial results on August 14, 2024. The company will host a conference call at 4:30 PM ET on the same day to discuss the results and provide a business update. Investors can access the call by dialing 1-800-836-8184 (North America) or 1-646-357-8785 (International). Participants are advised to dial in 10-15 minutes early. Event details are available on Precigen's website in the Events & Presentations section.
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