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. (Nasdaq: PGEN) is a pioneering biopharmaceutical company dedicated to discovering and developing next-generation gene and cellular therapies in the United States. Specializing in disease-modifying therapeutics, Precigen has been at the forefront of genetic engineering and synthetic biology solutions. The company excels in creating innovative therapies for some of the most challenging diseases in areas such as immuno-oncology, autoimmune disorders, and infectious diseases.
Precigen's core technologies include:
- UltraVector® Platform: This platform incorporates advanced DNA construction technologies and computational models to design and assemble genetic components into complex gene expression programs.
- UltraCAR-T® Cell Therapies: These therapies address limitations of conventional CAR-T therapies by improving in vivo CAR-T expansion and persistence, adding safety features, and reducing manufacturing costs.
- AdenoVerse™ Technology Platform: A library of engineered adenovector serotypes, including gorilla adenovectors, which is used for gene delivery, and modulating immune responses.
- RheoSwitch® Inducible Gene Switch: This technology allows for precise control over gene expression, making therapies safer and more efficient.
Recent achievements include the Phase 2 pivotal study data for PRGN-2012 in treating recurrent respiratory papillomatosis (RRP), a rare and debilitating disease. The study showcased promising results, with 51% of patients achieving Complete Response, defined as no need for surgical interventions in the 12-month period following treatment.
Precigen is also actively developing UltraCAR-T therapies, which have demonstrated significant preliminary efficacy and safety advantages over existing CAR-T therapies. These therapies are currently being evaluated in clinical trials for various hematological and solid tumors.
Financially, Precigen has shown resilience, focusing on sound fiscal management while advancing its clinical pipeline. Despite experiencing fluctuations in research expenses and revenues, the company remains committed to achieving its milestones and maintaining a strong balance sheet.
Precigen's business model involves commercializing its technologies through collaborations with industry partners who possess specialized expertise, development resources, and sales capabilities. This collaborative approach enables Precigen to bring new and improved products to market efficiently.
For the latest updates on Precigen's innovative gene and cell therapies, visit their official website and follow them on social media platforms like X (formerly Twitter), LinkedIn, and YouTube.
Precigen (Nasdaq: PGEN) has announced a proposed $30 million public offering of its common stock. The company intends to grant underwriters a 30-day option to purchase up to an additional $4.5 million of common stock. Stifel is acting as the sole book-running manager for the offering. The offering is subject to market conditions, and there's no assurance regarding its completion or final terms.
The public offering will be made pursuant to a shelf registration statement on Form S-3, effective since January 17, 2024. A preliminary prospectus supplement and accompanying base prospectus will be filed with the SEC. The offering's final terms will be disclosed in a final prospectus supplement to be filed with the SEC.
Precigen (PGEN) announced a strategic reprioritization of its clinical portfolio, focusing on the potential commercialization of PRGN-2012 AdenoVerse® gene therapy for recurrent respiratory papillomatosis (RRP). The company plans to submit a rolling BLA under an accelerated approval pathway in H2 2024, with a potential launch in 2025. Key points include:
- Workforce reduction of over 20%
- Continuation of PRGN-2009 Phase 2 trials with NCI for certain cancers
- Pausing of other UltraCAR-T clinical programs except PRGN-3006 for AML
- Shutdown of ActoBio subsidiary operations
- Pause of all preclinical programs
These changes aim to streamline resources and focus on PRGN-2012's potential commercialization, including BLA submission, confirmatory clinical trial, and manufacturing of commercial product.
Precigen (Nasdaq: PGEN) has appointed Phil Tennant as Chief Commercial Officer to lead commercial strategy and execution for potential launch of PRGN-2012 AdenoVerse gene therapy in recurrent respiratory papillomatosis (RRP). Tennant brings 30+ years of experience from biotech and pharma companies, including Merck, AstraZeneca, Bristol Myers Squibb, and Astellas Pharma. His expertise spans oncology, rare diseases, and global markets. At Astellas, he drove double-digit growth for a $5B oncology portfolio. Tennant will report to CEO Helen Sabzevari and join the executive leadership team, focusing on commercial readiness for PRGN-2012's potential US launch.
Precigen announced positive results from its Phase 1/2 pivotal study for PRGN-2012, a gene therapy for recurrent respiratory papillomatosis (RRP). In the study, 51% of patients achieved complete response, with no surgeries required post-treatment. Additionally, 86% of patients saw reduced surgical interventions. The treatment was well-tolerated, with no severe adverse events reported. The study showed significant improvements in patient quality of life and reduced disease severity. Precigen plans to submit a Biologics License Application (BLA) under an accelerated approval pathway in the second half of 2024, aiming for a potential launch in 2025.
Precigen (Nasdaq: PGEN) will host a webcast on June 3, 2024, at 6:00 PM CT/7:00 PM ET to discuss pivotal study results of PRGN-2012 for treating recurrent respiratory papillomatosis (RRP). The data will be presented earlier that day at 8:30 AM CT during the 2024 ASCO Annual Meeting. This Phase 2 study, led by Dr. Scott M. Norberg, demonstrates that PRGN-2012, a gorilla adenovirus-based immunotherapy, provides complete and durable responses in RRP patients. Participants can register and access the webcast via Precigen's website, and an archived recording will be available post-event. Precigen focuses on gene and cell therapies for immuno-oncology, autoimmune disorders, and infectious diseases, leveraging its AdenoVerse platform for advanced gene delivery and therapy development.
Precigen announced its Q1 2024 financial results and business updates, including pivotal Phase 2 data for PRGN-2012 to be presented at the ASCO Annual Meeting on June 3, 2024. A rolling BLA submission for PRGN-2012 is anticipated in the second half of 2024, with commercial readiness activities underway for a potential 2025 launch. Financially, the company reported $44.8 million in cash, cash equivalents, and short-term investments as of March 31, 2024, with a net loss of $23.7 million or $(0.10) per share. R&D expenses increased by 17%, while SG&A costs decreased by 13%. Key initiatives include PRGN-2009 trials for HPV-associated cancers and PRGN-3006 and PRGN-3005 trials for AML/MDS and ovarian cancer, respectively.
Precigen, Inc. (Nasdaq: PGEN) will report first quarter 2024 financial results on May 14, 2024, with a conference call on June 3, 2024. The company will discuss pivotal Phase 2 study data of PRGN-2012 for recurrent respiratory papillomatosis (RRP) at the 2024 ASCO Annual Meeting. Precigen focuses on gene and cell therapies for immuno-oncology, autoimmune disorders, and infectious diseases.
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