PRGN-2012 has the potential to be the first- and best-in-class treatment for RRPCompany's BLA for PRGN-2012 for the treatment of adults with RRP is under priority review by the FDA with a PDUFA target action date set for August 27, 2025RRP is a rare, debilitating chronic disease with approximately 27,000 adult patients in the US and more than 125,000 patients outside of the USCompany continues to rapidly advance commercial and manufacturing readiness campaign in anticipation of 2025 commercial launch Company and Recurrent Respiratory Papillomatosis Foundation to host the 2025 International RRP Awareness Day on June 11Cash, cash equivalents, and investments of $81.0 million as of March 31, 20

– International event will raise awareness and bring together RRP patients, caregivers, and the healthcare community supporting them –– Recurrent respiratory papillomatosis is a rare, debilitating, chronic disease that impacts both children and adults and is mainly driven by HPV 6/11 infection –– There is no FDA-approved therapeutic for the treatment of RRP, and the current standard-of-care is repeated surgeries, which do not address the underlying cause of disease and are associated with significant morbidity and risk of irreversible injury – GERMANTOWN, Md., April 16, 2025 /PRNewswire/ -- Precigen, Inc. (NASDAQ:PGEN), a biopharmaceutical company specializing in the development of innovativ

FDA granted priority review to Company's BLA for PRGN-2012 for the treatment of adults with recurrent respiratory papillomatosis and set PDUFA target action date for August 27, 2025Results from pivotal clinical study of PRGN-2012 were published in The Lancet Respiratory MedicinePRGN-2012 treatment demonstrated durable complete responses with median duration of response of two years, with some complete responders surgery-free beyond three years as of August 28, 2024 data cutoffCompany continues to rapidly advance commercial and manufacturing readiness campaign in anticipation of 2025 commercial launchCompany ended 2024 with $97.9 million in cash, cash equivalents, and investments, extending i

GERMANTOWN, Md., March 13, 2025 /PRNewswire/ -- Precigen, Inc. (NASDAQ:PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced the Company will release full year 2024 financial results and provide business updates on Wednesday, March 19, 2025. The Company will host a conference call to discuss results that day at 4:30 PM ET. The conference call may be accessed by dialing 1-800-836-8184 (North America) or 1-646-357-8785 (International). Participants are asked to dial in 10-15 minu

– Priority review reduces the BLA review timeline to 6-months and is granted to therapies that, if approved, would provide significant improvements in the treatment, diagnosis or prevention of serious conditions – – If approved, PRGN-2012 would be the first and only available FDA-approved therapy for eligible patients with RRP, a rare and devastating chronic disease for which the current standard-of-care is repeated surgeries – GERMANTOWN, Md., Feb. 25, 2025 /PRNewswire/ -- Precigen, Inc. (NASDAQ:PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced the US Food and Drug Administration (FDA) h

–   PRGN-2012 has potential to be first FDA-approved therapeutic for treatment of RRP, a rare and devastating chronic disease – –   Company completed BLA submission for PRGN-2012 for treatment of adults with RRP – –   Commercial readiness activities underway in anticipation of potential launch of PRGN-2012; Company started 2025 with approximately $100 million cash on-hand* with cash runway well into 2026, beyond the anticipated launch in the second half of 2025 – –   According to recently updated internal analysis derived from review of claims data, the market opportunity for PRGN-2012 in RRP is estimated to be approximately 27,000 adult patients in the US – –   Immense market potential for

GERMANTOWN, Md., Jan. 9, 2025 /PRNewswire/ -- Precigen, Inc. (NASDAQ:PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced Helen Sabzevari, PhD, President and CEO of Precigen, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2025 at 9:00 AM PT in San Francisco, California. Participants may view details for this event through Precigen's website in the Events & Presentations section at investors.precigen.com/events-presentations. Precigen

–   PRGN-2012 has the potential to be the first FDA-approved therapeutic for the treatment of adults with RRP, a rare and devastating chronic disease for which the current standard-of-care is repeated surgeries – –   PRGN-2012 received Breakthrough Therapy Designation from the FDA and Orphan Drug Designation from the FDA and the European Commission ––   The BLA, under an accelerated approval pathway, is supported by data from the Phase 1/2 pivotal study in which more than 50% of patients achieved Complete Response and more than 85% of patients had a decrease in surgical interventions in the year after PRGN-2012 treatment compared to the year prior to treatment – –   PRGN-2012 was well-tolera

GERMANTOWN, Md., Dec. 27, 2024 /PRNewswire/ -- Precigen, Inc. (NASDAQ:PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that it has entered into a securities purchase agreement for the sale of its 8.00% Series A Convertible Perpetual Preferred Stock (Preferred Stock) in a private placement. Precigen anticipates gross proceeds from the private placement of $79.0 million before deducting offering expenses. In addition, the investors will have rights to exercise warrants to purchase 52,666,669 shares of Precigen's common stock at an exercise price of $0.75 per share (Warrants). The offering

–   Completed pre-BLA meeting with FDA with full alignment on content of BLA, including CMC module, and path for fourth quarter 2024 rolling BLA submission for PRGN-2012† in RRP under accelerated approval pathway – –   Commercial and manufacturing readiness campaign underway for PRGN-2012 in anticipation of a potential 2025 launch – –   Confirmatory clinical trial for PRGN-2012 in RRP was initiated in accordance with guidance from FDA to initiate prior to submission of the BLA; continuing enrollment – –   Preparing for end of Phase 1b meeting with FDA in early 2025 for PRGN-3006 in AML – –   Presented preclinical data at SITC 2024 for PRGN-3008, a next generation UltraCAR-T targeting CD19 sh

4 - PRECIGEN, INC. (0001356090) (Issuer)

4 - PRECIGEN, INC. (0001356090) (Issuer)

4 - PRECIGEN, INC. (0001356090) (Issuer)

4 - PRECIGEN, INC. (0001356090) (Issuer)