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PAPZIMEOS's full FDA approval for RRP is a decisive, de-risking event and validates Precigen's immunotherapy platform. PAPZIMEOS targets a significant unmet need, with potential for $1B+ peak sales, though logistical hurdles and launch friction exist. Precigen faces imminent financing needs due to limited cash runway and increased burn from its first commercial launch.

On Friday, the U.S. Food and Drug Administration (FDA) approved Precigen Inc.'s PGEN Papzimeos (zopapogene imadenovec-drba) for adult patients with recurrent respiratory papillomatosis (RRP).

The U.S. Food and Drug Administration has approved Precigen's immunotherapy to treat adults with a rare respiratory disease, making it the first treatment for the condition to receive the health regulator's nod.

PAPZIMEOS approval marks a historic milestone for the RRP patient community as the first and only FDA-approved therapy for the treatment of adults with RRP PAPZIMEOS received full approval from the FDA for the treatment of adults with RRP; a confirmatory clinical trial is no longer required  RRP is a rare, debilitating, and potentially life-threatening disease caused by chronic HPV 6 or HPV 11 infection, which results in recurrent benign tumors in the respiratory tract; RRP affects an estimated 27,000 adult patients in the US PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to generate an immune response directed against papilloma cells expressing HPV 6/11—the first and only approved therapy to treat the root cause of RRP Precigen will host a conference call on Monday, August 18 at 8:00 AM ET GERMANTOWN, Md , Aug. 15, 2025 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the advancement of innovative precision m

Precigen's future hinges on the FDA's approval of PRGN-2012, with a pivotal decision expected August 27, 2025. PRGN-2012 shows strong efficacy and safety, potentially transforming the treatment of Recurrent Respiratory Papillomatosis and opening up a $2 billion global market opportunity. Despite promising science, Precigen has long-faced severe financial challenges and a very short cash runway into 2026.

PRGN-2012 has the potential to be the first- and best-in-class treatment for RRP Company'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, 2025 RRP is a rare, debilitating chronic disease with approximately 27,000 adult patients in the US and more than 125,000 patients outside of the US Company 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 11 Cash, cash equivalents, and investments of $81.0 million as of March 31, 2025 are anticipated to fund operations into 2026, beyond the potential 2025 commercial launch of PRGN-2012 GERMANTOWN, Md. , May 14, 2025 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve th

– 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 innovative gene and cell therapies to improve the lives of patients, today announced that the Company will team up again with the Recurrent Respiratory Papillomatosis Foundation (RRPF) to co-host the annual RRP Awareness Day on June 11, 2025.

Precigen, Inc. (NASDAQ:PGEN ) Q4 2024 Earnings Conference Call March 19, 2025 4:30 PM ET Company Participants Steven Harasym - IR Helen Sabzevari - President and CEO Rutul Shah - COO Phil Tennant - CCO Harry Thomasian - CFO Conference Call Participants Jason Butler - Citizens Carolina Ibanez Ventoso - Stifel Swayampakula Ramakanth - H.C. Wainwright Jennifer Kim - Cantor Brian Cheng - JPMorgan Operator Good evening, and welcome to the Precigen's Full Year 2024 Financial Results and Business Update Call.

Precigen, Inc. (PGEN) came out with a quarterly loss of $0.04 per share versus the Zacks Consensus Estimate of a loss of $0.06. This compares to loss of $0.09 per share a year ago.

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, 2025 Results from pivotal clinical study of PRGN-2012 were published in The Lancet Respiratory Medicine PRGN-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 cutoff Company continues to rapidly advance commercial and manufacturing readiness campaign in anticipation of 2025 commercial launch Company ended 2024 with $97.9 million in cash, cash equivalents, and investments, extending its cash runway into 2026, beyond potential 2025 commercial launch of PRGN-2012 GERMANTOWN, Md. , March 19, 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