Precigen (PGEN) News & Sentiment

BLA of PRGN-2012 for patients with Recurrent Respiratory Papillomatosis was accepted by FDA with a Priority Review date of August 27th of 2025. Marketing approval of PRGN-2012 for RRP would be huge because there is no FDA approved drugs for RRP. Also, there are an estimated 27,000 people in the United States who have it. PGEN is looking to form a strategic partnership or collaboration agreement to advance its UltraCAR-Ts. This technology is crucial because it could change CAR-T landscape for the better.

–   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 AdenoVerse platform in other HPV6/11-driven indications, such as genital warts, which has significant unmet need with annual global incidence of more than 4 million and prevalence of more than 25 million, and HPV16/18-driven indications, such as cervical cancer and head and neck cancers  – –   Company presentation on Thursday, January 16, 2025 at 9:00 AM PT in San Francisco – GERMANTOWN, Md. , Jan. 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 highlights for the upcoming company presentation at the 43rd Annual J.P.

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.

The upside in Precigen's stock comes after it completes the rolling submission of an FDA filing for its first potentially marketed product.

–   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-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2 – GERMANTOWN, Md. , Dec. 30, 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 the completion of the rolling submission for a biologics license application (BLA) to the US Food and Drug Administration (FDA) for PRGN-2012 (INN: zopapogene imadenovec † ) for the treatment of adult patients with recurrent respiratory papillomatosis (RRP).

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, Inc. (PGEN) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of a loss of $0.08. This compares to loss of $0.08 per share a year ago.

–   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 showcasing potential to be best-in-class CD19-targeting CAR-T treatment in oncology and autoimmunity – GERMANTOWN, Md. , Nov. 14, 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 third quarter 2024 financial results and business updates.

GERMANTOWN, Md. , Nov. 12, 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 Helen Sabzevari, PhD, President and CEO of Precigen, will participate in a fireside chat on Tuesday, November 19, 2024 from 10:55 to 11:25 AM ET at the Stifel 2024 Healthcare Conference taking place November 18 to 19, 2024 in New York.