Precigen (PGEN) Stock

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.

GERMANTOWN, Md. , Sept. 16, 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 Helen Sabzevari, PhD, President and CEO of Precigen, will participate in a fireside chat on Wednesday, September 18, 2024 from 9:45 to 10:15 AM ET at the 2024 Cantor Global Healthcare Conference taking place September 17 to 19, 2024 in New York.

Precigen, Inc. (NASDAQ:PGEN ) Q2 2024 Earnings Conference Call August 14, 2024 4:30 PM ET Company Participants Steven Harasym - VP, IR Helen Sabzevari - President & CEO Harry Thomasian - CFO Phil Tennant - Chief Commercial Officer Rutul Shah - COO Conference Call Participants Carolina Ibanez Ventoso - Stifel Jason Butler - Citizens JMP Swayampakula Ramakanth - H.C. Wainwright Jennifer Kim - Cantor Fitzgerald Operator Good evening and welcome to the Precigen's Second Quarter and First Half 2024 Financial Results Call.

Precigen, Inc. (PGEN) came out with a quarterly loss of $0.10 per share versus the Zacks Consensus Estimate of a loss of $0.09. This compares to loss of $0.08 per share a year ago.