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... Read More

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... Read More

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... Read More

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... Read More

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.... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

In June 2024 , the Company announced groundbreaking pivotal study data for PRGN-2012 gene therapy at the 2024 ASCO annual meeting in which more than half of RRP patients achieved Complete Response In July 2024 , the Company appointed Phil Tennant as Chief Commercial Officer to spearhead potential PRGN-2012 commercial launch In August 2024 , the Company announced a strategic reprioritization of its pipeline to focus on... Read More

GERMANTOWN, Md. , Aug. 9, 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 Company will release second quarter and first half 2024 financial results and provide business updates on Wednesday, August 14, 2024 . The Company will host a conference call that day at 4:30 PM ET... Read More

GERMANTOWN, Md. , Aug. 7, 2024 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN) today announced the pricing of an underwritten public offering of 35,294,118 shares of its common stock at a public offering price of $0.85 per share. Precigen has also granted the underwriters a 30-day option to purchase up to an additional 5,294,117 shares of its common stock. Gross proceeds from the offering, before deducting underwriting... Read More

GERMANTOWN, Md. , Aug. 6, 2024 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN) today announced it has commenced a $30.0 million underwritten public offering of its common stock. In addition, Precigen intends to grant the underwriters a 30-day option to purchase up to an additional $4.5 million of common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the... Read More

– PRGN-2012 is on track for a rolling BLA submission under an accelerated approval pathway; patient enrollment initiated in the confirmatory clinical trial – GERMANTOWN, Md. , Aug. 6, 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 a strategic reprioritization of the... Read More

Company strengthens focus on building and optimizing commercial readiness and pre-launch activities for PRGN-2012 in recurrent respiratory papillomatosis GERMANTOWN, Md. , July 23, 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 appointment of Phil Tennant as the... Read More

Phase 1/2 pivotal study met the primary safety and efficacy endpoints 51% (18 out of 35) of patients achieved Complete Response, requiring no surgeries after treatment with PRGN-2012; complete responses have been durable beyond 12 months with median duration of follow up of 20 months as of data cutoff 86% of patients (30 out... Read More

GERMANTOWN, Md. , May 23, 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 the Company will host a webcast on June 3, 2024 at 6:00 PM CT / 7:00 PM ET following the late-breaking oral presentation of results from the pivotal study of PRGN-2012 for the treatment of... Read More

Pivotal Phase 2 study data of PRGN-2012 for the treatment of patients with recurrent respiratory papillomatosis to be presented at the 2024 ASCO Annual Meeting as a late-breaking oral presentation on June 3 rd Company to host a conference call on June 3 rd following the PRGN-2012 ASCO presentation to discuss in detail the pivotal study results and provide business updates PRGN-2012 rolling BLA submission, under an... Read More

GERMANTOWN, Md. , May 8, 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 Company will report first quarter 2024 financial results after the market close on Tuesday, May 14, 2024 . No conference call is planned. The Company will host a conference call on Monday, June 3,... Read More

GERMANTOWN, Md. , April 24, 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 clinical data from the pivotal Phase 2 study of PRGN-2012 AdenoVerse immunotherapy for the treatment of patients with recurrent respiratory papillomatosis (RRP) will be presented in a late-breaking... Read More

Inaugural multi-stakeholder event on June 11th (6/11) will raise awareness and bring together individuals living with RRP, caregivers, clinicians, and government officials RRP is a rare, HPV-driven disease with no FDA-approved therapeutic GERMANTOWN, Md. , March 28, 2024 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve... Read More

Significant progress made in the development of the PRGN-2012 AdenoVerse immunotherapy for the treatment of RRP; Precigen plans to submit a BLA under an accelerated approval pathway in the second half of 2024; ramping up commercial readiness activities for a potential launch in 2025 Precigen's PRGN-2012 received the first Breakthrough Therapy Designation and accelerated approval pathway from the FDA for the treatment of RRP... Read More

GERMANTOWN, Md. , March 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 that Cantor Fitzgerald will be hosting a virtual fireside chat with Precigen on Monday, March 25, 2024 at 1:00 PM ET to discuss the investigational PRGN-2012 AdenoVerse ™ immunotherapy for the... Read More

GERMANTOWN, Md. , March 5, 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 Company will report fourth quarter and full year 2023 financial results on Tuesday, March 19, 2024 . The Company will host a conference call that day at 4:30 PM ET to discuss financial results and... Read More

GERMANTOWN, Md. , Feb. 6, 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 the Oppenheimer 34th Annual Healthcare Life Sciences Conference taking place virtually from February 13 to February 14, 2024.... Read More

Designation is an important step toward bringing this potentially life-changing therapy to European patients EU Orphan Drug Designation is the first regulatory designation for a gorilla adenovector based immunotherapy outside of the United States for the Company GERMANTOWN, Md. , Jan. 16, 2024 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and... Read More

PRGN-2012 Phase 2 pivotal study data in RRP is anticipated in the second quarter of 2024; the Company plans to submit a BLA under an accelerated approval pathway in the second half of 2024; commercial readiness preparations are underway for a potential launch in 2025 Company presentation scheduled for January 10 at 5:15 PM PST GERMANTOWN, Md. , Jan. 8, 2024 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical... Read More

GERMANTOWN, Md. , Dec. 18, 2023 /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 a corporate and clinical overview at the 42nd Annual J.P. Morgan Healthcare Conference on Wednesday, January 10, 2024 at 5:15 PM PT /... Read More

GERMANTOWN, Md. , Nov. 29, 2023 /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 at the JMP Securities Hematology and Oncology Summit on Wednesday, December 6, 2023 at 3:00 PM ET.... Read More

Based on FDA confirmation in August 2023 that the ongoing Phase 1/2 single-arm study of PRGN-2012 in RRP will serve as the pivotal study to support BLA submission under an accelerated approval request, the Company has expedited efforts to attain commercial readiness Full results of the Phase 1 portion of the ongoing Phase 1/2 study of PRGN-2012 were published in the peer-reviewed journal, Science Translational Medicine, and... Read More

GERMANTOWN, Md. , Nov. 7, 2023 /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 a company overview at the Stifel 2023 Healthcare Conference on Wednesday, November 15, 2023 at 10:55 AM ET in New York . Participants... Read More

GERMANTOWN, Md. , Sept. 19, 2023 /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 the following upcoming investor and industry conferences: Cantor Global Healthcare Conference 2023 Fireside chat on Tuesday,... Read More

The FDA confirmed that the ongoing Phase 1/2 single arm study of PRGN-2012 in RRP will serve as the pivotal study to support accelerated approval and no additional randomized, placebo-controlled trial will be required to support submission of a BLA Company to prioritize portfolio activities to accelerate PRGN-2012 and continue advancement of other key programs, by implementing strategies to reduce clinical costs (e.g.,... Read More

FDA confirmed that the ongoing Phase 1/2 single arm study will serve as pivotal and no additional randomized, placebo-controlled trial will be required to support submission of a BLA – FDA agreed on the required efficacy and safety endpoints that will support filing an accelerated approval BLA for licensure Enrollment and dosing in the ongoing Phase 2 portion of the study is completed If approved, PRGN-2012 would potentially... Read More

GERMANTOWN, Md. , Aug. 3, 2023 /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 second quarter and first half 2023 financial results on Wednesday, August 9, 2023 . The Company will host a conference call that day at 8:30 AM ET to discuss financial results... Read More

First FDA Breakthrough Therapy Designation granted for AdenoVerse immunotherapy platform; designation prioritizes PRGN-2012 as a potential treatment for RRP Designation based on positive Phase 1 clinical data that showed 50% of patients were "surgery-free" (Complete Response) after PRGN-2012 treatment with a minimum follow up of 12 months post-treatment GERMANTOWN, Md. , June 20, 2023 /PRNewswire/ -- Precigen, Inc. (Nasdaq:... Read More

PRGN-3005 was well-tolerated with no dose limiting toxicities, no CRS greater than Grade 2, and no neurotoxicity PRGN-3005 cells demonstrated expansion and persistence when delivered via either intraperitoneal or intravenous infusion without lymphodepletion or via intravenous infusion after lymphodepletion demonstrating the... Read More

PRGN-2009 combined with an investigational checkpoint inhibitor resulted in a 30% ORR in patients with heavily pre-treated HPV-associated cancers that were naïve or resistant to checkpoint blockade with prolonged duration of responses Recurrent/metastatic HPV-associated cancers (cervical, anal, oropharyngeal, etc.) are... Read More

HPV is responsible for more than 90 percent of cervical cancer cases globally with approximately 300,000 women living with cervical cancer in the US Current response rates to second line treatments in recurrent or metastatic cervical cancer are very low and associated with a high rate of toxicity PRGN-2009 is designed to generate de novo T-cell immune response against HPV 16/18-positive solid tumors cells and is... Read More

Positive Phase 1 clinical data presented for PRGN-2012 AdenoVerse ™ immunotherapy in RRP demonstrated favorable safety profile and significant reduction in surgeries with 50% of the patients in Complete Response following treatment with PRGN-2012 Enrollment completed in the Phase 2 study of PRGN-2012 in RRP First patient dosed in Phase 1/ 1b dose escalation/dose expansion study of PRGN-3007, a next generation UltraCAR-T ®... Read More

GERMANTOWN, Md. , May 3, 2023 /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 first quarter 2023 financial results on Wednesday, May 10, 2023 . The Company will host a conference call that day at 8:00 AM ET to discuss financial results and provide a... Read More

GERMANTOWN, Md. , April 26, 2023 /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 clinical data from the Phase 1 dose escalation study of PRGN-3005 UltraCAR-T in patients with advanced, recurrent platinum resistant ovarian cancer, and the Phase I study of PRGN-2009 AdenoVerse... Read More

First preclinical data presented for the next generation of the UltraCAR-T platform utilizing a mesothelin (MSLN) chimeric antigen receptor (CAR) MSLN is overexpressed on multiple solid tumors such as mesothelioma, ovarian cancer and pancreatic cancer Proprietary technology for checkpoint blockade intrinsic to UltraCAR-T cells has the potential for an improved safety profile and reduced cost by eliminating the need for... Read More

Precigen amends exclusive license agreement with Alaunos to bolster portfolio and broaden strategic opportunities The Company also regains exclusive rights to IL-12 gene therapy, including application through the AdenoVerse™ platform Agreement eliminates all future royalties to Alaunos Precigen to host business and clinical update call on Tuesday, April 4, 2023 at 8:30 AM ET GERMANTOWN, Md. , April 3, 2023 /PRNewswire/ --... Read More

Milestone represents the first patient dosed with the next generation UltraCAR-T, incorporating PD-1 checkpoint inhibition in addition to three effector genes Proprietary technology for checkpoint blockade intrinsic to UltraCAR-T cells avoids the need for combination with a systemic checkpoint inhibitor, potentially limiting cost and systemic toxicity GERMANTOWN, Md. , March 29, 2023 /PRNewswire/ -- Precigen, Inc. (Nasdaq:... Read More

GERMANTOWN, Md. , March 28, 2023 /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 virtual fireside chat on April 4, 2023 from 10:45 AM to 11:15 AM ET at Cantor's "The Future of Oncology" Virtual Symposium.... Read More

Achieved significant clinical progress for UltraCAR-T ® and AdenoVerse ™ investigational therapeutics in 2022 Presented positive clinical data for PRGN-2012 AdenoVerse immunotherapy in recurrent respiratory papillomatosis (RRP) showing favorable safety profile and significant reduction in surgeries with 50% of the patients in Complete Response following treatment with PRGN-2012 Presented positive clinical data for PRGN-3006... Read More

GERMANTOWN, Md. , Jan. 27, 2023 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN) announced today the closing of its previously announced underwritten public offering of common stock. Precigen sold 42,857,143 shares of its common stock at a public offering price of $1.75 per share. Gross proceeds to Precigen from the offering were approximately $75.0 million before deducting the underwriting discount and other offering expenses... Read More

GERMANTOWN, Md. , Jan. 24, 2023 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN) today announced the pricing of an underwritten public offering of 42,857,143 shares of its common stock at a public offering price of $1.75 per share. Precigen has also granted the underwriters a 30-day option to purchase up to an additional 6,428,571 shares of its common stock. Gross proceeds from the offering, before deducting underwriting... Read More

GERMANTOWN, Md. , Jan. 24, 2023 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN) today announced it has commenced an underwritten public offering of $75.0 million of its common stock. In addition, Precigen intends to grant the underwriters a 30-day option to purchase up to an additional $11.25 million of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when... Read More

Repeated administrations of PRGN-2012 were well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2 Clinical data show strong response in RRP patients with 50% of patients in Complete Response, requiring no post-treatment surgeries, following PRGN-2012 treatment at Dose Level... Read More

Company achieved significant progress for its clinical pipeline in 2022 Precigen to host R&D Day virtual event on January 24, 2023 , at 4:30 PM ET to share safety and efficacy data from the Phase 1 dose escalation and expansion cohorts of PRGN-2012 AdenoVerse™ immunotherapy in recurrent respiratory papillomatosis (RRP) GERMANTOWN, Md. , Jan. 11, 2023 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company... Read More

GERMANTOWN, Md. , Jan. 4, 2023 /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 host an investigator-led R&D event on January 24, 2023 at 4:30 PM ET to showcase the latest clinical advancements for the Company's investigational, first-in-class PRGN-2012... Read More

GERMANTOWN, Md. , Dec. 19, 2022 /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 a corporate and clinical overview at the 41st Annual J.P. Morgan Healthcare Conference on Wednesday, January 11, 2023 at 3:45 PM PT /... Read More

Single infusion of UltraCAR-T cells with or without lymphodepletion demonstrated robust expansion and persistence in blood and bone marrow PRGN-3006 infusion with lymphodepletion resulted in a decrease in bone marrow blasts in 60% of heavily pre-treated patients Single infusion of autologous PRGN-3006 cells resulted in 27%... Read More