| Precigen Reports First Quarter 2025 Financial Results and Business Updates |
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 the lives of patients, today announced first quarter 2025 financial results and business updates. |
prnewswire.com |
2025-05-14 20:05:00 |
Czytaj oryginał (ang.) |
| Precigen and Recurrent Respiratory Papillomatosis Foundation to Host the 2025 International RRP Awareness Day on June 11th |
– 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. |
prnewswire.com |
2025-04-16 12:05:00 |
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| Precigen, Inc. (PGEN) Q4 2024 Earnings Call Transcript |
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. |
seekingalpha.com |
2025-03-19 21:47:24 |
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| Precigen, Inc. (PGEN) Reports Q4 Loss, Lags Revenue Estimates |
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. |
zacks.com |
2025-03-19 21:25:21 |
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| Precigen Reports Full Year 2024 Financial Results and Business Updates |
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 announced full year 2024 financial results and business updates. |
prnewswire.com |
2025-03-19 18:05:00 |
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| Precigen to Announce Full Year 2024 Financial Results and Provide Business Updates on March 19th |
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. |
prnewswire.com |
2025-03-13 10:05:00 |
Czytaj oryginał (ang.) |
| Precigen: UltraCAR-T Development Brings Another Side Of Pipeline Advancement |
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. |
seekingalpha.com |
2025-02-28 10:56:12 |
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| FDA Grants Priority Review to Precigen's BLA for PRGN-2012 for the Treatment of Adults with Recurrent Respiratory Papillomatosis with PDUFA Target Action Date Set for August 27, 2025 |
– 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) has accepted the company's biologics license application (BLA) for PRGN-2012 (nonproprietary name: zopapogene imadenovec † ), an investigational AdenoVerse ® gene therapy for the treatment of adults with recurrent respiratory papillomatosis (RRP). |
prnewswire.com |
2025-02-25 10:05:00 |
Czytaj oryginał (ang.) |
| Precigen, Inc. (PGEN) Just Flashed Golden Cross Signal: Do You Buy? |
Precigen, Inc. (PGEN) is looking like an interesting pick from a technical perspective, as the company reached a key level of support. Recently, PGEN's 50-day simple moving average crossed above its 200-day simple moving average, known as a "golden cross. |
zacks.com |
2025-02-20 12:55:34 |
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| Precigen to Present Plans for Realizing Commercial Vision for PRGN-2012 at the 43rd Annual J.P. Morgan Healthcare Conference |
– 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. |
prnewswire.com |
2025-01-13 09:00:00 |
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| Precigen to Present at the 43rd Annual J.P. Morgan Healthcare Conference |
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. |
prnewswire.com |
2025-01-09 10:30:00 |
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| PGEN Stock Surges More Than 40% in a Week: What's Driving the Rally? |
The upside in Precigen's stock comes after it completes the rolling submission of an FDA filing for its first potentially marketed product. |
zacks.com |
2025-01-02 16:34:28 |
Czytaj oryginał (ang.) |
| Precigen Completes Submission of BLA with Request for Priority Review to the FDA for PRGN-2012 for the Treatment of Adults with Recurrent Respiratory Papillomatosis |
– 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). |
prnewswire.com |
2024-12-30 09:00:00 |
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| Precigen Announces $79.0 Million Private Placement Offering of Convertible Preferred Stock |
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. |
prnewswire.com |
2024-12-27 11:00:00 |
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| Precigen, Inc. (PGEN) Reports Q3 Loss, Lags Revenue Estimates |
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. |
zacks.com |
2024-11-14 20:45:34 |
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| Precigen Reports Third Quarter 2024 Financial Results and Business Updates |
– 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. |
prnewswire.com |
2024-11-14 18:30:00 |
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| Precigen to Participate in the Stifel 2024 Healthcare Conference |
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. |
prnewswire.com |
2024-11-12 18:05:00 |
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| Precigen to Participate in the 2024 Cantor Global Healthcare Conference |
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. |
prnewswire.com |
2024-09-16 20:30:00 |
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| 3 Penny Stocks To Buy With Just $50 |
Penny stocks are an interesting category. While they have the potential to produce significant long-run gains, you should never bet money on these stocks that you can't afford to lose. |
247wallst.com |
2024-09-15 11:54:35 |
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| 3 Penny Stocks to Buy With $500 |
Are you interested in investing in penny stocks? |
247wallst.com |
2024-08-30 14:20:24 |
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| Titan Machinery Reports Weak Preliminary Results, Joins Precigen, Gogoro And Other Big Stocks Moving Lower In Thursday Pre-Market Session |
U.S. stock futures were higher this morning, with the Dow futures gaining around 0.2% on Thursday. |
benzinga.com |
2024-08-15 12:11:53 |
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| Precigen, Inc. (PGEN) Q2 2024 Earnings Call Transcript |
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. |
seekingalpha.com |
2024-08-14 23:03:08 |
Czytaj oryginał (ang.) |
| Precigen, Inc. (PGEN) Reports Q2 Loss, Misses Revenue Estimates |
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. |
zacks.com |
2024-08-14 22:31:04 |
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| Precigen Reports Second Quarter and First Half 2024 Financial Results and Business Updates |
– 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 advancement of its lead program, PRGN-2012 in RRP – – PRGN-2012 rolling BLA submission, under an accelerated approval pathway, is anticipated in the second half of 2024; the Company has initiated enrollment in the confirmatory clinical trial of PRGN-2012 – – In August 2024, the Company strengthened its cash position by raising approximately $31.4 million via a public offering of common stoc k – GERMANTOWN, Md. , Aug. 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 second quarter and first half 2024 financial results and business updates. |
prnewswire.com |
2024-08-14 20:05:00 |
Czytaj oryginał (ang.) |
| Precigen to Announce Second Quarter and First Half 2024 Financial Results on August 14th |
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. |
prnewswire.com |
2024-08-09 12:00:00 |
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| Precigen Announces Pricing of $30.0 Million Public Offering of Common Stock |
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. |
prnewswire.com |
2024-08-08 01:30:00 |
Czytaj oryginał (ang.) |
| Earnings Preview: Precigen, Inc. (PGEN) Q2 Earnings Expected to Decline |
Precigen (PGEN) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations. |
zacks.com |
2024-08-07 15:06:22 |
Czytaj oryginał (ang.) |
| Precigen Announces Proposed $30 Million Public Offering of Common Stock |
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. |
prnewswire.com |
2024-08-06 20:04:00 |
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| Precigen Strategically Prioritizes Portfolio to Focus on First Potential Gene Therapy Launch |
– 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 Company's clinical portfolio and streamlining of resources, including a reduction of over 20% of its workforce, to focus on potential commercialization of the PRGN-2012 AdenoVerse ® gene therapy for the treatment of recurrent respiratory papillomatosis (RRP). |
prnewswire.com |
2024-08-06 20:01:00 |
Czytaj oryginał (ang.) |
| Precigen Appoints Phil Tennant as Chief Commercial Officer to Spearhead First Potential Gene Therapy Launch |
– 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 Company's chief commercial officer. |
prnewswire.com |
2024-07-23 12:01:00 |
Czytaj oryginał (ang.) |
| Precigen Announces Groundbreaking Pivotal Study Data for PRGN-2012 in Patients with Recurrent Respiratory Papillomatosis in Which More than Half of Patients Achieved Complete Response |
– 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 of 35) had a decrease in surgical interventions in the year after PRGN-2012 treatment compared to the year prior to treatment; RRP surgeries reduced from a median of 4 pre-treatment to 0 post-treatment – – PRGN-2012 was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2 – – PRGN-2012 treatment induced HPV 6/11-specific T cell responses in RRP patients with a significantly greater expansion of peripheral HPV-specific T cells in responders compared with non-responders – – PRGN-2012 significantly (p < 0.0001) improved Derkay and quality of life scores in complete responders – – RRP is a rare, devastating HPV-mediated chronic disease characterized by growth of benign tumors for which the current standard-of-care is repeated surgeries ; if approved, PRGN-2012 has the potential to be the first FDA-approved therapeutic for the treatment of RRP – – Clinical data associated with favorable safety, strong efficacy, ease of administration, and immunological responses, position PRGN-2012 to potentially be the preferred treatment-of-choice for RRP – – PRGN-2012 rolling BLA submission, under an accelerated approval pathway, is anticipated in the second half of 2024 – – Precigen to host webcast event today at 6:00 PM CT / 7:00 PM ET – GERMANTOWN, Md. , June 3, 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 released positive Phase 1/2 pivotal study results for the investigational PRGN-2012 off-the-shelf (OTS) AdenoVerse ® gene therapy in patients with recurrent respiratory papillomatosis (RRP). |
prnewswire.com |
2024-06-03 13:30:00 |
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