Welcome to our dedicated page for Precigen news (Ticker: PGEN), a resource for investors and traders seeking the latest updates and insights on Precigen stock.
Precigen, Inc. (Nasdaq: PGEN) is a biopharmaceutical company focused on precision medicines, and its news flow reflects the transition from a clinical-stage organization to a commercial-stage company. Recent announcements highlight full FDA approval and commercial launch of PAPZIMEOS (zopapogene imadenovec-drba), which the company describes as the first and only FDA-approved therapy for adults with recurrent respiratory papillomatosis (RRP). News items detail how PAPZIMEOS was discovered and designed using Precigen’s AdenoVerse platform and how it is being prescribed nationwide in the United States.
Investors and observers following PGEN news will see updates on PAPZIMEOS commercialization, including patient hub enrollment, payer coverage across private health plans and government programs, manufacturing and supply chain arrangements, and engagement with major medical centers and community practices. The company also issues news on long-term clinical data for PAPZIMEOS, emphasizing durable complete responses, reductions in surgery rates, and safety outcomes presented at medical meetings and in peer-reviewed publications.
Beyond PAPZIMEOS, Precigen’s news coverage includes pipeline developments such as progress in Phase 2 trials for PRGN-2009 in HPV-associated cancers and updates on PRGN-3006, an investigational UltraCAR-T therapy for acute myeloid leukemia and myelodysplastic syndromes. Financial results releases and related press statements provide context on capital resources, non-dilutive financing arrangements, preferred stock transactions, and the company’s expectations regarding funding operations through a projected cash flow break-even point.
Visitors to the PGEN news page can expect regular disclosures on regulatory milestones, conference presentations, investor webcasts, and business updates that illustrate how Precigen is advancing its precision medicine strategy and commercial execution around PAPZIMEOS and its broader pipeline.
Precigen announced new data from its PRGN-3006 UltraCAR-T® phase 1/1b study for treating relapsed or refractory acute myeloid leukemia (AML) at the 62nd ASH Annual Meeting. The study shows promising results, with six patients treated and no dose-limiting toxicities reported. A 100% manufacturing success rate using their proprietary process was achieved. The UltraCAR-T cells demonstrated encouraging expansion and persistence in patients, with one case study showing robust cell activity seven months post-infusion. These advancements suggest a potential improvement over existing CAR-T therapies.
On November 16, 2020, Precigen (Nasdaq: PGEN) announced the successful dosing of the first patients with UltraCAR-T cells made using its proprietary UltraPorator system, which aims to revolutionize the manufacturing of personalized cancer therapies. The patients participated in two Phase 1 clinical trials: PRGN-3005 for advanced ovarian cancer and PRGN-3006 for relapsed acute myeloid leukemia. This innovation streamlines manufacturing, allowing for rapid cell production within medical facilities and timely patient treatment.
Precigen, Inc. (Nasdaq: PGEN) reported third quarter 2020 revenues of $23.6 million, up 29% from $18.3 million in Q3 2019. The net loss narrowed to $29.5 million or $(0.18) per share, improving from $49.1 million or $(0.32) per share a year prior. Year-to-date revenues reached $83.8 million, a 14% increase from $73.7 million in 2019. Key achievements included FDA clearance for the UltraPorator system, dosing the first patient in the PRGN-2009 trial, and advancing UltraCAR-T therapies for ovarian cancer and AML.
Precigen, a biopharmaceutical company, will release its third quarter 2020 financial results on November 9, 2020. The company focuses on developing gene and cell therapies for various diseases, including cancer and autoimmune disorders. In early December, Precigen plans to host a call to update stakeholders on its clinical pipeline. The firm emphasizes its commitment to precision medicine and aims to innovate in affordable biotherapeutics. Investors should stay tuned for financial performance insights and clinical progress in the upcoming announcements.
Precigen, Inc. (Nasdaq: PGEN) has appointed Gaurav Vij as the new head of business development. Mr. Vij, with over 18 years of experience, will focus on accelerating strategic partnerships and enhancing the company’s pipeline programs. His prior experience includes significant roles at Gilead Sciences, Amgen, and Shire Pharmaceuticals, with a strong emphasis on oncology. This appointment aligns with Precigen's strategy to maximize value through partnerships and foster innovation in gene and cell therapies.
Precigen (Nasdaq: PGEN) has received FDA clearance for its UltraPorator system, designed for rapid manufacturing of UltraCAR-T therapies. This system enables efficient clinical trial manufacturing for PRGN-3005 and PRGN-3006, targeting ovarian cancer and acute myeloid leukemia, respectively. The technology transfer is now complete, allowing personalized therapy delivery to patients. The UltraPorator significantly reduces processing time and contamination risks compared to traditional methods, enhancing the scalability of CAR-T therapy production. This advancement aims to transform patient access to critical cancer treatments.
On October 9, 2020, Precigen (Nasdaq: PGEN) announced that Merck KGaA, Darmstadt, Germany, increased its ownership from 11.6% to 14.8% by converting a $25 million convertible note. This move positions Merck as Precigen's second-largest shareholder. The agreement includes the reassignment of CAR-T development rights, allowing Precigen to regain autonomy over its proprietary CAR-T technology in exchange for $150 million in stock and the convertible note. Two UltraCAR-T therapies are currently in Phase 1 trials against ovarian cancer and AML.
On September 8, 2020, Precigen (Nasdaq: PGEN) announced that Helen Sabzevari, PhD, President and CEO, will present at the H.C. Wainwright 22nd Annual Global Investment Conference on September 14, 2020, at 10:30 AM ET. The event will be accessible via a live webcast through Precigen’s website. Precigen focuses on innovative gene and cell therapies to address serious diseases in immuno-oncology, autoimmune disorders, and infectious diseases, advancing its clinical pipeline toward commercialization.
Precigen, Inc. (Nasdaq: PGEN) announced the first patient has been dosed with PRGN-2009, an investigational OTS immunotherapy targeting HPV-associated solid tumors. The Phase I trial will evaluate the safety of PRGN-2009 as a monotherapy and in combination with bintrafusp alfa for recurrent or metastatic cancers. The study, facilitated through a CRADA with the National Cancer Institute, marks a significant step in developing new treatment options for patients. HPV-related cancers account for approximately 44,000 cases annually in the U.S., emphasizing the importance of this research.
Precigen, Inc. (PGEN) released its second quarter and first half financial results for 2020, reporting total revenues of $30.4 million for Q2 and $60.3 million for the first half. The net loss was $43.4 million in Q2 ($0.26 per share) and $73.3 million in the first half ($0.45 per share), affected by non-cash charges. Key developments included advancements in the UltraPorator device and ongoing clinical trials for therapies like UltraCAR-T and AG019, demonstrating promising safety and efficacy results.