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 (Nasdaq: PGEN) will host a virtual event on November 4, 2021, at 11:00 AM ET to discuss updates on its clinical pipeline. The event will present data on several advanced programs, including PRGN-3005 and PRGN-3006 UltraCAR-T, as well as PRGN-2009 and PRGN-2012 AdenoVerse Immunotherapies. Executives and lead investigators from notable institutions will participate. Details for registration and access to the live webcast are available on Precigen's investor relations website.
Precigen has announced that the FDA has cleared its IND application to launch a Phase 1/1b clinical trial for PRGN-3007, targeting advanced ROR1+ hematological and solid tumors. This first-in-class therapy, leveraging Precigen's UltraCAR-T® platform, aims to improve outcomes in patients with cancers like CLL and TNBC by incorporating PD-1 blockade. The trial will assess safety and efficacy in two arms: one for hematological tumors and another for solid tumors. This innovative therapy is expected to mitigate systemic toxicity and reduce treatment costs.
Precigen, Inc. (Nasdaq: PGEN) announced the appointment of Harry Thomasian Jr. as its new chief financial officer (CFO), effective October 18, 2021. With over 35 years of global finance experience, Thomasian will oversee corporate financial strategy, business development, and financing initiatives. Prior to joining Precigen, he held leadership roles at EY, focusing on the life sciences sector. CEO Helen Sabzevari emphasized Thomasian's financial acumen and experience as vital for guiding the company's growth and fiscal strength.
Precigen ActoBio announced encouraging interim data from its Phase 1b/2a clinical study of AG019 ActoBiotics for recent-onset type 1 diabetes. Presenting at the EASD 57th Annual Meeting, results demonstrated AG019’s safety and efficacy, with 100% of adult patients achieving glycated hemoglobin below 7% after monotherapy. The study met primary endpoints; no serious adverse events occurred. AG019 also stabilized C-peptide levels, indicating preserved insulin production. Future investigations will explore AG019's potential as a standalone therapy for type 1 diabetes.
Precigen, Inc. (Nasdaq: PGEN) announced that Dr. Helen Sabzevari will participate in two key conferences. She will engage in a virtual fireside chat at the Wells Fargo Virtual Healthcare Conference on September 9, 2021, at 8:40 AM ET. Additionally, she will present at the H.C. Wainwright 23rd Annual Global Investment Conference, with the webcast available on-demand starting September 13, 2021, at 7:00 AM ET. Webcast access is available via Precigen's website.
Precigen, Inc. (Nasdaq: PGEN) reported its second quarter and first half 2021 financial results, highlighting a total revenue increase of 10% year-over-year for Q2. However, net loss from continuing operations was $20.1 million, equivalent to $(0.10) per share. The company is advancing its clinical pipeline, with ongoing trials for PRGN-3005 and PRGN-3006 UltraCAR-T therapies and PRGN-2009 AdenoVerse immunotherapy. Precigen anticipates interim data presentations in Q4 2021, indicating a pivotal year for its innovative therapies.
Precigen, a biopharmaceutical company focused on gene and cell therapies, will release its second quarter and first half 2021 financial results after market close on August 9, 2021. A conference call will be held at 4:05 PM ET on the same day to discuss the results and provide a business update. Investors can access the call by dialing specific numbers or register through the company's website. Precigen emphasizes its commitment to innovative therapies targeting critical diseases, enhancing its pipeline direction toward clinical proof-of-concept.
Precigen ActoBio announced positive topline results from its ongoing Phase 1b/2a clinical study of AG019 ActoBiotics for treating recent-onset type 1 diabetes (T1D). The treatment targets autoimmune responses by delivering human proinsulin and interleukin-10 to induce regulatory T cells. Results show that 56% of adult patients receiving AG019 monotherapy stabilized or increased C-peptide levels. In combination therapy with teplizumab, 70% of adults and 100% of adolescents had similar results. The therapy appears safe, with no serious adverse events reported, paving the way for future studies.
Precigen, Inc. (Nasdaq: PGEN) announced that Dr. Helen Sabzevari, President and CEO, will participate in a fireside chat at the JMP Securities Life Sciences Conference on June 17, 2021, at 11:00 AM ET. The event will be accessible through Precigen's website in the Events & Presentations section. The company focuses on innovative gene and cell therapies targeting urgent diseases in immuno-oncology, autoimmune disorders, and infectious diseases. Precigen aims to advance affordable biotherapeutics and has a robust pipeline moving toward clinical proof-of-concept.
Precigen, Inc. (Nasdaq: PGEN) reported its Q1 2021 financial results, highlighting significant advancements in its clinical trials. The UltraCAR-T therapies, PRGN-3005 and PRGN-3006, showcased promising safety profiles and clinical activities, with ongoing dose escalation phases. The company initiated the PRGN-2012 study, received orphan drug designations for multiple therapies, and anticipates upcoming data presentations. Financially, total revenues fell by 18% to $24.5 million, attributed mainly to decreased collaboration revenues. However, total cash on hand stands at $209.3 million.