Precigen, Inc. is a biotechnology company, which engages in the research and development of synthetic biology technologies. It operates through the following segments: Biopharmaceuticals, Exemplar, and Trans Ova. The Biopharmaceuticals segment is involved in advancing the next generation of gene and cell therapies using precision technology to target urgent and intractable diseases in immuno-oncology, autoimmune disorders, and infectious diseases. It also engages in pioneering a proprietary class of microbe-based biopharmaceuticals that enable expression and local delivery of disease-modifying therapeutics. The Exemplar segment is focused on developing research models and services for healthcare research applications. The Trans Ova segment provides bovine reproductive technologies. The company was founded by Thomas David Reed in 1998 and is headquartered in Germantown, MD.
相关临床试验
5
3 进行中
药物批准
1
批准总数
监管机构
1
监管机构数
成立时间
1998
进行中（未招募）
3
60.0%
招募中
2
40.0%
- Precigen CFO Harry Thomasian Jr. sold 200,000 shares for approximately $1.1 million under a pre-arranged Rule 10b5-1 trading plan between June 29 and July 1, 2026. - The sale reduced Thomasian's direct holdings by 36.07%, with 354,535 shares remaining, and was executed at a weighted average price of $5.57 per share. - Precigen shares reached a multi-year high of $6.04 on June 29, driven by strong Q1 revenue of $23.3 million, up from $1.3 million in the prior year. - The FDA granted orphan drug designation to Precigen's Papzimeos for recurrent respiratory papillomatosis, providing market exclusivity through August 2032.
- Precigen received FDA approval for Papzimeos, the first and only treatment for recurrent respiratory papillomatosis, a rare disease affecting an estimated 27,000 patients in the US. - In clinical trials, 18 out of 35 patients treated with Papzimeos avoided tumor removal surgery for at least 12 months, with 15 patients remaining surgery-free at 24 months. - The cell-based immunotherapy is priced above $200,000 per patient annually and could generate over $1 billion in peak annual sales. - Precigen's stock surged 155% following the approval, with analysts maintaining positive outlooks despite the company's current $1.3 billion market cap.
- Precigen announced a $125 million credit facility with Pharmakon Advisors, with $100 million funded at closing to support commercialization of PAPZIMEOS immunotherapy. - The financing will enable robust US commercialization of PAPZIMEOS for recurrent respiratory papillomatosis while supporting international expansion and pediatric indications. - The credit facility includes a second tranche of $25 million available through March 2027, positioning Precigen for significant growth as it transitions to a commercial company.
- The FDA has approved zopapogene imadenovec-drba (Papzimeos) as the first non-replicating adenoviral vector-based immunotherapy for treating adult patients with recurrent respiratory papillomatosis. - In a pivotal Phase 1/2 trial, 51% of patients achieved complete response and at least 85% experienced decreased surgical intervention one year after treatment completion. - The approval represents a potential transformation for RRP treatment, offering lasting relief for patients who previously required repeated surgeries throughout their lifetime. - The therapy demonstrated a well-tolerated safety profile with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2.
- The FDA has accepted Precigen's Biologics License Application for PRGN-2012 with priority review, setting a PDUFA target action date of August 27, 2025 for the potential first-ever approved therapy for recurrent respiratory papillomatosis. - PRGN-2012, an AdenoVerse gene therapy, demonstrated remarkable efficacy in clinical trials with over 50% of patients achieving complete response and more than 85% experiencing reduced surgical interventions, addressing a significant unmet need. - If approved, PRGN-2012 would transform treatment for approximately 27,000 adult RRP patients in the US who currently rely on repeated surgeries that don't address the underlying HPV 6/11 infection.
- Precigen is set to submit a rolling BLA for PRGN-2012 in recurrent respiratory papillomatosis (RRP) in Q4 2024 under an accelerated approval pathway. - The company's pivotal study showed that 51% of RRP patients achieved complete response with PRGN-2012, requiring no surgeries post-treatment. - Preclinical data presented at SITC 2024 highlights PRGN-3008, a next-generation UltraCAR-T targeting CD19, with potential for oncology and autoimmune diseases. - Precigen is preparing for an end-of-Phase 1b meeting with the FDA in early 2025 for PRGN-3006 in acute myeloid leukemia (AML).
- Precigen completed a pre-BLA meeting with the FDA, achieving full alignment on the BLA content for PRGN-2012, targeting a rolling submission in Q4 2024. - Commercial and manufacturing readiness campaigns are underway for PRGN-2012, anticipating a potential launch in 2025 for recurrent respiratory papillomatosis. - A confirmatory clinical trial for PRGN-2012 has been initiated, following FDA guidance, with ongoing patient enrollment to support the BLA submission. - Preclinical data presented at SITC 2024 highlights PRGN-3008, a next-generation UltraCAR-T therapy targeting CD19, showing promise as a best-in-class treatment for oncology and autoimmunity.
- Precigen's Papzimeos (zopapogene imadenovec-drba) becomes the first and only FDA-approved treatment for adults with recurrent respiratory papillomatosis (RRP), a rare HPV-related airway condition. - The gene therapy demonstrated a 51% complete response rate in a pivotal phase I/II study, with 18 of 35 patients eliminating the need for surgeries in the 12 months following treatment. - The FDA granted full approval rather than accelerated approval, meaning Precigen will not need to conduct confirmatory studies for the RRP indication. - Approximately 27,000 adult patients in the United States suffer from RRP, which causes benign tumors to grow in the respiratory tract and typically requires frequent surgeries.
