Precigen surges on FDA approval for gene therapy
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Aug 15 2025
0mins
Should l Buy PGEN?
Source: SeekingAlpha
FDA Approval: Precigen's gene therapy candidate Papzimeos has been approved by the FDA for treating recurrent respiratory papillomatosis (RRP), leading to a ~34% increase in its shares during premarket trading.
Clinical Study Success: The approval was based on a pivotal Phase 1/2 clinical study where over 50% of patients achieved complete remission without needing surgeries within 12 months after treatment.
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Analyst Views on PGEN
Wall Street analysts forecast PGEN stock price to rise
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 3.930
Low
9.00
Averages
9.00
High
9.00
Current: 3.930
Low
9.00
Averages
9.00
High
9.00
About PGEN
Precigen, Inc. is a discovery and clinical-stage biopharmaceutical company developing gene and cell therapies for improving outcomes for patients with unmet medical needs. The Company’s proprietary technology platforms develop product candidates designed to target urgent and intractable diseases in its core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. It has developed a pipeline of therapies across multiple indications. The Company’s segments include Biopharmaceuticals and Exemplar. The Biopharmaceuticals segment is primarily comprised of the Company's legal entities as well as royalty interests in therapeutics and therapeutic platforms from companies not controlled by the Company. The Exemplar is composed of Exemplar Genetics LLC, doing business as Precigen Exemplar, its wholly owned subsidiary focused on developing research models and services for healthcare research applications.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Precigen to Participate in H.C. Wainwright Virtual Fireside Chat
- Executive Participation: Precigen's CEO Dr. Helen Sabzevari and Chief Commercial Officer Phil Tennant will participate in a virtual fireside chat with H.C. Wainwright on March 31, 2026, showcasing the company's leadership in precision medicine and likely attracting investor interest.
- Innovative Drug Development: Precigen focuses on developing innovative precision medicines for difficult-to-treat diseases, committed to scientific breakthroughs from proof-of-concept to commercialization, aiming to meet high unmet patient needs and enhance market competitiveness.
- Diverse Pipeline: The company is advancing a robust pipeline of differentiated therapies across core therapeutic areas including immuno-oncology, autoimmune disorders, and infectious diseases, demonstrating its broad positioning in the biopharmaceutical industry and potential for future growth.
- Forward-Looking Statements: Precigen's press release highlights that future commercialization efforts and clinical study successes will be subject to various risks and uncertainties, emphasizing the challenges the company faces in achieving its financial and operational goals.
See More
Precigen to Participate in Virtual Fireside Chat
- Executive Participation: Precigen's CEO Dr. Helen Sabzevari and Chief Commercial Officer Phil Tennant will participate in a virtual fireside chat with H.C. Wainwright on March 31, 2026, showcasing the company's leadership in precision medicine.
- Innovative Drug Development: Precigen focuses on developing innovative precision medicines for difficult-to-treat diseases, demonstrating its strong capabilities in the biopharmaceutical industry from proof-of-concept to commercialization.
- Diverse Therapeutic Pipeline: The company is advancing a robust pipeline of differentiated therapies across immuno-oncology, autoimmune disorders, and infectious diseases, highlighting its strategic importance in addressing high unmet patient needs.
- Forward-Looking Statements: Precigen's statements indicate that future commercialization efforts and clinical studies will face various risks and uncertainties, emphasizing the challenges the company faces in achieving its financial and operational goals.
See More
Precigen Shares Surge 30% on Positive Q1 Revenue Outlook Despite Lower Financials
- Financial Overview: Precigen reported Q4 revenue of $9.7 million, missing market expectations by $3.8 million, although product revenue from Papzimeos reached $3.4 million, indicating the new therapy's market potential.
- Widened Net Loss: The company's net loss per share widened approximately 191% year-over-year to $1.37, primarily due to a 70% year-over-year surge in selling and administrative expenses to $70.1 million, including $27.3 million related to the Papzimeos launch.
- Optimistic Revenue Forecast: CEO Helen Sabzevari projected Q1 revenue could exceed $18 million, surpassing Bloomberg's consensus of $14.1 million, reflecting strong demand from patients and physicians for Papzimeos.
- Analyst Rating Upgrades: H.C. Wainwright analyst raised the price target from $9 to $10, believing Papzimeos has the potential to become a franchise product, demonstrating market confidence in its future growth.
See More
Precigen Inc Reports Strong Revenue Growth and Challenges in 2025 Earnings
- Significant Revenue Growth: Precigen Inc reported a net product revenue of $3.4 million in Q4 2025, with full-year revenue reaching $9.7 million, a 149% increase year-over-year, and expects Q1 2026 revenue to exceed $18 million, indicating a successful transition from R&D to commercialization.
- FDA Approval of New Drug: The company’s PAPZIMEOS received full FDA approval for adult recurrent respiratory papillomatosis, reflecting unmatched efficacy and strong clinical data, which is expected to further drive revenue growth and expand market share.
- Expense Structure Changes: While research and development expenses decreased by $11.7 million (22.1%) from 2024, selling, general, and administrative expenses increased by $28.8 million (69.8%), primarily due to costs associated with PAPZIMEOS commercial activities, potentially impacting future profitability.
- Patient Conversion Challenges: The company faces challenges in converting 300 patients from the support hub to receiving reimbursed treatment; although the J-code simplifies the process, the speed of conversion varies by institution, which may affect the sustainability of revenue.
See More
Precigen Q4 2025 Earnings Call Highlights
- Revenue Growth: Precigen reported $3.4 million in product revenue for Q4 2025, with shipments starting in November, and expects Q1 2026 revenues to exceed $18 million, indicating strong market demand and product acceptance.
- Broad Payer Coverage: As of early January, Precigen's payer coverage increased from approximately 170 million to 215 million lives, encompassing nearly all major commercial, Medicare, and Medicaid payers, enhancing the product's market penetration capabilities.
- Significant Financial Improvement: Total revenue for 2025 reached $9.7 million, a 149% increase from 2024, despite a net loss of $429.6 million; however, management anticipates achieving cash flow breakeven by the end of 2026, indicating progress towards profitability.
- Clinical Trials and Expansion Plans: Management announced plans to initiate a PAPZIMEOS clinical trial for pediatric RRP in Q4 2026 and is pursuing EMA marketing authorization, demonstrating the company's strategic focus on new markets and indications.
See More
Precigen (PGEN) Q4 2025 Earnings Call Transcript
See More
Precigen to Participate in H.C. Wainwright Virtual Fireside Chat
- Executive Participation: Precigen's CEO Dr. Helen Sabzevari and Chief Commercial Officer Phil Tennant will participate in a virtual fireside chat with H.C. Wainwright on March 31, 2026, showcasing the company's leadership in precision medicine and likely attracting investor interest.
- Innovative Drug Development: Precigen focuses on developing innovative precision medicines for difficult-to-treat diseases, committed to scientific breakthroughs from proof-of-concept to commercialization, aiming to meet high unmet patient needs and enhance market competitiveness.
- Diverse Pipeline: The company is advancing a robust pipeline of differentiated therapies across core therapeutic areas including immuno-oncology, autoimmune disorders, and infectious diseases, demonstrating its broad positioning in the biopharmaceutical industry and potential for future growth.
- Forward-Looking Statements: Precigen's press release highlights that future commercialization efforts and clinical study successes will be subject to various risks and uncertainties, emphasizing the challenges the company faces in achieving its financial and operational goals.
See More
Precigen to Participate in Virtual Fireside Chat
- Executive Participation: Precigen's CEO Dr. Helen Sabzevari and Chief Commercial Officer Phil Tennant will participate in a virtual fireside chat with H.C. Wainwright on March 31, 2026, showcasing the company's leadership in precision medicine.
- Innovative Drug Development: Precigen focuses on developing innovative precision medicines for difficult-to-treat diseases, demonstrating its strong capabilities in the biopharmaceutical industry from proof-of-concept to commercialization.
- Diverse Therapeutic Pipeline: The company is advancing a robust pipeline of differentiated therapies across immuno-oncology, autoimmune disorders, and infectious diseases, highlighting its strategic importance in addressing high unmet patient needs.
- Forward-Looking Statements: Precigen's statements indicate that future commercialization efforts and clinical studies will face various risks and uncertainties, emphasizing the challenges the company faces in achieving its financial and operational goals.
See More
Precigen Shares Surge 30% on Positive Q1 Revenue Outlook Despite Lower Financials
- Financial Overview: Precigen reported Q4 revenue of $9.7 million, missing market expectations by $3.8 million, although product revenue from Papzimeos reached $3.4 million, indicating the new therapy's market potential.
- Widened Net Loss: The company's net loss per share widened approximately 191% year-over-year to $1.37, primarily due to a 70% year-over-year surge in selling and administrative expenses to $70.1 million, including $27.3 million related to the Papzimeos launch.
- Optimistic Revenue Forecast: CEO Helen Sabzevari projected Q1 revenue could exceed $18 million, surpassing Bloomberg's consensus of $14.1 million, reflecting strong demand from patients and physicians for Papzimeos.
- Analyst Rating Upgrades: H.C. Wainwright analyst raised the price target from $9 to $10, believing Papzimeos has the potential to become a franchise product, demonstrating market confidence in its future growth.
See More
Precigen Inc Reports Strong Revenue Growth and Challenges in 2025 Earnings
- Significant Revenue Growth: Precigen Inc reported a net product revenue of $3.4 million in Q4 2025, with full-year revenue reaching $9.7 million, a 149% increase year-over-year, and expects Q1 2026 revenue to exceed $18 million, indicating a successful transition from R&D to commercialization.
- FDA Approval of New Drug: The company’s PAPZIMEOS received full FDA approval for adult recurrent respiratory papillomatosis, reflecting unmatched efficacy and strong clinical data, which is expected to further drive revenue growth and expand market share.
- Expense Structure Changes: While research and development expenses decreased by $11.7 million (22.1%) from 2024, selling, general, and administrative expenses increased by $28.8 million (69.8%), primarily due to costs associated with PAPZIMEOS commercial activities, potentially impacting future profitability.
- Patient Conversion Challenges: The company faces challenges in converting 300 patients from the support hub to receiving reimbursed treatment; although the J-code simplifies the process, the speed of conversion varies by institution, which may affect the sustainability of revenue.
See More
Precigen Q4 2025 Earnings Call Highlights
- Revenue Growth: Precigen reported $3.4 million in product revenue for Q4 2025, with shipments starting in November, and expects Q1 2026 revenues to exceed $18 million, indicating strong market demand and product acceptance.
- Broad Payer Coverage: As of early January, Precigen's payer coverage increased from approximately 170 million to 215 million lives, encompassing nearly all major commercial, Medicare, and Medicaid payers, enhancing the product's market penetration capabilities.
- Significant Financial Improvement: Total revenue for 2025 reached $9.7 million, a 149% increase from 2024, despite a net loss of $429.6 million; however, management anticipates achieving cash flow breakeven by the end of 2026, indicating progress towards profitability.
- Clinical Trials and Expansion Plans: Management announced plans to initiate a PAPZIMEOS clinical trial for pediatric RRP in Q4 2026 and is pursuing EMA marketing authorization, demonstrating the company's strategic focus on new markets and indications.
See More
Precigen (PGEN) Q4 2025 Earnings Call Transcript
See More
