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.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy PGEN?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on PGEN
Wall Street analysts forecast PGEN stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for PGEN is 9.00 USD with a low forecast of 9.00 USD and a high forecast of 9.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 4.240
Low
9.00
Averages
9.00
High
9.00
Current: 4.240
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 Announces PAPZIMEOS as New Standard of Care for RRP Treatment
- Standard of Care Shift: Precigen's consensus paper recommends PAPZIMEOS as the new first-line treatment for adults with recurrent respiratory papillomatosis (RRP), marking a significant shift from repeated surgeries to HPV-targeted immunotherapy, greatly enhancing treatment options for patients.
- Clinical Experience Backing: Authored by 16 leading physicians, the paper emphasizes the safety and efficacy of PAPZIMEOS based on extensive clinical experience and literature review, providing physicians with a clear treatment algorithm aimed at reducing surgical risks for patients.
- Significant Patient Impact: With approximately 27,000 adult RRP patients in the U.S., the FDA approval of PAPZIMEOS offers the first treatment addressing the root cause of the disease, potentially improving patients' quality of life and reducing healthcare burdens significantly.
- Multidisciplinary Care Advocacy: The paper underscores the importance of shared decision-making and multidisciplinary care, promoting early therapy to avoid the risks associated with repeated surgeries, thus providing a more comprehensive management strategy for RRP patients.
See More
Precigen Receives FDA Approval for PAPZIMEOS, Surpassing 200 Patient Registrations
- Rapid Commercialization: Precigen's PAPZIMEOS, approved by the FDA in August 2025, is now being prescribed nationwide, with patient registrations doubling since November to over 200, reflecting strong market demand and enthusiastic physician engagement.
- Expanded Coverage: PAPZIMEOS is now covered by private health plans for approximately 170 million lives in the U.S., including most major insurers, and is also included under Medicare and Medicaid, significantly enhancing patient access.
- European Market Expansion: The European Medicines Agency has validated the Marketing Authorization Application for PAPZIMEOS, marking a significant step in Precigen's global expansion efforts, which is expected to create new growth opportunities for the company.
- Optimistic Financial Outlook: The company anticipates that its current capital resources will fund operations until cash flow break-even, and with the rapid rollout of PAPZIMEOS, there is substantial potential for future revenue growth, further solidifying its leadership in RRP treatment.
See More
Precigen CEO Helen Sabzevari to Present at 44th Annual J.P. Morgan Healthcare Conference
- Conference Presentation: Precigen CEO Helen Sabzevari, PhD, is scheduled to present at the 44th Annual J.P. Morgan Healthcare Conference on January 15, 2026, at 7:30 AM PT in San Francisco, showcasing the company's advancements in precision medicine to attract investor interest and enhance visibility.
- Industry Engagement: Dr. Sabzevari will also participate in a fireside chat hosted by commercialization partner Eversana on January 12, 2026, at 10:30 AM PT, discussing strategic commercialization operations and strengthening connections within the biotech industry.
- Innovative Drug Development: Precigen focuses on advancing innovative precision medicines for difficult-to-treat diseases, demonstrating its robust R&D capabilities by moving scientific breakthroughs from proof-of-concept to commercialization.
- Future Outlook: The company is actively advancing its product pipeline, particularly PAPZIMEOS™ for recurrent respiratory papillomatosis, which aims to provide new treatment options for high unmet patient needs, potentially positively impacting future revenue growth.
See More
Ultragenyx Shares Plunge 42% Following Phase 3 Study Failures for Setrusumab
- Stock Plunge: Ultragenyx Pharmaceutical's shares fell sharply by 42% to $19.84 on Monday, primarily due to the failure of its Phase 3 Orbit and Cosmic studies for setrusumab (UX143) in Osteogenesis Imperfecta, leading to a significant decline in market confidence.
- Clinical Trial Failure: The results from Mereo BioPharma and Ultragenyx indicated that setrusumab did not achieve statistical significance in reducing the annualized clinical fracture rate, which not only impacts the company's short-term financial performance but may also have long-term negative implications for its future R&D investments and market competitiveness.
- Severe Market Reaction: The disappointing trial results raised investor concerns about Ultragenyx's future prospects, resulting in a substantial decrease in its market capitalization, reflecting the high sensitivity of investors to the success or failure of clinical trials in the biopharmaceutical sector.
- Industry Impact: Ultragenyx's failure could have a ripple effect across the biopharmaceutical industry, particularly in the bone metabolism disease space, as investors may adopt a more cautious approach towards similar product developments, potentially affecting financing and R&D strategies of related companies.
See More
DigitalBridge Group Inc Acquired by SoftBank Group for Approximately $4 Billion
- Acquisition Announcement: DigitalBridge Group Inc announced its acquisition by SoftBank Group for approximately $4 billion, resulting in a 9.9% stock price increase to $15.30 on Monday, indicating strong market confidence in the deal's potential to enhance the company's capital strength and market position.
- Share Buyback Program: Eightco Holdings Inc announced a share buyback program of up to $125 million, leading to a 29.1% surge in its stock price to $2.15, reflecting the company's commitment to enhancing shareholder value and boosting market confidence.
- Analyst Rating Upgrade: Piper Sandler initiated coverage on Palisade Bio with an Overweight rating and a price target of $25, which propelled its stock price up 18.6% to $2.55, showcasing market optimism regarding the company's growth potential.
- FDA Breakthrough Therapy Designation: Praxis Precision Medicines received FDA Breakthrough Therapy Designation for ulixacaltamide, resulting in a 13% increase in its stock price to $304.00, marking a significant advancement in the company's innovative drug development and potentially laying the groundwork for future market performance.
See More
Promega Collaborates with Oxford to Accelerate Precision Medicine Research
- Technological Breakthrough: Promega's collaboration with SUNY Stony Brook and the University of Oxford utilizes NanoBRET® technology to characterize inhibitors targeting cancer cells directly in live cells, revealing the connection between drug efficacy and tumor metabolic state, thus advancing precision oncology.
- Target Discovery: The study focuses on the PRMT5 protein, identifying a key vulnerability in approximately 10-15% of cancers where MTAP gene deletion alters PRMT5's interaction, potentially offering new strategies for cancer treatment.
- Biosensor Application: The CBH-002 probe developed by Oxford can measure PRMT5 inhibitor activity in live cells, demonstrating how MTA influences drug selectivity, paving the way for highly targeted therapies for MTAP-deleted cancers.
- Collaboration Between Academia and Industry: This research underscores the value of academic-industry partnerships, combining expertise in chemical biology and assay design to drive the development of future precision medicines, which holds significant strategic implications.
See More
Precigen Announces PAPZIMEOS as New Standard of Care for RRP Treatment
- Standard of Care Shift: Precigen's consensus paper recommends PAPZIMEOS as the new first-line treatment for adults with recurrent respiratory papillomatosis (RRP), marking a significant shift from repeated surgeries to HPV-targeted immunotherapy, greatly enhancing treatment options for patients.
- Clinical Experience Backing: Authored by 16 leading physicians, the paper emphasizes the safety and efficacy of PAPZIMEOS based on extensive clinical experience and literature review, providing physicians with a clear treatment algorithm aimed at reducing surgical risks for patients.
- Significant Patient Impact: With approximately 27,000 adult RRP patients in the U.S., the FDA approval of PAPZIMEOS offers the first treatment addressing the root cause of the disease, potentially improving patients' quality of life and reducing healthcare burdens significantly.
- Multidisciplinary Care Advocacy: The paper underscores the importance of shared decision-making and multidisciplinary care, promoting early therapy to avoid the risks associated with repeated surgeries, thus providing a more comprehensive management strategy for RRP patients.
See More
Precigen Receives FDA Approval for PAPZIMEOS, Surpassing 200 Patient Registrations
- Rapid Commercialization: Precigen's PAPZIMEOS, approved by the FDA in August 2025, is now being prescribed nationwide, with patient registrations doubling since November to over 200, reflecting strong market demand and enthusiastic physician engagement.
- Expanded Coverage: PAPZIMEOS is now covered by private health plans for approximately 170 million lives in the U.S., including most major insurers, and is also included under Medicare and Medicaid, significantly enhancing patient access.
- European Market Expansion: The European Medicines Agency has validated the Marketing Authorization Application for PAPZIMEOS, marking a significant step in Precigen's global expansion efforts, which is expected to create new growth opportunities for the company.
- Optimistic Financial Outlook: The company anticipates that its current capital resources will fund operations until cash flow break-even, and with the rapid rollout of PAPZIMEOS, there is substantial potential for future revenue growth, further solidifying its leadership in RRP treatment.
See More
Precigen CEO Helen Sabzevari to Present at 44th Annual J.P. Morgan Healthcare Conference
- Conference Presentation: Precigen CEO Helen Sabzevari, PhD, is scheduled to present at the 44th Annual J.P. Morgan Healthcare Conference on January 15, 2026, at 7:30 AM PT in San Francisco, showcasing the company's advancements in precision medicine to attract investor interest and enhance visibility.
- Industry Engagement: Dr. Sabzevari will also participate in a fireside chat hosted by commercialization partner Eversana on January 12, 2026, at 10:30 AM PT, discussing strategic commercialization operations and strengthening connections within the biotech industry.
- Innovative Drug Development: Precigen focuses on advancing innovative precision medicines for difficult-to-treat diseases, demonstrating its robust R&D capabilities by moving scientific breakthroughs from proof-of-concept to commercialization.
- Future Outlook: The company is actively advancing its product pipeline, particularly PAPZIMEOS™ for recurrent respiratory papillomatosis, which aims to provide new treatment options for high unmet patient needs, potentially positively impacting future revenue growth.
See More
Ultragenyx Shares Plunge 42% Following Phase 3 Study Failures for Setrusumab
- Stock Plunge: Ultragenyx Pharmaceutical's shares fell sharply by 42% to $19.84 on Monday, primarily due to the failure of its Phase 3 Orbit and Cosmic studies for setrusumab (UX143) in Osteogenesis Imperfecta, leading to a significant decline in market confidence.
- Clinical Trial Failure: The results from Mereo BioPharma and Ultragenyx indicated that setrusumab did not achieve statistical significance in reducing the annualized clinical fracture rate, which not only impacts the company's short-term financial performance but may also have long-term negative implications for its future R&D investments and market competitiveness.
- Severe Market Reaction: The disappointing trial results raised investor concerns about Ultragenyx's future prospects, resulting in a substantial decrease in its market capitalization, reflecting the high sensitivity of investors to the success or failure of clinical trials in the biopharmaceutical sector.
- Industry Impact: Ultragenyx's failure could have a ripple effect across the biopharmaceutical industry, particularly in the bone metabolism disease space, as investors may adopt a more cautious approach towards similar product developments, potentially affecting financing and R&D strategies of related companies.
See More
DigitalBridge Group Inc Acquired by SoftBank Group for Approximately $4 Billion
- Acquisition Announcement: DigitalBridge Group Inc announced its acquisition by SoftBank Group for approximately $4 billion, resulting in a 9.9% stock price increase to $15.30 on Monday, indicating strong market confidence in the deal's potential to enhance the company's capital strength and market position.
- Share Buyback Program: Eightco Holdings Inc announced a share buyback program of up to $125 million, leading to a 29.1% surge in its stock price to $2.15, reflecting the company's commitment to enhancing shareholder value and boosting market confidence.
- Analyst Rating Upgrade: Piper Sandler initiated coverage on Palisade Bio with an Overweight rating and a price target of $25, which propelled its stock price up 18.6% to $2.55, showcasing market optimism regarding the company's growth potential.
- FDA Breakthrough Therapy Designation: Praxis Precision Medicines received FDA Breakthrough Therapy Designation for ulixacaltamide, resulting in a 13% increase in its stock price to $304.00, marking a significant advancement in the company's innovative drug development and potentially laying the groundwork for future market performance.
See More
Promega Collaborates with Oxford to Accelerate Precision Medicine Research
- Technological Breakthrough: Promega's collaboration with SUNY Stony Brook and the University of Oxford utilizes NanoBRET® technology to characterize inhibitors targeting cancer cells directly in live cells, revealing the connection between drug efficacy and tumor metabolic state, thus advancing precision oncology.
- Target Discovery: The study focuses on the PRMT5 protein, identifying a key vulnerability in approximately 10-15% of cancers where MTAP gene deletion alters PRMT5's interaction, potentially offering new strategies for cancer treatment.
- Biosensor Application: The CBH-002 probe developed by Oxford can measure PRMT5 inhibitor activity in live cells, demonstrating how MTA influences drug selectivity, paving the way for highly targeted therapies for MTAP-deleted cancers.
- Collaboration Between Academia and Industry: This research underscores the value of academic-industry partnerships, combining expertise in chemical biology and assay design to drive the development of future precision medicines, which holds significant strategic implications.
See More
