Latest news with #HelenSabzevari
Business Insider
2 days ago
- Health
- Business Insider
Precigen Stock (PGEN) Roars Over 60% Higher on FDA Green Light for Papzimeos Therapy
Shares in biopharmaceutical company Precigen (PGEN) rocketed higher today after the U.S. Food and Drug Administration gave the green light to a therapy to treat a rare respiratory disease. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. The approval of the therapy, called Papzimeos, is the first treatment for the condition to receive the health regulator's nod. Fatal Tumors Papzimeos has been approved to treat recurrent respiratory papillomatosis (RRP) — a condition that causes growth of wart-like tumors in the respiratory tract due to human papillomavirus (HPV) infection. RRP can lead to severe voice disturbance, a compromised airway, and recurrent post-obstructive pneumonias. Precigen estimates that there are about 27,000 adult RRP patients in the U.S. RRP can be fatal as there is no cure and the current standard-of-care is repeated surgeries. However, despite being removed in these surgeries, the growth has a tendency to return. 'For more than a century, since RRP was first recognized as a distinct disease, patients have had to rely on repeated surgeries to manage this relentless condition. Today marks a historic turning point. With the landmark FDA approval all adult RRP patients are now eligible for access to the first and only approved therapy that targets the root cause of the disease,' said Helen Sabzevari, PhD, President and CEO of Precigen. Analyst Upgrade Simon Best, associate professor of Otolaryngology at Johns Hopkins Hospital, added: 'Everybody is anxiously awaiting a new treatment for this disease. The patients are and the surgeons are. There's nothing more frustrating than doing a surgery and then having the patient come back six months later.' The approval was based on an early-to-mid-stage study data that showed 51% of patients required no surgeries in the 12 months after the treatment. upgraded Precigen to Neutral from Underweight on the news. It cited the removal of Precigen's 'major regulatory overhang' and its revenue potential for the upgrade. It estimates that peak sales for the drug in the U.S. to be about $250 million. Precigen is certainly making strides when it comes to its financials – as can be seen below. Precigen recently reported a Q2 net loss of $26.6 million, a significant improvement from the $58.8 million loss in the same period last year. Total revenues for the quarter were $856,000, up from $717,000 in the previous year, driven by increased service revenues. Is PGEN a Good Stock to Buy Now? On TipRanks, PGEN has a Hold consensus based on 2 Buy, 1 Hold and 1 Sell ratings. Its highest price target is $6. PGEN stock's consensus price target is $4.50, implying a 143.24% upside.
Yahoo
20-03-2025
- Business
- Yahoo
Precigen Inc (PGEN) Q4 2024 Earnings Call Highlights: Navigating Challenges and Seizing ...
Net Loss: $126.2 million for 2024, compared to $95.9 million in 2023. Net Loss Per Share: $0.47 per basic and diluted share for 2024, compared to $0.39 in 2023. Cash Burn: $76.8 million for 2024, including cash used in operations and capital expenditures. Cash, Cash Equivalents, and Investments: $97.9 million at the end of 2024. Preferred Stock Issuance: Raised $79 million at the end of 2024. Non-Dilutive Monetization: $8.5 million from the sale of intellectual property and royalty rights. Warning! GuruFocus has detected 7 Warning Signs with PGEN. Release Date: March 19, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Precigen Inc (NASDAQ:PGEN) is on the verge of commercializing its lead asset, PRGN-2012, with a PDUFA date set for August 27, 2025. PRGN-2012 has demonstrated a 51% complete response rate in clinical trials, with durable responses lasting up to 24 months. The company has built a dedicated GMP facility for in-house manufacturing, ensuring better control over production and costs. Precigen Inc (NASDAQ:PGEN) has established a comprehensive commercialization strategy, including a partnership with a proven leader in rare disease launches. The company has a strong financial position, with cash reserves expected to support operations well into 2026. Precigen Inc (NASDAQ:PGEN) reported a net loss of $126.2 million for 2024, an increase from the previous year's loss. The confirmatory trial for PRGN-2012 will not be completed by the PDUFA date, with results expected in 2026 or 2027. There is uncertainty regarding the FDA's pre-approval inspection timing, which is part of the regulatory process. The company faces challenges in ensuring payer access and pricing strategies for PRGN-2012, with potential utilization management by payers. Precigen Inc (NASDAQ:PGEN) has yet to publish data from its Phase I study of PRGN-3006, with no specific timeline provided for its release. Q: Can you provide an update on interactions with the FDA regarding PRGN-2012 and your commercial launch plans? A: Helen Sabzevari, CEO, stated that Precigen has maintained close interactions with the FDA, receiving priority review for their BLA submission. Phil Tennant, Chief Commercial Officer, mentioned that they plan to deploy a field force of 15 to 20 representatives targeting around 500 otolaryngologists concentrated in urban academic centers. Q: Are there any updates on FDA pre-licensing inspections and labeling discussions? A: Helen Sabzevari, CEO, noted that inspections are part of the regulatory process, especially for GMP facilities, and they remain in close alignment with the FDA as they approach the PDUFA date. Q: How do you plan to address the anticipated demand for PRGN-2012 upon approval? A: Phil Tennant, Chief Commercial Officer, expects a significant demand due to the lack of existing treatments. They plan to ensure timely access by deploying their team to reach as many patients as possible. Q: What is the status of the confirmatory trial for PRGN-2012, and when can we expect data from the PRGN-3006 Phase I study? A: Helen Sabzevari, CEO, stated that the confirmatory trial for PRGN-2012 has begun enrolling patients, with completion expected in 2026-2027. Updates on the PRGN-3006 data will be provided after discussions with the FDA. Q: Can you elaborate on your pricing strategy and payer access for PRGN-2012? A: Phil Tennant, Chief Commercial Officer, mentioned ongoing discussions with payers, aiming for a price point that reflects the drug's value. They are exploring value-based agreements but expect straightforward pricing aligned with payer expectations. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
