Latest news with #PGEN
Business Insider
3 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.
Reuters
4 days ago
- Health
- Reuters
Precigen shares jump after US FDA approves first therapy for rare respiratory disease
Aug 15 (Reuters) - Precigen's (PGEN.O), opens new tab immunotherapy for a rare respiratory disease has become the first treatment to win U.S. regulatory approval for the condition, which typically requires frequent surgeries, sending the company's shares soaring 83% on Friday. The U.S. Food and Drug Administration has approved the therapy, Papzimeos, to treat adults with recurrent respiratory papillomatosis (RRP) — a condition that causes growth of benign tumors in the respiratory tract due to human papillomavirus (HPV) infection. A distinguishing aspect of RRP is the tendency for the tumors to return even after removing them through surgical procedures. The disease can be fatal as there is no cure. The FDA 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. "Randomized trials are not always needed to approve medical products and this approval is proof of that philosophy," said Vinay Prasad, who recently returned to the FDA to oversee vaccine, gene therapy and blood product regulation. Papzimeos is designed to stimulate an immune response against cells infected with HPV types 6 and 11 — the strains that cause the disease. H.C. Wainwright analysts estimate peak sales of the drug to reach $1.1 billion in 2033. "We may finally be able to say no more surgery," said Kim McClellan, president of the Recurrent Respiratory Papillomatosis Foundation. McClellan herself was diagnosed with RRP at the age of five and has since then had more than 250 surgeries. Precigen estimates about 27,000 adult RRP patients in the U.S. It did not immediately respond to a Reuters request for comment on the treatment's pricing. Simon Best, associate professor of Otolaryngology at Johns Hopkins Hospital, said patients were eagerly awaiting a new treatment. "There's nothing more frustrating than doing a surgery and then having the patient come back six months later."
Reuters
4 days ago
- Health
- Reuters
US FDA approves Precigen's immunotherapy for rare respiratory disease
Aug 15 (Reuters) - The U.S. Food and Drug Administration has approved Precigen's (PGEN.O), opens new tab immunotherapy to treat adults with a rare respiratory disease, making it the first treatment for the condition to receive the health regulator's nod. The therapy, Papzimeos, was 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 be fatal as there is no cure and the current standard-of-care is repeated surgeries. A distinguishing aspect of this disease is the tendency for the growth to return even after removing them through surgical procedures. "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," said Simon Best, associate professor of Otolaryngology at Johns Hopkins Hospital. Precigen estimates about 27,000 adult RRP patients in the U.S. It did not immediately respond to a Reuters request for comment on the treatment's pricing. "There is so much hope in the community right now, the common theme is we may finally be able to say no more surgery," said Kim McClellan, president of the Recurrent Respiratory Papillomatosis Foundation. McClellan herself was diagnosed with RRP at the age of five and has since then had more than 250 surgeries. 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. "Randomized trials are not always needed to approve medical products and this approval is proof of that philosophy," said Vinay Prasad, who recently returned to the FDA to oversee vaccine, gene therapy and blood product regulation. Papzimeos is designed to stimulate an immune response against cells infected with HPV types 6 and 11 — the strains that cause the disease. analysts estimate peak sales for the drug in the U.S. to be about $250 million.
Yahoo
01-03-2025
- Business
- Yahoo
Why Precigen, Inc. (PGEN) is Skyrocketing So Far in 2025
We recently published an article titled . In this article, we are going to take a look at where Precigen, Inc. (NASDAQ:PGEN) stands against the other biotech stocks. No matter the market environment, you'll always find entertainment in the biotech space. There will always be biotech stocks making huge swings in both directions and these stocks can make or break your portfolio in a very small amount of time due to the nature of how important clinical trial results are for these companies. The United Nations forecasts that the over-65 age group will grow by 150% from 800 million in 2024 to 2 billion by 2067. This "older, richer & sicker" population is expected to push global healthcare spending on medicines up 12% to $2.3 trillion by 2028. If you combine that with AI making breakthroughs in healthcare more frequent, you'll see many more biotech stocks starting to pop to the upside over the coming years. For this article, I screened the top-performing biotech stocks year-to-date. I will also mention the number of hedge fund investors in these stocks. Why are we interested in the stocks that hedge funds pile into? The reason is simple: our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds. Our quarterly newsletter's strategy selects 14 small-cap and large-cap stocks every quarter and has returned 373.4% since May 2014, beating its benchmark by 218 percentage points (). A technician holding a petri dish containing a DNA construction technology. Number of Hedge Fund Holders In Q4 2024: 10 Precigen, Inc. (NASDAQ:PGEN) is a company that makes gene and cell therapies with precision technology. It targets diseases in therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. The stock is up significantly so far in 2025 as the FDA granted Priority Review to the company's Biologics License Application (BLA) for PRGN-2012. This is an investigational AdenoVerse gene therapy that could treat adults with recurrent respiratory papillomatosis (RRP). This announcement came on February 25, 2025, with the FDA setting a Prescription Drug User Fee Act (PDUFA) target action date of August 27, 2025. The consensus price target of $7 implies 300% upside. Precigen, Inc. (NASDAQ:PGEN) is up 55.36% year-to-date. Overall PGEN ranks 9th on our list of the biotech stocks that are skyrocketing so far in 2025. While we acknowledge the potential of PGEN as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. If you are looking for an AI stock that is more promising than PGEN but that trades at less than 5 times its earnings, check out our report about the . READ NEXT: Why These 15 E-Commerce Stocks Are Skyrocketing So Far In 2025 and Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
