PGEN Stock Surges More Than 40% in a Week: What's Driving the Rally?

Zacks01-03

Shares of Precigen PGEN have soared nearly 43% in the past week after the company provided an encouraging regulatory update for its lead pipeline program. Last week, Precigen announced that it has ...

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It is caused by two types of human papilloma virus  – HPV 6 and HPV 11.The BLA is supported by data from a pivotal phase I/II study that evaluated PRGN-2012 for the treatment of adult patients with RRP. Data from the study showed that more than 50% of patients achieved a complete response . Also, more than 85% of patients experienced a reduction in surgical interventions in the year after receiving PRGN-2012 compared to the year before receiving the therapy.Precigen currently carries ","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{},"translate_title":"PGEN股价一周内飙升超过40%：是什么推动了上涨？","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CSTL":1,"INO":1,"PGEN":1,"CTMX":0.9},"content_text":"Shares of Precigen PGEN have soared nearly 43% in the past week after the company provided an encouraging regulatory update for its lead pipeline program.\nLast week, Precigen announced that it has completed a rolling submission for a biologic license application (BLA) seeking the FDA’s accelerated approval for PRGN-2012, an experimental gene therapy to treat adults with recurrent respiratory papillomatosis (RRP).\nA rare disease, RRP causes benign tumors (called papillomas) to grow in the respiratory tract, most commonly in the larynx (voice box). It is caused by two types of human papilloma virus (HPV) – HPV 6 and HPV 11.\nMore on PGEN’s BLA Filing for PRGN-2012\nThe BLA is supported by data from a pivotal phase I/II study that evaluated PRGN-2012 for the treatment of adult patients with RRP. Data from the study showed that more than 50% of patients achieved a complete response (defined as the percentage of patients who require no RRP surgeries). Also, more than 85% of patients experienced a reduction in surgical interventions in the year after receiving PRGN-2012 compared to the year before receiving the therapy.\nThe regulatory filing is currently in the initial 60-day review period and the FDA will decide whether to accept the application for further review and set the target action by this period. Management has requested a priority review for this filing, which, if granted, will reduce the agency’s review period by four months.\nIf the FDA approves this filing, PRGN-2012 will be the first FDA-approved therapeutic for adults with RRP. The disease currently has no cure, and the standard treatment involves repeated surgeries. However, these procedures only manage symptoms and do not address the root cause of the disease, often leading to a cycle of recurrences. It has been observed that patients with RRP frequently require surgeries over their lifetime.\nManagement expects a potential approval for PRGN-2012 before this year’s end. The gene therapy has already received breakthrough therapy and orphan drug designation from the FDA in RRP indication.\nPGEN Stock Performance\nIn the past year, Precigen’s shares have lost 13.9% compared with the industry’s 13.6% fall.\nImage Source: Zacks Investment Research\nOther Players in the RRP Space\nAnother company developing its own RRP medication is Inovio INO, which is evaluating INO-3107 in a pivotal phase I/II study. However, the Inovio drug is an investigational DNA medicine designed to generate an antigen-specific T-cell response against both HPV-6 and HPV-11 proteins.\nManagement plans to submit a regulatory filing with the FDA in mid-2025 seeking accelerated approval for the drug in the RRP indication.\nLike PRGN-2012, the FDA has also granted breakthrough therapy and orphan drug designations to INO-3107 in RRP indication.\nPGEN’s Zacks Rank\nPrecigen currently carries a Zacks Rank #3 (Hold).\n\nPrecigen, Inc. Price\n\nPrecigen, Inc. price | Precigen, Inc. Quote\n\nKey Picks Among Biotech Stocks\nSome better-ranked stocks from the sector are Castle Biosciences CSTL and CytomX Therapeutics CTMX, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.\nBottom-line estimates for Castle Biosciences have improved from a loss of 59 cents per share to earnings of 34 cents for 2024 in the past 60 days. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.15 to $1.84. In the past year, shares of Castle Biosciences have surged 28.2%.\nCSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.\nIn the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 29 cents to 5 cents. Estimates for 2025 loss per share have narrowed from 56 cents to 35 cents during the same timeframe. CTMX’s shares have lost 36.8% in the past year.\nCytomX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 115.70%.\nWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report\nInovio Pharmaceuticals, Inc. (INO) : Free Stock Analysis Report\nCytomX Therapeutics, Inc. (CTMX) : Free Stock Analysis Report\nCastle Biosciences, Inc. (CSTL) : Free Stock Analysis Report\nPrecigen, Inc. (PGEN) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.30.0","shortVersion":"4.30.0","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2500902522"}