Precigen Soars: Biologics License Application Submission For PRGN-2012 Targets First FDA-Approved Recurrent Respiratory Papillomatosis Treatment
Precigen Soars: Biologics License Application Submission For PRGN-2012 Targets First FDA-Approved Recurrent Respiratory Papillomatosis Treatment
Current treatment involves repeated surgeries, which don't address the root cause and lead to recurring disease.Precigen, Inc. (NASDAQ:PGEN) shares are trading higher on Monday after the company completed the rolling submission for a biologics license application to the FDA for PRGN-2012 (zopapogene imadenovec) to treat adult patients with recurrent respiratory papillomatosis.
Precigen公司（納斯達克:PGEN）的股價在週一上漲，因爲該公司已完成了向FDA提交PRGN-2012（zopapogene imadenovec）生物製品許可證申請的滾動提交，以治療複發性呼吸道乳頭狀瘤患者。
PRGN-2012 is an investigational AdenoVerse gene therapy targeting HPV 6 and HPV 11 infections. It has received Breakthrough Therapy and Orphan Drug Designations from the FDA, and Orphan Drug Designation from the European Commission.
PRGN-2012是一種針對HPV 6和HPV 11感染的研究性AdenoVerse基因療法。它已獲得FDA的突破性療法和孤兒藥資格認定，以及歐洲委員會的孤兒藥資格認定。
PRGN-2012 could become the first FDA-approved treatment for recurrent respiratory papillomatosis, a rare, life-threatening condition with no cure.
PRGN-2012可能成爲第一個獲得FDA批准的複發性呼吸道乳頭狀瘤治療藥物，這是一種罕見的、危及生命的控制項，目前沒有治癒的方法。
Current treatment involves repeated surgeries, which don't address the root cause and lead to recurring disease.
當前的治療方法涉及重複手術，但並未解決根本原因，導致疾病反覆發作。
The submission is now under the FDA's initial 60-day review period, during which the agency will determine whether to accept the application for further review and establish the Prescription Drug User Fee Act action date.
該申請目前正處於FDA的初步60天審查期，期間該機構將判斷是否接受申請進行進一步審查，並確定處方藥用戶收費法案的行動日期。
The biologics license application includes a request for priority review, which, if granted, would shorten the review timeline from 10 months to 6 months.
生物製品許可證申請包括優先審查的請求，如果獲得批准，將把審查時間從10個月縮短到6個月。
The BLA for PRGN-2012 is backed by a Phase 1/2 study (NCT04724980) in 38 RRP patients. The primary safety and efficacy endpoints were met, as reported in the results from the pivotal study presented at the 2024 ASCO annual meeting.
PRGN-2012的生物製品許可證申請得到了對38名RRP患者進行的1/2期研究（NCT04724980）的支持。根據在2024年ASCO年會上公佈的關鍵研究結果，主要安全性和有效性終點均已滿足。
Helen Sabzevari, PhD, President and CEO of Precigen, said, "There is currently no approved therapy for RRP patients and the submission of our BLA is an extremely important step in bringing the first therapy to fight this devastating disease."
Precigen的總裁兼首席執行官Helen Sabzevari博士表示：「目前尚無針對RRP患者的批准療法，而我們提交生物製品許可證申請是爲這一毀滅性疾病帶來首個治療方案的重要一步。」
"We look forward to working closely with the FDA on next steps now that we have completed the BLA submission and we are excited by the potential to bring PRGN-2012 to RRP patients as quickly as possible."
「我們期待與FDA緊密合作，進行下一步工作，現在我們已完成BLA提交，我們對將PRGN-2012快速帶給RRP患者的潛力感到興奮。」
"With our most recent financial transactions announced last week to enhance our balance sheet, we have extended our cash runway into 2026, well beyond potential commercial launch in the second half of 2025."
「通過上週宣佈的最新財務交易來增強我們的資產負債表，我們已經將現金使用期限延長到2026年，遠遠超過2025年下半年潛在的商業發佈。」
Price Action: PGEN shares are up 23.9% at $0.9000 at the last check Monday.
價格動態：PGEN股票在週一最後檢查時上漲了23.9%，價格爲0.9000美元。
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譯文內容由第三人軟體翻譯。
