Precigen Inc Stock News

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PAPZIMEOS's full FDA approval for RRP is a decisive, de-risking event and validates Precigen's immunotherapy platform. PAPZIMEOS targets a significant unmet need, with potential for $1B+ peak sales, though logistical hurdles and launch friction exist. Precigen faces imminent financing needs due to limited cash runway and increased burn from its first commercial launch.

The U.S. Food and Drug Administration has approved Precigen's immunotherapy to treat adults with a rare respiratory disease, making it the first treatment for the condition to receive the health regulator's nod.

PAPZIMEOS approval marks a historic milestone for the RRP patient community as the first and only FDA-approved therapy for the treatment of adults with RRP PAPZIMEOS received full approval from the FDA for the treatment of adults with RRP; a confirmatory clinical trial is no longer required  RRP is a rare, debilitating, and potentially life-threatening disease caused by chronic HPV 6 or HPV 11 ...

Precigen's future hinges on the FDA's approval of PRGN-2012, with a pivotal decision expected August 27, 2025. PRGN-2012 shows strong efficacy and safety, potentially transforming the treatment of Recurrent Respiratory Papillomatosis and opening up a $2 billion global market opportunity. Despite promising science, Precigen has long-faced severe financial challenges and a very short cash runway ...

PRGN-2012 has the potential to be the first- and best-in-class treatment for RRP Company's BLA for PRGN-2012 for the treatment of adults with RRP is under priority review by the FDA with a PDUFA target action date set for August 27, 2025 RRP is a rare, debilitating chronic disease with approximately 27,000 adult patients in the US and more than 125,000 patients outside of the US Company continu...

– International event will raise awareness and bring together RRP patients , caregivers, and the healthcare community supporting them – – Recurrent respiratory papillomatosis is a rare, debilitating, chronic disease that impacts both children and adults and is mainly driven by HPV 6/11 infection – – There is no FDA-approved therapeutic for the treatment of RRP, and the current standard-of-care ...

Precigen, Inc. (NASDAQ:PGEN ) Q4 2024 Earnings Conference Call March 19, 2025 4:30 PM ET Company Participants Steven Harasym - IR Helen Sabzevari - President and CEO Rutul Shah - COO Phil Tennant - CCO Harry Thomasian - CFO Conference Call Participants Jason Butler - Citizens Carolina Ibanez Ventoso - Stifel Swayampakula Ramakanth - H.C. Wainwright Jennifer Kim - Cantor Brian Cheng - JPMorgan O...