24/7 Market News Snapshot 30 December, 2024 – Precigen, Inc. Common Stock (NASDAQ:PGEN)
DENVER, Colo., 30 December, 2024 (247marketnews.com) – (NASDAQ:PGEN) are discussed in this article.
Precigen, Inc. has reported notable advancements as it leverages its innovative AdenoVerse® gene therapy platform to address recurrent respiratory papillomatosis (RRP). The company recently completed a rolling submission for a biologics license application (BLA) for PRGN-2012, which aims to be the first FDA-approved therapeutic option for adults suffering from this rare and chronic condition. Patients with RRP currently endure frequent surgical interventions, highlighting the urgent need for an effective treatment solution.
Data from a pivotal Phase 1/2 study showcases the promising efficacy of PRGN-2012, with over 50% of patients achieving a Complete Response, meaning no surgical procedures for a year post-treatment. Furthermore, more than 85% of participants saw a significant reduction in the need for surgeries following administration of the therapy. This breakthrough has attracted attention as PRGN-2012 has received both Breakthrough Therapy Designation and Orphan Drug Designation from the FDA, as well as Orphan Drug Designation from the European Commission.
The safety profile of PRGN-2012 supports its potential to transform the treatment landscape for RRP, with reported findings showing no dose-limiting toxicities or serious treatment-related adverse effects. Helen Sabzevari, PhD, President and CEO of Precigen, emphasized the significance of their BLA submission, stating that it represents a vital move towards offering an effective therapeutic option for a condition that has been largely overlooked.
In tandem with this therapeutic development, Precigen’s stock has seen substantial trading activity, with shares surging more than 27% in recent sessions. The current market dynamics reflect strong investor interest, corroborated by a trading volume exceeding 5.17 million shares. As Precigen progresses towards a potential FDA-approved therapy by the latter half of 2025, it is poised not only for growth but also for a significant impact on the lives of patients affected by this debilitating disease. The company’s financial position, with a cash runway extended into 2026, further solidifies its capacity to continue developing pioneering solutions in gene and cell therapy.
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