On Thursday, H.C. Wainwright adjusted its price target for shares of Precigen Inc. (NASDAQ:PGEN), reducing it to $4.00 from the previous $6.00, while continuing to endorse the stock with a Buy rating. This revision follows the company's announcement in June regarding its pivotal Phase 1/2 study of PRGN-2012, a treatment for recurrent respiratory papillomatosis (RRP).
The study achieved its primary and secondary endpoints, demonstrating the drug's sustained effectiveness in preventing surgical interventions in RRP patients over a 12-month period.
Precigen is reportedly on schedule to submit a rolling Biologics License Application (BLA) for accelerated approval in the second half of 2024. The firm has also begun enrolling patients for the confirmatory Phase 3 study. The analyst anticipates a swift enrollment process due to the compelling data from the pivotal study and the considerable need for treatment in this rare disease area.
The analyst's projections include the expectation that PRGN-2012 will begin generating risk-adjusted revenue in 2026, estimated at $106 million, and anticipates growth to $521 million by 2030. Despite the lowered price target, the firm's outlook on Precigen remains positive, with the expectation that the company's drug development will meet significant milestones in the coming years.
In other recent news, Precigen, Inc. has been making significant strides in its gene therapy program, PRGN-2012, for the treatment of recurrent respiratory papillomatosis (RRP). The therapy has demonstrated promising clinical trial results, with over half of the patients showing a complete response and a significant reduction in surgeries.
The FDA has granted breakthrough designation to PRGN-2012, and Precigen has plans to submit a Biologics License Application (BLA) by the end of 2024.
In preparation for potential commercialization in 2025, Precigen has appointed Phil Tennant as Chief Commercial Officer and initiated a confirmatory trial. The company has also taken strategic steps such as workforce reduction and cost-saving measures to prioritize PRGN-2012. Additionally, Precigen has paused some clinical trials and is seeking partnerships for its UltraCAR-T platform.
These recent developments are part of Precigen's strategic focus on PRGN-2012, and the company has raised $31.4 million through an equity issuance to extend its cash runway into early 2025.
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