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Investing.com - H.C. Wainwright has reiterated its Buy rating and $8.50 price target on Precigen Inc. (NASDAQ:PGEN) following the FDA’s full approval of Papzimeos for treating adults with recurrent respiratory papillomatosis (RRP). The stock, currently trading at $2.95, has shown remarkable momentum with a 163% return year-to-date. According to InvestingPro data, the company has demonstrated significant price strength across multiple timeframes.
The FDA decision came two weeks earlier than the expected PDUFA action date, with Precigen announcing the approval during a conference call on Monday. The company has set the wholesale acquisition cost (WAC) for a full treatment cycle at $460,000, which includes four single-use vials at $115,000 each for the 12-week treatment course. With a current market capitalization of $870 million and a favorable current ratio of 2.71, InvestingPro analysis indicates the company maintains solid liquidity to support its commercialization efforts.
Precigen plans to launch Papzimeos in the fourth quarter of 2025, with management indicating they expect to use a miscellaneous J-Code for reimbursement rather than waiting for the typical 6-9 month J-Code approval process. The company believes it will have sufficient drug supply to meet initial demand at launch.
The commercial strategy will target 93 Integrated Delivery Networks and community hospitals, which Precigen estimates will reach approximately 80% of the prescribing physician base. For markets outside the United States, the company intends to identify a commercial partner in the near future.
H.C. Wainwright projects Papzimeos sales of $15 million in the fourth quarter of 2025 and $138 million in 2026, with the analyst noting that Precigen is one of the firm’s top picks for the second half of 2025. The consensus among analysts remains bullish, with price targets ranging from $8.00 to $8.50, suggesting significant upside potential. Discover more detailed analysis and 14 additional key insights about Precigen through InvestingPro’s comprehensive research reports.
In other recent news, Precigen Inc. has achieved a significant milestone with the U.S. Food and Drug Administration granting full approval to PAPZIMEOS for the treatment of recurrent respiratory papillomatosis (RRP) in adults. This marks the first and only FDA-approved therapy specifically targeting this rare condition. Following this approval, Citizens JMP raised its price target for Precigen to $8.00, citing the treatment’s pricing and launch plans as key factors. Meanwhile, JMP Securities maintained its price target at $6.00, reaffirming a Market Outperform rating and highlighting the potential of Precigen’s PRGN-2012 therapy for RRP.
Additionally, Precigen has entered into a commercial supply agreement with Catalent (NYSE:CTLT) Maryland, Inc. for the manufacturing of PAPZIMEOS. This agreement outlines that Catalent will handle various services such as development, processing, and product maintenance. Under the terms, Precigen is committed to using Catalent exclusively for commercial manufacturing in the specified territory. These developments reflect Precigen’s strategic moves to advance its position in the biopharmaceutical sector.
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