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On Tuesday, Stifel analysts reiterated a Buy rating on Precigen Inc. (NASDAQ:PGEN) with a maintained price target of $7.00. The stock, which has surged over 56% year-to-date according to InvestingPro data, currently trades at $1.78, suggesting significant upside potential to analyst targets ranging from $5.00 to $7.00. This endorsement follows the announcement that Precigen’s Biologics License Application (BLA) for PRGN-2012, aimed at treating Recurrent Respiratory Papillomatosis (RRP), has been accepted by the FDA for priority review. The Prescription Drug User Fee Act (PDUFA) date is set for August 27, 2025, and currently, no advisory committee meeting is anticipated. With a market capitalization of $524 million and an overall Financial Health score of "Fair" from InvestingPro, the company’s development progress is crucial for its future prospects.
The analysts expressed a strong belief in the potential approval of the drug, highlighting the significant efficacy observed, with approximately a 50% complete response rate, its relatively benign safety profile, and the pressing unmet medical need in RRP treatment. The FDA’s decision to forgo an advisory committee suggests a smooth path towards accelerated approval, particularly given the durable nature of most complete responses (CRs).
Stifel’s analysis also pointed out that while there are clinical questions regarding the possibility of re-dosing, the FDA has requested that Precigen consider exploring this in a post-market study. This issue is not expected to significantly impact the review process for accelerated approval.
The firm is looking forward to an update on the confirmatory study during the upcoming earnings report, scheduled for February 26 according to InvestingPro data. The study has been enrolling participants since mid-2024, and analysts at Stifel are not concerned about its progress. They believe that even conservative estimates of the commercial opportunity for PRGN-2012, particularly among severely affected patients, suggest there could be an upside to Precigen’s stock value. Additionally, the potential to establish pricing similar to that of one-and-done rare disease treatments could further enhance the stock’s appeal. Investors seeking deeper insights can access comprehensive analysis and 14 additional ProTips through InvestingPro’s detailed Research Report on Precigen.
In other recent news, Precigen Inc. announced that the U.S. Food and Drug Administration (FDA) has granted priority review for its biologics license application (BLA) for PRGN-2012, a gene therapy for recurrent respiratory papillomatosis (RRP). The FDA’s priority review status highlights the urgent need for a treatment for this rare disease, with a target action date set for August 27, 2025. Clinical trials showed promising results, with over 50% of patients achieving a complete response and a significant reduction in surgical interventions. In a separate development, Precigen has secured $79 million through a private placement of its Series A Convertible Perpetual Preferred Stock, intended to extend the company’s cash runway into 2026. This extension anticipates the potential commercial launch of PRGN-2012 in the second half of 2025, pending approval. Additionally, Precigen completed the sale of certain assets, including intellectual property related to FCX-007, to Innovator 21 for $8.5 million. The proceeds from this sale will be directed towards working capital and general corporate purposes. Furthermore, Precigen regained compliance with Nasdaq’s minimum bid price requirement, maintaining a closing price above $1.00 per share for ten consecutive business days.
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