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On Thursday, H.C. Wainwright reaffirmed its confidence in Precigen Inc. (NASDAQ:PGEN) by maintaining a Buy rating and a price target of $6.00. According to InvestingPro data, the stock has shown strong momentum with an 80% price return over the past six months, though currently trades above its Fair Value. The positive outlook follows the recent acceptance by the FDA of the Biologics License Application (BLA) for PRGN-2012, a potential treatment for recurrent respiratory papillomatosis (RRP).
The FDA has set a Prescription Drug User Fee Act (PDUFA) date for August 27, 2025, for the review of PRGN-2012. While InvestingPro analysis indicates the company is quickly burning through cash with negative EBITDA of $89.5 million, analysts at H.C. Wainwright believe the approval process will be straightforward, noting that the FDA does not plan to convene an advisory committee meeting and that the Phase 3 study enrollment is progressing smoothly.
PRGN-2012 stands to be the first FDA-approved therapy for RRP, with advantages such as strong and lasting efficacy, ease of subcutaneous administration, favorable safety profile, and redosing options. The sustained surgery-free status of patients who achieved a complete response in the Phase 1 study, nearly three years post-treatment, underscores the drug’s long-term potential.
To prepare for a successful commercial launch, Precigen has expanded its manufacturing capacity and partnered with Eversana, a company specializing in the commercialization of rare disease therapies. The company’s strategy includes targeting an initial group of 500 prescribers who manage the majority of the 27,000 U.S. patients diagnosed with RRP.
H.C. Wainwright projects that PRGN-2012 could generate risk-adjusted revenues of $93 million in 2026, with the potential to increase to $969 million by 2033. The firm’s sustained Buy rating and 12-month price target of $6.00 per diluted share reflect their optimistic view of Precigen’s market potential and strategic preparations for the drug’s anticipated approval and launch. InvestingPro data reveals analyst consensus remains bullish, with targets ranging from $6.00 to $7.00, suggesting significant upside potential. Subscribers can access 10+ additional ProTips and comprehensive financial metrics in the Pro Research Report.
In other recent news, Precigen Inc. announced a net loss of $126.2 million for the fiscal year 2024, an increase from the $95.9 million loss reported in 2023. Despite these results, the company is optimistic about future revenue streams, particularly with the FDA’s acceptance of their Biologics License Application (BLA) for PRGN-2012 under a priority review. This development could potentially lead to a significant market entry, as there are currently no approved therapies for the targeted condition, Recurrent Respiratory Papillomatosis (RRP). Precigen also ended 2024 with a cash position of $97.9 million, which they believe will support operations well into 2026, aided by a $79 million preferred stock issuance. Analysts have shown interest in the company’s strategic advancements, and Precigen expects commercial revenues to begin in the second half of 2025. The company is preparing for the potential launch of PRGN-2012, which targets approximately 27,000 adult RRP patients in the U.S. Meanwhile, Precigen’s focus on innovative therapies and strategic positioning has been noted as key drivers of investor optimism, despite the ongoing financial losses.
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