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On Friday, JMP Securities analyst Jonathan Wolleben maintained a Market Outperform rating and a $19.00 price target for Aura Biosciences , traded on (NASDAQ:AURA). This target represents significant upside potential, though InvestingPro analysis suggests the stock is currently trading above its Fair Value. Wolleben’s stance comes after carefully reviewing the outcomes of a recent FDA advisory committee meeting for a competing drug, UGN-102, developed by UroGen Pharma for the treatment of non-muscle invasive bladder cancer (NMIBC).
The advisory committee was divided on the benefit/risk assessment of UGN-102 for low-grade, intermediate-risk NMIBC, with a narrow vote of 5-4 suggesting that the benefits may not outweigh the risks. A key issue identified was the lack of a randomized pivotal trial, which the FDA had recommended. This resulted in challenges interpreting the trial data, particularly concerning the durability of the response and the risk of recurrence.
Despite these challenges, the FDA did recognize an unmet medical need in this area, which is seen as a positive for Aura Biosciences. The company, which maintains a strong financial position with more cash than debt and a healthy current ratio of 11.06, is currently conducting a Phase 1b/2 trial for its own drug, bel-sar, in both intermediate and high-risk NMIBC. InvestingPro data reveals the company’s overall financial health score is FAIR, though it’s currently burning through cash rapidly. Wolleben highlighted the importance of Aura demonstrating a convincing efficacy signal in the ongoing trial, with results expected around the end of 2025.
The trial will continue to monitor patients for 12 months, providing sufficient data to assess the potential for advancing the treatment. Bel-sar is also being evaluated as a frontline treatment, with a mechanism that combines direct cytotoxicity with immune-mediated effects, potentially addressing the FDA’s concerns about durability and recurrence.
Wolleben views the bladder cancer treatment opportunity as an additional value to Aura’s current market capitalization of $368.31 million, with an estimated U.S. incidence of approximately 83,000 cases. With a relatively low beta of 0.43, the stock shows lower volatility compared to the broader market. He considers bel-sar a potentially differentiated, targeted treatment option that could eventually replace transurethral resection of bladder tumors (TURBT) for patients with both primary and recurrent low-grade NMIBC. Discover more key financial metrics and insights with InvestingPro, including additional ProTips and detailed financial analysis.
In other recent news, Aura Biosciences reported a net loss of $29 million for the first quarter, which was higher than anticipated, alongside operating expenses that exceeded consensus estimates by $5 million. The company maintains a robust cash reserve of $199 million, expected to last into the second half of 2026, with recent financing potentially extending this runway by an additional 6 to 9 months. Aura Biosciences also announced a $75 million public offering, pricing over 11.7 million shares of common stock and warrants, with proceeds aimed at advancing clinical programs for various cancers. Citizens JMP reiterated a Market Outperform rating with a $19 price target, highlighting the company’s progress in its Phase 3 CoMpass trial for bel-sar, a treatment for primary uveal melanoma. Analyst Jonathan Wolleben expressed optimism about bel-sar’s potential market opportunity in uveal melanoma, projecting it as a treatment with over a $1 billion opportunity. Aura Biosciences has also initiated a Phase 1b/2 trial of bel-sar for non-muscle invasive bladder cancer, with initial data expected later this year. Additionally, the company expanded its Board of Directors with the appointment of Teresa Bitetti, bringing significant experience from her leadership role in Takeda’s Global Oncology Business Unit. Meanwhile, JMP Securities adjusted Aura’s stock target to $19 from $21, maintaining a Market Outperform rating, noting positive feedback from Key Opinion Leaders on bel-sar’s early trial results.
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