Leerink Partners analyst Joseph Schwartz has maintained their bullish stance on RARE stock, giving a Buy rating yesterday.
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Joseph Schwartz’s rating is based on the belief that the recent Complete Response Letter (CRL) from the FDA regarding Ultragenyx’s UX111 program is not a major setback for the company’s overall investment thesis. Although the CRL requires Ultragenyx to address specific chemistry, manufacturing, and controls (CMC) issues, these are considered resolvable and not related to the product’s quality. The FDA has acknowledged the robustness of the neurodevelopmental outcome data and supportive biomarker data, indicating that the clinical data package is solid.
Schwartz emphasizes that the UX111 program is not central to Ultragenyx’s core strategy, with expected peak sales of approximately $150 million and a high probability of success. The focus remains on other promising programs like setrusumab and ORBIT, with data anticipated by the end of 2025 or early 2026. Despite recent challenges, Schwartz maintains an Outperform rating, suggesting confidence in the company’s long-term potential.
In another report released yesterday, Bank of America Securities also reiterated a Buy rating on the stock with a $79.00 price target.