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Ultragenyx Pharmaceutical: Buy Rating Affirmed Amid Manageable FDA Setbacks and Promising Clinical Data

Ultragenyx Pharmaceutical: Buy Rating Affirmed Amid Manageable FDA Setbacks and Promising Clinical Data

William Blair analyst Sami Corwin has maintained their bullish stance on RARE stock, giving a Buy rating today.

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Sami Corwin’s rating is based on several factors that highlight the potential of Ultragenyx Pharmaceutical despite recent setbacks. The company received a complete response letter from the FDA regarding UX111 for treating Sanfilippo syndrome type A, which cited concerns related to chemistry, manufacturing, and controls (CMC). However, Ultragenyx believes these issues are manageable and not directly related to the product’s quality.
Furthermore, the FDA acknowledged the supportive nature of the clinical data for UX111, including robust neurodevelopmental outcomes and biomarker evidence. Although the FDA requested updated clinical data, the absence of issues with the existing data package is a positive sign. Ultragenyx plans to address the FDA’s concerns promptly, aiming for a resubmission and potential approval in 2026, which underpins the Buy rating given by Sami Corwin.

According to TipRanks, Corwin is a 3-star analyst with an average return of 3.2% and a 40.40% success rate. Corwin covers the Healthcare sector, focusing on stocks such as Sarepta Therapeutics, PTC Therapeutics, and Ultragenyx Pharmaceutical.

In another report released today, TD Cowen also maintained a Buy rating on the stock with a $86.00 price target.

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