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uniQure: Regulatory Setback on AMT-130 Seen as Surmountable, Supporting Buy Rating on Undervalued Long-Term Pipeline Upside

uniQure: Regulatory Setback on AMT-130 Seen as Surmountable, Supporting Buy Rating on Undervalued Long-Term Pipeline Upside

TD Cowen analyst Joseph Thome has maintained their bullish stance on QURE stock, giving a Buy rating yesterday.

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Joseph Thome has given his Buy rating due to a combination of factors tied to both the setback and the long‑term opportunity around AMT‑130. While the FDA’s insistence on a sham‑controlled Phase III trial delays a potential BLA, he views this as a surmountable regulatory hurdle rather than a rejection of the program’s overall promise. He notes that management had already anticipated a confirmatory trial and remains firmly committed to AMT‑130, supported by external Huntington’s disease experts who see potential for meaningful disease‑slowing benefit.

Thome also highlights the ongoing value creation from continued data generation and regulatory engagement. The company plans to refine its statistical analysis plan, deliver four‑year Phase I/II results that management believes will show durable clinical impact, and pursue parallel discussions with ex‑U.S. regulators such as the EMA and MHRA to map out additional approval pathways. Combined with progress in the broader pipeline, including upcoming AMT‑260 data, these elements underpin his view that the current valuation does not fully reflect uniQure’s medium‑ to long‑term upside potential.

In another report released yesterday, Stifel Nicolaus also maintained a Buy rating on the stock with a $14.00 price target.

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