uniQure (QURE) Valuation Update After FDA Feedback Clouds AMT-130’s Current Path to a Biologics Filing

uniQure (NasdaqGS:QURE) just received final meeting minutes from the FDA on its AMT-130 gene therapy for Huntington's disease, and regulators signaled that current Phase I/II data likely will not anchor a Biologics License Application.

See our latest analysis for uniQure.

The cautious FDA feedback lands after a volatile stretch, with uniQure’s share price at $20.43, a 30 day share price return of negative 31.63 percent, a 90 day share price return of 44.28 percent, and a 1 year total shareholder return of 24.12 percent. This suggests sentiment has improved recently, even as longer term total shareholder returns over three and five years remain negative.

If you are weighing how this regulatory twist fits into the broader biotech landscape, it can help to compare uniQure with other specialised healthcare names using healthcare stocks.

With AMT-130’s regulatory path now clouded and shares still trading at a steep discount to analyst targets, is uniQure an overlooked value in high risk gene therapy, or is the market correctly discounting its future growth?

Most Popular Narrative Narrative: 64.9% Undervalued

With uniQure last closing at $20.43 against a narrative fair value of $58.21, the valuation gap rests on aggressive long term growth and margin shifts.

The analysts have a consensus price target of $35.514 for uniQure based on their expectations of its future earnings growth, profit margins and other risk factors. However, there is a degree of disagreement amongst analysts, with the most bullish reporting a price target of $69.56, and the most bearish reporting a price target of just $13.41.

Read the complete narrative.

Curious how a loss making biotech earns such a rich future earnings multiple and rapid revenue ramp in this narrative? The underlying profitability pivot and share count assumptions may surprise you.

Result: Fair Value of $58.21 (UNDERVALUED)

Have a read of the narrative in full and understand what's behind the forecasts.

However, persistent FDA uncertainty around AMT-130 and continued revenue volatility could quickly challenge assumptions underpinning today’s undervalued narrative.

Find out about the key risks to this uniQure narrative.

Build Your Own uniQure Narrative

If this view does not quite fit your own, explore the data directly and develop your own perspective in minutes, starting with Do it your way.

A great starting point for your uniQure research is our analysis highlighting 2 key rewards and 3 important warning signs that could impact your investment decision.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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