QURE Stock Edges Up After Hours As Analyst Flags Reduced Regulatory Uncertainty Following Prasad’s FDA Exit

Mizuho said that Dr. Vinay Prasad’s exit just days after a highly public dispute with uniQure appeared to signal an administration-level desire to restore greater regulatory flexibility in rare disease development.

• Mizuho believes this leadership change is "constructive for uniQure."
• H.C. Wainwright also opined earlier on Tuesday that the departure of Prasad at the end of April "reshapes the regulatory calculus" for uniQure's AMT-130.
• FDA commissioner Marty Makary confirmed on Friday that Center for Biologics Evaluation and Research chief Prasad would leave in April.

Mizuho on Tuesday upgraded uniQure (QURE) to ‘Outperform’ from ‘Neutral’, in light of Friday's "unexpected" announcement that Dr. Vinay Prasad will depart the U.S. Food and Drug Administration (FDA).

Prasad’s exit just days after a highly public dispute with uniQure, "appears to signal an administration-level desire to restore greater regulatory flexibility in rare disease development," Mizuho said.

The firm believes this leadership change is "constructive for uniQure," potentially reopening a path to an application based on the existing data or a late-stage trial leveraging natural history controls, the analyst told investors.

H.C. Wainwright also opined earlier on Tuesday that the departure of Prasad at the end of April "reshapes the regulatory calculus" for uniQure's AMT-130. H.C. Wainwright has "continued conviction" in AMT-130's existing dataset and uniQure's broader pipeline, it said, while adding that QURE shares are "poised for a value inflection."

Prasad’s Exit

FDA commissioner Marty Makary confirmed on Friday that Center for Biologics Evaluation and Research chief Prasad would leave in April. Prasad had sparred with uniQure recently, going up against the company’s gene therapy AMT-130 for ⁠Huntington's disease.

The agency has recommended that the company conduct a new controversial study, including a controversial sham surgery control group, for approval of the therapy after disagreeing with other study data submitted.

uniQure raised ethical concerns about such a trial design, arguing that it could expose patients to surgical risks without therapeutic benefit.

How Did Stocktwits Users React?

QURE stock closed 1.5% higher on Tuesday and edged up 1% after hours.

On Stocktwits, retail sentiment around QURE stock stayed within ‘bullish’ territory over the past 24 hours, while message volume stayed at ‘extremely high’ levels.

QURE stock is up 56% over the past 12 months.

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