Regenxbio Inc. (RGNX) PT Raised to $18 at Leerink

Leerink analyst Mani Foroohar raised the price target on Regenxbio Inc. (NASDAQ: RGNX) to $18.00 (from $17.00) while maintaining a Outperform rating.

The analyst commented, "This morning, RGNX announced FDA alignment on a BLA resubmission via accelerated approval (AA) pathway Navsunli (RGX-121) in Mucopolysaccharidosis II (MPS II). Earlier this year RGNX received a CRL due to uncertainty around study eligibility criteria (neuronopathic vs. attenuated disease), comparability of natural history controls, and CSF HS D2S6 as a surrogate endpoint (note here). Following further engagement, FDA indicated existing data are sufficient for AA consideration, with no additional patients or studies required. RGNX will now request a Type A meeting to review the data (expected in July), and resubmit the BLA after that meeting (expected 3Q26). Labeling discussions are expected to begin shortly after resubmission. We update our Navsunli PoS in MPS II to 50%, which increases our PT to $18 and reiterate OP."

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