Regenxbio, Replimune among gainers after FDA U-turn on UniQure

 

uniQure's positive FDA gene therapy feedback sparks sector rally, lifting REGENXBIO 22%

• RGNX shares surged ~21.79% to ~$8.00-$8.50 range on June 17 with elevated volume.
• Catalyst tied to uniQure (QURE +80%+ same day) after FDA indicated 3-year Phase 1/2 AMT-130 data can support accelerated approval BLA for Huntington's gene therapy.
• Positive regulatory signal for AAV gene therapies benefits peers like REGENXBIO with late-stage pipeline (RGX-202 for DMD, RGX-314 retinal therapy partnered with AbbVie).
• Builds on REGENXBIO's own May 2026 positive pivotal Phase 3 AFFINITY DUCHENNE topline for RGX-202 (met primary microdystrophin endpoint with strong functional trends).
• Recent conference comments (e.g., Ram Palanki at CTS) noted big pharma partnering interest in small-caps with clear regulatory path, strong safety, and transparency.
• High short interest (~14% of float) and options activity likely amplified the move via short covering and momentum buying.
• No standalone REGENXBIO press release on June 17; sector sympathy and rebound from post-earnings weakness appear primary drivers.

https://finviz.com/stock?t=RGNX&p=d