Regenxbio RGNX: FDA reversal on DMD filing shifts risk profile

Seeking Alpha analyst Edmund Ingham upgraded Regenxbio (NASDAQ:RGNX) to Strong Buy from Hold, citing an FDA course reversal on the company's NAVSUNLI program and the potential for an accelerated approval filing in Duchenne muscular dystrophy (DMD).

The earlier Hold rating followed a complete response letter for RGX-121 in MPS II and mixed results from the RGX-202 DMD trial. The reversal changes the risk-reward calculus, Ingham said.

NAVSUNLI is Regenxbio's treatment for wet age-related macular degeneration, a market dominated by Eylea and Lucentis. An FDA shift on approval could open a new revenue stream. Separately, an accelerated approval filing for RGX-202 in DMD would compress the timeline to market.

Ingham pointed to the FDA's willingness to reconsider its stance on the wet AMD candidate as a catalyst. The DMD program, if filed under accelerated approval, would bypass a longer Phase 3 readout.

Risks remain. The FDA could reverse again. The DMD filing depends on data from the ongoing trial. Investors should watch for formal FDA feedback on both programs.

Ingham disclosed no stock, option, or derivative position in Regenxbio. He wrote the article for Seeking Alpha without compensation beyond the platform and has no business relationship with the company.