Opus Genetics Unlocks Key Milestone With US FDA Alignment on OPGx-LCA5 Phase 3, Wedbush Says
Opus Genetics' (IRD) alignment with the US Food and Drug Administration on the design of the registrational phase 3 study of OPGx-LCA5, an investigational gene therapy for a rare inherited retinal disease, marks an important milestone, Wedbush Securities said Monday. The finalization of the study size at eight patients and the potential submission of a biologics license application on the primary endpoint analysis at six months confirm the FDA's support for an expedited pathway, reflecting an urgent unmet medical need and promising clinical trial data, the brokerage said. Wedbush believes the regulatory progress bodes well for OPGx-LCA5's clinical success, and positive data from the phase 3 study will provide important evidence for Opus' overall inherited retinal disease pipeline, which now includes five programs, according to the note. Wedbush kept an outperform rating on Opus Genetics with a price target of $10.
Opus Genetics' (IRD) alignment with the US Food and Drug Administration on the design of the registrational phase 3 study of OPGx-LCA5, an investigational gene therapy for a rare inherited retinal disease, marks an important milestone, Wedbush Securities said Monday.
The finalization of the study size at eight patients and the potential submission of a biologics license application on the primary endpoint analysis at six months confirm the FDA's support for an expedited pathway, reflecting an urgent unmet medical need and promising clinical trial data, the brokerage said.
Wedbush believes the regulatory progress bodes well for OPGx-LCA5's clinical success, and positive data from the phase 3 study will provide important evidence for Opus' overall inherited retinal disease pipeline, which now includes five programs, according to the note.
Wedbush kept an outperform rating on Opus Genetics with a price target of $10.