Wedbush Morning Call - Jun 30 2026 7:09AM

研报英文原文证据摘录

Wedbush Morning Call - Jun 30 2026 7:09AM

uit naive subjects. From our view, this still boils down to a review assessment by FDA and with

no disease modifying treatments available in Friedreich's ataxia, we still see need for a novel treatment. We await further

clarity on the potential timing for completion of the full BLA submission package which remains on a 2H26 timeline; however,

our current estimates assume this is done by ~3Q26.

Replimune (REPL)

Rating: NEUTRAL, 12-Month Price Target: $9.00, Price: $11.63

Fiscal Q4 Financials; Preparing for August 2nd PDUFA

REPL reported fiscal fourth quarter and full year FY2026 financials following the recent BLA acceptance and August 2nd

PDUFA for RP1 (vusolimogene oderparepvec) in combination with nivolumab in advanced melanoma, with an AdCom

expected in late July (see our recent note, here). As a reminder, we see a strong chance of approval given the apparent

flexibility from the FDA despite two previous CRLs; importantly, we believe key FDA departures, as well as seemingly positive

interactions between the company and the agency are indicative of a more constructive dialogue. REPL also recently presented

updated IGNYTE 3-year OS data at ASCO 2026; we note this further supports the durability profile, with 47.8% of all treated

patients alive at 3 years, a median OS of 32.9 months, and an 83.5% 3-year survival rate among responders, which is

incrementally supportive ahead of the AdCom. Finally, RP1 continues to be investigated in combination with nivolumab versus

physicians’ choice in patients progressed on ICI in the confirmatory IGNYTE-3 study. Outside of RP1, the registration-directed

REVEAL Phase 2/3 trial of RP2 in metastatic uveal melanoma continues to enroll with the Phase 2/3 transition expected in