Third Time's the Charm

研报英文原文证据摘录

Third Time's the Charm

Quick Note

June 26, 2026 Replimune (REPL)

Rating: Third Time's the CharmNEUTRAL

Price:

$11.13 REPL announced FDA has accepted its second resubmission of the BLA for RP1

12-Month Price Target: (vusolimogene oderparepvec) in combination with nivolumab for patients with

$6.00 advanced melanoma, and granted a goal date of August 2nd 2026. Of note, the

FDA has notified the company to expect an advisory meeting in late July. REPL

received a CRL on July 22nd 2025 following initial submission and priority review,

Analysts and received a second CRL on April 13th 2026 following a second resubmission (note

Robert Driscoll, Ph.D. here). We see a strong chance of positive approval given the apparent FDA flexibility

(415) 274-6863 and willingness to review the data on an expeditious timeline, which follows theRobert.Driscoll@wedbush.com

departure of key FDA personnel in (chiefly, Makary in May 2026, Prasad in AprilGeoffrey Von Der Ahe

(628) 223-0517 2026, Pazdur in December 2025), and subsequent positive FDA-company dialogue.

geoffrey.vonderahe@wedbush.com REPL had previously pushed back, highlighting inconsistencies with the FDA

regulatory process and communications regarding the initial submissions, and had

publicly requested an AdCom meeting to review the data with KOLs in melanoma.

We continue to believe the profile of RP1/nivo profile overwhelmingly supports

approval despite the single arm nature of IGNYTE – the IGNYTE study evaluated 140

PD-1 refractory melanoma patients treated with RP1 + nivolumab, demonstrating

an ORR of 33.6% and mDOR of 33.7 months, alongside a promising OS of 54% at 3

years, with consistent ORR >25% across subgroups including adjuvant PD-1 (n=36),

Stage IIIb–IVa (n=72) and Stage IVb–IVd (n=68), and prior CTLA-4 (n=65) patients