Services: Oncolytic immunotherapies, RP1 for anti-PD1 failed melanoma, cancer immunotherapy
Q2 2026 earnings call
Oncolytic immunotherapy developer Replimune eliminated 224 positions (~60% of its workforce) across its Woburn headquarters and Framingham manufacturing facility after receiving a second FDA Complete Response Letter (CRL) for its lead melanoma candidate RP1 (vusolimogene oderparepvec) plus nivolumab.
Delivering therapeutics directly to tumors, as with Replimune's recently approved Tudriqev and Amgen's Imlygic, holds advantages especially when cancer is caught early, but challenges remain before the approach becomes a mainstay in treatment.
A CBER official overruled the review team's rejection of Replimune's new melanoma drug, raising questions about FDA decision-making.
Article from Fierce Pharma about FDA docs shed light on contentious nod for Replimune's Trudiqev.
Replimune’s melanoma drug would have been rejected again if not for senior CBER official
Replimune melanoma drug snags coveted FDA approval after yearlong clash, two rejections
Replimune melanoma drug wins support of FDA panel
Replimune to ride wave of physician support to launch advanced melanoma therapy
Third time’s the charm for Replimune as melanoma drug earns FDA greenlight
FDA reviewers criticize Replimune drug; ProMIS climbs on Alzheimer's data
Replimune overcomes ‘messy data’ to secure positive adcomm vote for melanoma therapy
Replimune’s twice-rejected melanoma drug prevails in FDA adcomm
Capricor and Replimune prep for FDA adcomms, Q2 earnings roll on, Sarepta’s new leader, more
Capricor and Replimune prep for FDA adcomms, Q2 earnings roll on, Sarepta’s new leader, more. Reported by BioSpace on 2026-07-29.
FDA reminds investors that re-evaluations don’t equal new conclusions. Just ask Capricor and Replimune
FDA reminds investors that re-evaluations don’t equal new conclusions. Just ask Capricor and Replimune. Reported by Endpoints News on 2026-07-28.
FDA staff say Replimune's pivotal melanoma trial failed to prove RP1 works, pushing down stock
FDA staff say Replimune's pivotal melanoma trial failed to prove RP1 works, pushing down stock. Reported by Endpoints News on 2026-07-28.