Replimune Resubmits Melanoma Drug For Fda Approval

By themelower On Apr 23, 2026

Replimune Resubmits Melanoma Drug For Fda Approval Woburn, mass., april 10, 2026 (globe newswire) replimune group, inc. (nasdaq: repl), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the company received a complete response letter (crl) from the u.s. food and drug administration (fda) for the company’s biologics license application (bla) for rp1 in combination. The pdufa date set by the fda is april 10, 2026 based on a class ii resubmission timeline. “we are pleased the agency has accepted the resubmission of our bla for rp1,” said sushil patel, ph.d., ceo of replimune.

Novel Replimune Rp2 Treatment For Metastatic Uveal Melanoma A Cure In Today, replimune group announced that the us fda has accepted its resubmission of the biologics license application (bla) for rp1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on an anti–pd 1 containing regimen. After rejecting replimune’s melanoma drug rp1 this summer, the fda has accepted the biotech’s resubmission of an approval application. the federal agency said it expects to reach a decision on or. Replimune receives breakthrough therapy designation for rp1 and submits rp1 biologics license application to the fda under the accelerated approval pathway november 21, 2024. Replimune group announced that the fda has accepted its biologics license application (bla) resubmission for rp1, the company’s lead oncolytic immunotherapy product candidate, for the treatment of advanced melanoma.

Replimune Soars Upon Fda Resubmission For Advanced Melanoma Drug Biospace Replimune receives breakthrough therapy designation for rp1 and submits rp1 biologics license application to the fda under the accelerated approval pathway november 21, 2024. Replimune group announced that the fda has accepted its biologics license application (bla) resubmission for rp1, the company’s lead oncolytic immunotherapy product candidate, for the treatment of advanced melanoma. In a reversal of course, replimune announced monday that the fda has accepted a resubmission for rp1 in advanced melanoma, a month after setting expectations low for the drug’s future. The company said monday that the fda accepted its application for rp1 in combination with opdivo and set an april 10 pdufa date. Replimune (nasdaq: repl) announced that the u.s. food and drug administration has accepted the bla resubmission for rp1 in combination with nivolumab to treat advanced melanoma in patients who progress on an anti‑pd‑1 containing regimen. The us food and drug administration (fda) has issued a complete response letter (crl) to replimune group’s biologics licence application (bla) concerning the rp1 therapy in combination with nivolumab for advanced melanoma. the decision affects replimune’s lead product candidate, which is based on a genetically engineered herpes simplex virus intended to stimulate an anti tumour immune.

Replimune Soars Upon Fda Resubmission For Advanced Melanoma Drug Biospace In a reversal of course, replimune announced monday that the fda has accepted a resubmission for rp1 in advanced melanoma, a month after setting expectations low for the drug’s future. The company said monday that the fda accepted its application for rp1 in combination with opdivo and set an april 10 pdufa date. Replimune (nasdaq: repl) announced that the u.s. food and drug administration has accepted the bla resubmission for rp1 in combination with nivolumab to treat advanced melanoma in patients who progress on an anti‑pd‑1 containing regimen. The us food and drug administration (fda) has issued a complete response letter (crl) to replimune group’s biologics licence application (bla) concerning the rp1 therapy in combination with nivolumab for advanced melanoma. the decision affects replimune’s lead product candidate, which is based on a genetically engineered herpes simplex virus intended to stimulate an anti tumour immune.

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Replimune co-founder calls FDA rejection of melanoma drug ‘unfair’

Replimune co-founder calls FDA rejection of melanoma drug ‘unfair’

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