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Replimune melanoma drug wins support of FDA panel

The positive vote came despite persistent concerns from FDA scientists and positions the company to bounce back from two earlier rejections.

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biopharmadive.comStai leggendo4 g fa

Replimune melanoma drug wins support of FDA panel

The positive vote came despite persistent concerns from FDA scientists and positions the company to bounce back from two earlier rejections.

originale

Timeline cronologica

martedì 28 luglio 2026·medpagetoday.com
FDA Staff Unconvinced Drug for Melanoma Shows Benefit
Replimune's RP1 faces tough test at upcoming FDA advisory panel meeting
martedì 28 luglio 2026·statnews.com
FDA staff reiterate concerns about Replimune skin cancer treatment
Regulators at the FDA have reiterated concerns that Replimmune does not have adequate data to support an approval of its investigational skin cancer treatment.

benzinga.com

2 g fa

Replimune Skin Cancer Therapy Hopes Revive After Positive FDA Panel Vote - Replimune Group (NASDAQ:REPL)

FDA advisory panel backed Replimune's RP1 melanoma data ahead of the agency's August 2 decision despite earlier staff criticism.

Leggi questa versione → originale

medpagetoday.com5 g fa

FDA Staff Unconvinced Drug for Melanoma Shows Benefit

Replimune's RP1 faces tough test at upcoming FDA advisory panel meeting

Leggi questa versione → originale

endpoints.news3 g fa

Replimune defends melanoma drug decisions to adcomm, parrying FDA skepticism

Replimune defends its single-arm RP1 melanoma trial data as an FDA advisory panel prepares to vote on whether results are interpretable and RP1 works.

Leggi questa versione → originale

statnews.com3 g fa

FDA expert committee votes in favor of Replimune’s melanoma treatment

STAT is live-blogging a meeting of FDA experts to review Replimune’s experimental melanoma drug, RP1.

Leggi questa versione → originale

martedì 28 luglio 2026·

endpoints.news

FDA staff say Replimune's pivotal melanoma trial failed to prove RP1 works, pushing down stock

FDA staff criticized Replimune's RP1 melanoma drug ahead of an advisory meeting, saying its Phase 2 trial failed to prove efficacy. Shares fell 30%.

martedì 28 luglio 2026·

benzinga.com

Replimune Lead Drug Trial Data Deemed 'Not Interpretable' by FDA Staff - Replimune Group (NASDAQ:REPL)

Replimune shares fall after FDA briefing documents questioned RP1 trial data for advanced melanoma ahead of a key advisory committee meeting.

mercoledì 29 luglio 2026·

biopharmadive.com

FDA reviewers criticize Replimune drug; ProMIS climbs on Alzheimer’s data

Replimune shares plummeted 40% on concerns FDA scientists are still skeptical of its melanoma drug. Elsewhere, investors had a muted reaction to a first-of-its-kind study result.

giovedì 30 luglio 2026·

biopharmadive.com

Replimune melanoma drug wins support of FDA panel

The positive vote came despite persistent concerns from FDA scientists and positions the company to bounce back from two earlier rejections.

giovedì 30 luglio 2026·

statnews.com

Tracking the FDA expert review of Replimune’s melanoma treatment

STAT is live-blogging a meeting of FDA experts to review Replimune’s experimental melanoma drug, RP1.

giovedì 30 luglio 2026·

statnews.com

FDA expert committee votes in favor of Replimune’s melanoma treatment

STAT is live-blogging a meeting of FDA experts to review Replimune’s experimental melanoma drug, RP1.

giovedì 30 luglio 2026·

medpagetoday.com

Twice-Rejected Melanoma Drug Gets Surprise Love From FDA Panel

Vote at odds with FDA reviewers

giovedì 30 luglio 2026·

endpoints.news

Replimune defends melanoma drug decisions to adcomm, parrying FDA skepticism

Replimune defends its single-arm RP1 melanoma trial data as an FDA advisory panel prepares to vote on whether results are interpretable and RP1 works.

venerdì 31 luglio 2026·

statnews.com

Pharmalittle: We're reading about a Novo setback, support for Replimune's melanoma drug, and more

An FDA advisory panel recommended use of an experimental Replimune treatment for advanced melanoma that the agency has rejected twice

venerdì 31 luglio 2026·

benzinga.com

Replimune Skin Cancer Therapy Hopes Revive After Positive FDA Panel Vote - Replimune Group (NASDAQ:REPL)

FDA advisory panel backed Replimune's RP1 melanoma data ahead of the agency's August 2 decision despite earlier staff criticism.

Replimune melanoma drug wins support of FDA panel

Timeline cronologica

FDA Staff Unconvinced Drug for Melanoma Shows Benefit

FDA staff reiterate concerns about Replimune skin cancer treatment

Replimune Skin Cancer Therapy Hopes Revive After Positive FDA Panel Vote - Replimune Group (NASDAQ:REPL)

FDA Staff Unconvinced Drug for Melanoma Shows Benefit

Replimune defends melanoma drug decisions to adcomm, parrying FDA skepticism

FDA expert committee votes in favor of Replimune’s melanoma treatment

FDA staff say Replimune's pivotal melanoma trial failed to prove RP1 works, pushing down stock

Replimune Lead Drug Trial Data Deemed 'Not Interpretable' by FDA Staff - Replimune Group (NASDAQ:REPL)

FDA reviewers criticize Replimune drug; ProMIS climbs on Alzheimer’s data

Replimune melanoma drug wins support of FDA panel

Tracking the FDA expert review of Replimune’s melanoma treatment

FDA expert committee votes in favor of Replimune’s melanoma treatment

Twice-Rejected Melanoma Drug Gets Surprise Love From FDA Panel

Replimune defends melanoma drug decisions to adcomm, parrying FDA skepticism

Pharmalittle: We're reading about a Novo setback, support for Replimune's melanoma drug, and more

Replimune Skin Cancer Therapy Hopes Revive After Positive FDA Panel Vote - Replimune Group (NASDAQ:REPL)