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Replimune Posts $69.8 Million Q1 Loss as TUDRIQEV Approval Nears Commercial Launch

Replimune Group reported a net loss of $69.8 million, or $0.72 per basic and diluted share, for its fiscal first quarter ended June 30, 2026. The company held $…

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Replimune Posts $69.8 Million Q1 Loss as TUDRIQEV Approval Nears Commercial Launch
Article image: Replimune Posts $69.8 Million Q1 Loss as TUDRIQEV Approval Nears Commercial Launch

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Excerpts from the article

  • Replimune Group reported a net loss of $69.8 million, or $0.72 per basic and diluted share, for its fiscal first quarter ended June 30, 2026. The…
  • The FDA granted accelerated approval to TUDRIQEV in combination with nivolumab for adults with unresectable advanced cutaneous melanoma following…
  • Research and development expense was $49.3 million, compared with $57.8 million a year earlier. Selling, general and administrative expense was $19.0…

Replimune Group reported a net loss of $69.8 million, or $0.72 per basic and diluted share, for its fiscal first quarter ended June 30, 2026. The company held $195.3 million in cash, cash equivalents and short-term investments at quarter-end.

The FDA granted accelerated approval to TUDRIQEV in combination with nivolumab for adults with unresectable advanced cutaneous melanoma following progression on a PD-1 antibody-based regimen. Replimune expects product to be in the U.S. market within 60 days.

Research and development expense was $49.3 million, compared with $57.8 million a year earlier. Selling, general and administrative expense was $19.0 million, compared with $32.6 million a year earlier.

Replimune completed a $150 million underwritten offering priced at $12.06 per share, netting $141.0 million in proceeds. The offering closed on August 11, 2026.

Michelle DiNapoli will join as chief commercial officer effective August 18, 2026. The Phase 3 IGNYTE-3 confirmatory study is actively enrolling, with its primary overall-survival endpoint expected to read out in 2030.

Insiders have sold shares on 12 occasions over the past six months with no purchases recorded. CEO Sushil Patel sold 76,665 shares for an estimated $699,858; CFO Emily Luisa Hill sold 19,260 shares for an estimated $188,165; CMO Konstantinos Xynos sold 25,470 shares for an estimated $219,704.

A securities class action lawsuit covers purchasers between October 20, 2025 and April 10, 2026, alleging that FDA resubmission communications were misleading while study-design concerns remained unresolved. The lead plaintiff deadline is October 5, 2026.