Replimune launched TUDRIQEV. Replimune stock fell 1.61 percent.

Published on 10/08/2026 at 22:56 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

TUDRIQEV trial data showed a 24.20 percent response rate in 140 patients. Replimune stock costs EUR 11.59 on October 8, 2026 after EUR 11.78.

Key points in brief

Replimune launched TUDRIQEV in the United States for advanced melanoma on October 1, 2026.
The supporting trial showed a 24.20 percent objective response rate among 140 patients, with a 14.10-month median response duration.
REPL was at EUR 11.59 at Lang & Schwarz on October 8, 2026 at 10:54 p.m. CEST, down 1.61 percent versus EUR 11.78.
The Nasdaq-listed biotechnology company had a market capitalization of USD 1.1 billion and a 52-week range of USD 1.50 to USD 16.33.

REPL, US76029N1063, Illustration mit AI erstellt.

Replimune (ISIN US76029N1063) had TUDRIQEV commercially available in the United States on October 1, 2026, while Replimune stock fell 1.61 percent in the Lang & Schwarz after-hours quote on October 8, 2026. GlobeNewswire reported that healthcare providers could order the therapy for next-day delivery.

What supports the approval?

The accelerated approval rests on the IGNYTE trial, where TUDRIQEV combined with nivolumab produced a 24.20 percent objective response rate among 140 patients. Median response duration reached 14.10 months, giving the launch a clinical measure beyond the commercial milestone, according to GlobeNewswire on October 1, 2026.

The same release identifies IGNYTE-3 as an ongoing Phase 3 confirmatory trial. Continued approval may depend on verification of clinical benefit, leaving execution of that study as a central regulatory condition for the commercial rollout.

Three milestones shape the story

On August 6, 2026, Replimune held an investor call tied to the accelerated approval, with the supporting melanoma cohort involving 140 patients. On August 14, 2026, the company reported fiscal first-quarter 2027 adjusted earnings per share of USD -0.72 against a consensus estimate of USD -0.77, according to Yahoo Finance. On October 1, 2026, TUDRIQEV became commercially available in the United States, extending the sequence from approval to launch.

Next reporting date

The next dated event identified for Replimune is estimated quarterly reporting on November 5, 2026. The Nasdaq-listed biotechnology company is moving into commercialization with 465 employees and a fiscal year ending in March, according to StockAnalysis.

REPL trades below its yearly high

Replimune had a market capitalization of USD 1.1 billion on October 8, 2026, with a Nasdaq 52-week range of USD 1.50 to USD 16.33. Its fiscal first-quarter 2027 adjusted earnings per share of USD -0.72 compared with the USD -0.77 consensus estimate, a difference of USD 0.05, while the company continues to fund commercial and clinical operations.

At Lang & Schwarz, the stock was trading at EUR 11.59 on October 8, 2026 at 10:54 p.m. CEST, down 1.61 percent versus the prior close of EUR 11.78. The further course of trading is shown by the continuously updated real-time quote of Replimune stock.