Replimune Group Inc

News & Events zu Replimune Group Inc (REPL)

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REPL-News

REPL-Events

8/14 17:00

Replimune Files Automatic Mixed Securities Shelf

Replimune files automatic mixed securities shelf

8/10 08:30

Leerink, JPMorgan and Cantor Fitzgerald Jointly Manage Offering

Leerink, JPMorgan and Cantor Fitzgerald are acting as joint book running managers for the offering. The deal priced at its 08/07 close price.

8/6 18:00

Replimune Receives FDA Accelerated Approval for Tudriqev in Melanoma

Replimune announced that the FDA has granted accelerated approval for Tudriqev, previously referred to as RP1, in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression on an anti-PD-1 antibody-based regimen. The IGNYTE trial enrolled 140 patients with 91 patients with at least one non-injected lesion included in the efficacy-evaluable population. In this population, Tudriqev plus nivolumab achieved an objective response rate of 24.2%, with a median duration of response of 14.1 months. Treatment was well tolerated with mostly mild-to-moderate adverse events. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent on verification of clinical benefit in a confirmatory trial.

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