ACHV READ THE FULL ACHV RESEARCH REPORT Achieve Life Sciences, Inc. (NASDAQ:ACHV) reported 2024 results sharing progress with ...

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Comprehensive clinical pharmacology and CMC studies also strengthen the NDA submission. H3 K27M-mutant gliomas are highly aggressive, impacting more than 2,000 patients annually in the United States.

New leadership appointments, including Dr. Kristen Slaoui and Nancy Phelan to the Board and Mark Oki as CFO, are expected to support the NDA submission and commercialization efforts. Achieve also ...

Anticipated submission of New Drug Application (NDA) to the FDA in April 2025, signaling progress in the regulatory process. ET-600 would become the only FDA-approved oral liquid formulation of ...

The NDA submission includes data from two Phase 3 pivotal trials of Epioxa, which both successfully achieved the pre-specified primary efficacy endpoints and demonstrated favorable tolerability ...

Achieve Life Sciences, Inc. (NASDAQ:ACHV) reported 2024 results sharing progress with the new drug application (NDA) for cytisinicline and narrowing its anticipated submission date to late 2Q ...