CNM-Au8

Clene received FDA guidance to use EAP data for CNM-Au8's ALS treatment approval, emphasizing NfL biomarker analysis. Planning Phase 3 RESTORE-ALS trial and data submission by mid-2025. CNM-Au8 shows survival benefits and safety, aiming to meet ALS patients' needs.

Clene received FDA guidance on an accelerated approval pathway for CNM-Au8 in ALS, recommending leveraging additional NfL data from EAPs and the HEALEY ALS Platform Trial. Clene plans to submit an NDA in mid-2025, incorporating EAP NfL biomarker analyses, and commence the RESTORE-ALS Phase 3 trial before NDA submission.

Clene (CLNN) announced the FDA outlined a potential accelerated approval path for its CNM-Au8 ALS treatment, based on additional biomarker data. This could speed up approval, enhance Clene's market position, and benefit ALS treatment stakeholders. Clene's YTD Price Performance: -19.93%, Market Cap: $37.9M.

Clene Inc. received FDA guidance for an accelerated approval pathway for CNM-Au8® in ALS, recommending additional Neurofilament Light (NfL) data from Expanded Access Protocols and HEALEY ALS Platform Trial. Key developments include planned NDA submission in mid-2025, additional NfL biomarker analyses by Q2 2025, and commencement of confirmatory Phase 3 RESTORE-ALS trial before NDA submission, with demonstrated 78% risk reduction in time to death and strong safety profile.

Clene plans to submit an NDA for ALS in mid-2025, incorporating NfL biomarker analyses from EAPs. The FDA recommends leveraging additional NfL data from EAPs and the HEALEY ALS Platform Trial to support earlier findings and suggests a follow-up meeting to discuss analyses for accelerated approval.

Clene Inc. received FDA guidance on a potential accelerated approval pathway for CNM-Au8 in ALS, following a November 1 meeting where additional data was presented. The FDA recommended leveraging data from ongoing compassionate use EAPs to substantiate CNM-Au8's effect on NfL decline. Clene plans to submit additional NfL biomarker data by Q2 2025 and commence the Phase 3 RESTORE-ALS trial before NDA submission.

FDA advises Clene to use additional Neurofilament Light (NfL) data from EAPs and the HEALEY ALS Platform Trial for CNM-Au8's ALS treatment, aiming for accelerated approval. Clene plans NDA submission by mid-2025, including EAP NfL analyses, and starts Phase 3 RESTORE-ALS trial to evaluate CNM-Au8's survival benefits.

The HEALEY ALS Platform Trial, launched in 2020, aimed to accelerate ALS treatment development. Despite challenges and mixed results, Clene Nanomedicine and Prilenia Therapeutics are advancing their treatments based on positive secondary endpoint data. The trial's innovative, patient-centric approach and efficiency in testing multiple drugs simultaneously mark a significant step in ALS research.

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