Curated News
By: NewsRamp Editorial Staff
September 25, 2024

Clene Inc. (NASDAQ: CLNN) to Discuss Lead Candidate CNM-Au8® Biomarker Clinical Data for ALS with FDA Leadership

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Source News Release

TLDR

  • Clene seeks accelerated approval for CNM-Au8, offering a competitive edge in ALS treatment.
  • The FDA will reevaluate Clene's submission, focusing on CNM-Au8 biomarker and clinical data for ALS.
  • CNM-Au8 shows hope for ALS patients by restoring and protecting neurological function.
  • Clene's upcoming FDA meeting will include top officials and key opinion leaders, offering an educational opportunity.

Impact - Why it Matters

This news matters because it highlights the efforts of Clene Inc. to seek an accelerated approval regulatory pathway for a potential treatment for ALS. The upcoming meeting with FDA leadership signifies a critical step in the evaluation and potential approval of CNM-Au8, offering hope to patients with neurodegenerative conditions. The meeting will provide an opportunity for Clene to present important clinical and survival data to FDA officials and key opinion leaders, potentially shaping the future of ALS treatment.

Summary

Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company, are seeking an accelerated approval regulatory pathway for CNM-Au8® for ALS. The FDA has agreed to an in-person meeting to reevaluate Clene’s submission. Lead drug candidate CNM-Au8 has shown promise in restoring and protecting neurological function, giving hope to patients with neurodegenerative conditions. The upcoming FDA meeting will be attended by top FDA officials and key opinion leaders in ALS, biostatistics, and biomarkers, and will focus on the company’s CNM-Au8 biomarker and related clinical and survival data for ALS.

Source Statement

This curated news summary relied on this press release disributed by InvestorBrandNetwork (IBN). Read the source press release here, Clene Inc. (NASDAQ: CLNN) to Discuss Lead Candidate CNM-Au8® Biomarker Clinical Data for ALS with FDA Leadership

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