Reports Q3 revenue $108,000, consensus $120,000. “We are pleased to be approaching a meaningful regulatory discussion with the U.S. Food and Drug Administration later in the fourth quarter to elucidate key next steps in our ALS regulatory submission of CNM-Au8,” said Rob Etherington, President and CEO of Clene. “We are hopeful that the consistent survival, delayed time to clinical worsening and strong safety profile with CNM-Au8 treatment from two phase 2 independent trials is sufficiently compelling for FDA to consider an accelerated path forward. The unmet need remains high for treatments to improve and extend life for patients living with this highly debilitating and rapidly progressive condition.”
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Read More on CLNN:
- Clene Reports Third Quarter 2023 Financial Results and Operating Highlights
- Clene awarded $45.1M four-year grant from NINDS for CNM-Au8
- National Institutes of Health Awards $45.1 Million NINDS Grant for CNM-Au8® Study in ALS
- Clene announces publication on CNM-Au8 catalytic mechanism of action
- Clene to Present at Cantor Fitzgerald Annual Global Healthcare Conference
