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Clene Announces Regulatory Update After FDA Meeting

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Clene Announces Regulatory Update After FDA Meeting

Elevate Your Investing Strategy:

Clene ( (CLNN) ) has issued an update.

On June 30, 2025, Clene Inc. announced a regulatory update following a constructive Type C meeting with the FDA regarding its neurofilament biomarker analysis plan. The FDA provided supportive feedback on Clene’s proposed statistical analysis plan for its NIH-sponsored Expanded Access Program, which supports ALS patients treated with CNM-Au8®. The company plans to conduct neurofilament light (NfL) biomarker analyses early in the fourth quarter of 2025 and aims to submit a new drug application for ALS under the accelerated approval pathway by the end of 2025. Additionally, Clene confirmed two more FDA meetings in the third quarter of 2025 to discuss ALS survival data and the MS clinical development program, which could further advance its ALS and MS therapeutic initiatives.

The most recent analyst rating on (CLNN) stock is a Buy with a $31.00 price target. To see the full list of analyst forecasts on Clene stock, see the CLNN Stock Forecast page.

Spark’s Take on CLNN Stock

According to Spark, TipRanks’ AI Analyst, CLNN is a Neutral.

Clene’s overall score is impacted most significantly by its poor financial performance, reflecting the company’s financial instability and cash flow challenges. The recent positive corporate events, including Nasdaq compliance and product advancements, offer some optimism. Technical analysis indicates moderate momentum, while a negative valuation highlights ongoing financial struggles.

To see Spark’s full report on CLNN stock, click here.

More about Clene

Clene Inc. is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and multiple sclerosis (MS). The company is based in Salt Lake City, Utah, with research and development and manufacturing operations in Maryland. Its investigational therapy, CNM-Au8®, aims to improve central nervous system cells’ survival and function by targeting mitochondrial function and the NAD pathway while reducing oxidative stress.

Average Trading Volume: 93,156

Technical Sentiment Signal: Sell

Current Market Cap: $33.78M

Find detailed analytics on CLNN stock on TipRanks’ Stock Analysis page.

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