Clene shares hold Buy rating as analyst sees FDA decision impacting time to market

On Friday, Benchmark revised its price target for Clene Inc. (NASDAQ:CLNN), a biopharmaceutical company, reducing it to $84.00 from the previous $90.00, while keeping a Buy rating on the stock. The adjustment follows a recent meeting between Clene's management, key opinion leaders, and the U.S. Food and Drug Administration (FDA) on November 1, 2023, to discuss the potential for an accelerated approval pathway for their drug CNM-Au8, aimed at treating Amyotrophic Lateral Sclerosis (ALS).

During the Type C meeting, Clene presented new data, which included biomarker, clinical, and survival data, related to CNM-Au8. The company is now awaiting the minutes from this FDA meeting. Earlier in August, Clene had shared a glimpse of the new data that was included in the briefing book for the FDA, which Benchmark believes supports the case for CNM-Au8's entry into the FDA's Accelerated Approval program, using neurofilament light chain testing as a surrogate biomarker.

The analyst from Benchmark noted that if the FDA is receptive to the proposed use of biomarker data and survival endpoints, it could positively influence the trial design for CNM-Au8 and potentially shorten the time it takes for the drug to reach the market. This could be a significant development for Clene as it would accelerate the drug's availability to patients suffering from ALS.

The revised price target also takes into account the latest financial report from Clene. The company's third-quarter report, filed as a 10-Q, included new share count assumptions, which played a part in the updated valuation model leading to the lower price target.

Benchmark's updated stance on Clene Inc. reflects the company's ongoing dialogue with the FDA and its impact on the anticipated market entry timeline for CNM-Au8, a key product in Clene's pipeline that could potentially address the needs of ALS patients.

InvestingPro Insights

While Benchmark maintains a bullish outlook on Clene Inc. (NASDAQ:CLNN) with a Buy rating, recent InvestingPro data paints a more nuanced picture of the company's current financial position. The company's market capitalization stands at a modest $32 million, reflecting its early-stage status in the biopharmaceutical industry.

InvestingPro Tips highlight that Clene is "quickly burning through cash" and has "short term obligations exceed[ing] liquid assets," which are common characteristics for biotech companies in the research and development phase. This aligns with the article's focus on the potential accelerated approval pathway for CNM-Au8, as faster market entry could be crucial for the company's financial sustainability.

Additionally, the InvestingPro data shows a significant revenue decline, with a -41.36% growth rate in the last twelve months as of Q3 2024. This, coupled with the InvestingPro Tip that "analysts anticipate sales decline in the current year," underscores the importance of CNM-Au8's development and potential market approval for Clene's future prospects.

It's worth noting that InvestingPro offers 12 additional tips for Clene Inc., providing a more comprehensive analysis for investors interested in the company's financial health and market position.

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