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Forecast

The analysts' average price target is €44.67 (+1,270.25%). The median is €44.67 (+1,270.25%).

Buy	7
Hold	1
Sell	0

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Clene files for accelerated approval of ALS drug CNM-Au8

Clene announced at the Cantor Fitzgerald Global Healthcare Conference that it plans to submit an NDA for CNM-Au8 with a request for accelerated approval in ALS in Q4 2024. The company highlights positive signals such as a survival benefit, reduced clinical deterioration and a statistically significant 10% reduction in neurofilament light chains, although the primary ALSFRS endpoint was missed. Clene points to a strong safety profile (over 1,250 patient-years), expects additional capital will be needed before launch, and plans a targeted commercial rollout upon approval alongside a parallel phase 3 study, RESTORE-ALS. FDA discussions are ongoing; an accelerated decision could come by summer 2025, and RESTORE-ALS is expected to start in 2025. » More on de.investing.com

Financials

In the last quarter, Clene Inc Ordinary Shares had revenue of €78.86k and net profit of -€11.76m

(EUR)	June 2026	YoY
Revenue	78.86k	244.25%
Gross profit	47.32k	106.55%
Net profit	-11.76m	86.87%
EBITDA	-4.38m	19.08%

Fundamentals

Metric	Value
Market capitalization	€45.85m
Number of shares	14.21m
52-week high/low	€12.06 - €2.70
Dividends	No
Beta	0.92
P/E ratio	-1.02
PEG ratio	0.50
P/B ratio	-1.80
P/S ratio	260.47

Company profile

Clene Inc., a clinical-stage pharmaceutical company, focuses on the discovery, development, and commercialization of novel clean-surfaced nanotechnology (CSN) therapeutics. Its lead drug is CNM-Au8, which is being studied in various clinical trials, including a Phase 2/3 registrational clinical trial for patients with amyotrophic lateral sclerosis (ALS); completed Phase 2 proof of concept clinical trial in patients with early symptomatic ALS; completed two open-label investigator blinded Phase 2 clinical trials on the brain's energy metabolites; ongoing Phase 2 clinical trial for the treatment of visual pathway deficits in chronic optic neuropathy for remyelination in stable relapsing Multiple Sclerosis; and a planned Phase 2 clinical trial for the treatment of patients with Parkinson's Diseases. The company's products also include CNM-AgZn17, a gel polymer suspension of silver and zinc ions that is being developed for the treatment of infectious diseases and to accelerate wound healing; CNM-ZnAg, a broad-spectrum antiviral and antibacterial agent to treat infection disease, such as COVID-19 and to provide immune support for symptom resolution; and CNM-PtAu7, a gold-platinum CSN therapeutic for oncology applications. It also markets and distributes dietary supplements comprising rMetx, an aqueous zinc-silver ion dietary supplement; and KHC46, an aqueous gold dietary supplement of very low-concentration Au nanoparticles. The company is headquartered in Salt Lake City, Utah.