CLNN

In the last week, the United States market has stayed flat, yet it has seen a remarkable 25% increase over the past year with earnings forecasted to grow by 17% annually. In this thriving environment, growth companies with high insider ownership can be particularly appealing as they often indicate strong confidence from those closest to the business in its potential for continued success. Click here to see the full list of 187 stocks from our Fast Growing US Companies With High Insider Ownership screener. Below we spotlight a couple of our favorites from our exclusive screener. Simply Wall St Growth Rating: ★★★★★☆ Overview: Aeluma, Inc. develops optoelectronic and electronic devices for sensing, communication, and computing applications in the United States with a market cap of $488.06 million. Operations: The company's revenue is primarily derived from its Semiconductor Equipment and Services segment, which generated $5.23 million. Insider Ownership: 25.8% Earnings Growth Forecast: 68.6% p.a. Aeluma is positioned for significant growth with forecasted revenue expansion of 77% annually, outpacing the US market. Despite a volatile share price and recent net losses, its strategic focus on high-growth sectors like AI infrastructure and quantum technologies is bolstered by substantial U.S. government contracts exceeding US$4 million. The company's innovative quantum dot laser platform, supported by NASA awards, enhances its competitive edge in photonics integration. However, low projected return on equity remains a concern. Click to explore a detailed breakdown of our findings in Aeluma's earnings growth report. Our valuation report here indicates Aeluma may be overvalued. Simply Wall St Growth Rating: ★★★★☆☆ Overview: STAAR Surgical Company designs, develops, manufactures, and sells phakic implantable lenses and accessory delivery systems for the eye, with a market cap of approximately $1.40 billion. Operations: The company's revenue is primarily generated from its ophthalmic surgical products, totaling $239.44 million. Insider Ownership: 26.2% Earnings Growth Forecast: 71.6% p.a. STAAR Surgical's growth potential is underscored by its forecasted revenue increase of 11.8% annually, slightly above the US market average. Recent earnings showed significant improvement with sales reaching US$93.52 million, a substantial rise from the previous year, and a shift to n...

Over the last 7 days, the United States market has risen by 1.1%, contributing to an impressive 27% climb over the past year, with earnings forecasted to grow by 17% annually. In this thriving environment, companies that exhibit high growth potential and significant insider ownership can be particularly appealing, as they often indicate strong confidence from those closest to the business. Click here to see the full list of 181 stocks from our Fast Growing US Companies With High Insider Ownership screener. Let's take a closer look at a couple of our picks from the screened companies. Simply Wall St Growth Rating: ★★★★☆☆ Overview: Evolus, Inc. is a performance beauty company that provides products in the cash-pay aesthetic market across the United States, Canada, Europe, and Australia with a market cap of $442.54 million. Operations: The company's revenue segment focuses on delivering medical aesthetic products to the cash-pay aesthetic market, generating $301.79 million. Insider Ownership: 11.1% Earnings Growth Forecast: 66.7% p.a. Evolus, Inc. is poised for significant growth with its forecasted profitability within three years and revenue growth expected to outpace the broader US market at 14.4% annually. Recent earnings show a narrowing net loss, and the company anticipates annual revenues between US$327 million and US$337 million for 2026. The upcoming European launch of Estyme marks an international expansion in dermal fillers, potentially enhancing revenue streams despite historically volatile share prices and negative shareholders' equity concerns. Click here and access our complete growth analysis report to understand the dynamics of Evolus. Our expertly prepared valuation report Evolus implies its share price may be lower than expected. Simply Wall St Growth Rating: ★★★★★★ Overview: Upstart Holdings, Inc. operates a cloud-based AI lending platform in the United States and has a market cap of approximately $2.58 billion. Operations: The company's revenue is primarily derived from its personal lending segment, which generated $1.01 billion. Insider Ownership: 12.8% Earnings Growth Forecast: 58.5% p.a. Upstart Holdings is positioned for robust growth, with earnings projected to rise significantly at 58.5% annually, outpacing the US market. Despite a recent net loss of US$6.65 million in Q1 2026, insider activity indicates more buying than selling over...

After successful completion of FDA Type C meeting, Clene expects to submit an NDA for CNM-Au8® under the accelerated approval pathway in the third quarter of 2026 In January 2026, Clene completed an oversubscribed registered direct offering totaling over $28 million, including an initial tranche of more than $6 million and two additional tranches totaling over $22 million tied to regulatory milestones In May 2026, Clene amended its existing $10 million convertible debt facility, extending maturity by six months to August 2027 and eliminating required monthly principal and interest payments before maturity In May 2026, Clene completed a $7 million underwritten registered direct offering with a single investor SALT LAKE CITY, May 14, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late-stage clinical biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced its first quarter 2026 financial results and provided recent updates on its CNM-Au8 programs. “We were encouraged by the constructive dialogue during our recent Type C meeting with the FDA and appreciate the Agency’s engagement as we advance toward a planned NDA submission for CNM-Au8 under the accelerated approval pathway for patients with ALS,” said Rob Etherington, President and CEO of Clene. “People living with ALS continue to need additional treatment options, and we believe CNM-Au8 has the potential to restore and protect neuronal health and function, leading to improved survival. We look forward to continuing to work collaboratively with the FDA as the Agency reviews our extensive clinical efficacy and safety data.” First Quarter 2026 and Recent Operating Highlights CNM-Au8 for the treatment of ALS Clene had a successful Type C in-person meeting with the U.S. Food and Drug Administration (FDA) in the first quarter of 2026 to discuss the statistically significant reductions in neurofilament light (NfL), including the relationship between the magnitude of NfL reduction and clinical benefits, including longer survival in participants treated with CNM-Au8. During the meeting, and as confirmed in the final meeting minutes, the FDA stated that the “proposed data may be capable o...

Over the last 7 days, the United States market has risen by 1.5%, contributing to a remarkable 26% climb over the past year, with earnings forecasted to grow by 17% annually. In this flourishing environment, growth companies with high insider ownership can be particularly appealing as they often indicate strong confidence from those closest to the business and potential for substantial earnings expansion. Click here to see the full list of 185 stocks from our Fast Growing US Companies With High Insider Ownership screener. Let's explore several standout options from the results in the screener. Simply Wall St Growth Rating: ★★★★★☆ Overview: Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing chimeric antigen receptor cell therapy for light chain amyloidosis and immune-mediated diseases, with a market cap of $525.88 million. Operations: Revenue Segments (in millions of $): null Insider Ownership: 12.8% Earnings Growth Forecast: 63.4% p.a. Immix Biopharma is a growth-focused company with high insider ownership, currently navigating financial challenges with a reported net loss of US$10.09 million for Q1 2026. Despite this, its revenue is forecasted to grow significantly faster than the US market at 56.6% annually, driven by promising developments like NXC-201 for AL Amyloidosis. The company anticipates profitability within three years, although it has experienced substantial shareholder dilution and share price volatility recently. Get an in-depth perspective on Immix Biopharma's performance by reading our analyst estimates report here. Our valuation report here indicates Immix Biopharma may be overvalued. Simply Wall St Growth Rating: ★★★★★☆ Overview: Rumble Inc. operates a video sharing and cloud services platform across the United States, Canada, and internationally, with a market cap of approximately $2.77 billion. Operations: The company's revenue is generated from its Internet Software & Services segment, amounting to $100.62 million. Insider Ownership: 35.9% Earnings Growth Forecast: 56.8% p.a. Rumble Inc. exhibits high insider ownership and is positioned for substantial growth, with revenue forecasted to expand at 42.5% annually, outpacing the US market. Recent initiatives like the OpenClaw Starter package on Rumble Cloud highlight its innovative approach in AI infrastructure. Despite a history of volatility and fin...

The United States market has recently experienced a notable upswing, climbing 3.6% in the last week and showing a robust 39% increase over the past year, with earnings projected to grow by 16% annually in the coming years. In this favorable environment, growth companies with high insider ownership can be particularly appealing as they often demonstrate strong confidence from those who know the business best and have vested interests in its success. Click here to see the full list of 202 stocks from our Fast Growing US Companies With High Insider Ownership screener. Let's take a closer look at a couple of our picks from the screened companies. Simply Wall St Growth Rating: ★★★★☆☆ Overview: Clearfield, Inc. designs, manufactures, and distributes fiber management, protection, and delivery products globally with a market cap of $415.12 million. Operations: The company's revenue segment is primarily derived from its fiber management, protection, and delivery products, totaling $154.78 million. Insider Ownership: 18.3% Earnings Growth Forecast: 61.1% p.a. Clearfield's insider ownership aligns with its growth prospects, as earnings are forecast to grow significantly at 61.1% annually, outpacing the US market. Despite recent losses, Clearfield became profitable this year and expects net sales between US$160 million and US$170 million for fiscal 2026. Substantial insider buying occurred over the past three months, reflecting confidence in future performance. Recent presentations at major industry events highlight ongoing efforts to strengthen market presence and investor relations. Unlock comprehensive insights into our analysis of Clearfield stock in this growth report. In light of our recent valuation report, it seems possible that Clearfield is trading beyond its estimated value. Simply Wall St Growth Rating: ★★★★★☆ Overview: Alphatec Holdings, Inc. is a medical technology company that focuses on designing and developing technologies for the surgical treatment of spinal disorders, with a market cap of approximately $1.68 billion. Operations: The company generates revenue primarily from its Medical Products segment, which accounted for $764.16 million. Insider Ownership: 10.4% Earnings Growth Forecast: 56.9% p.a. Alphatec Holdings' insider ownership supports its growth trajectory, with earnings projected to grow significantly at 56.89% annually and revenue expected...

The United States market has experienced a notable upswing, climbing 4.4% in the last week and showing a robust 32% increase over the past year, with earnings forecasted to grow by 16% annually. In this thriving environment, identifying growth companies with high insider ownership can be particularly appealing as they often signal confidence from those closest to the business and potential alignment with shareholder interests. Click here to see the full list of 202 stocks from our Fast Growing US Companies With High Insider Ownership screener. We're going to check out a few of the best picks from our screener tool. Simply Wall St Growth Rating: ★★★★☆☆ Overview: Loar Holdings Inc. designs, manufactures, and sells aerospace and defense components for aircraft and systems both in the United States and internationally, with a market cap of $6.19 billion. Operations: The company generates revenue of $496.28 million from its aerospace and defense segments, focusing on components for aircraft and related systems in both domestic and international markets. Insider Ownership: 17.6% Earnings Growth Forecast: 24.4% p.a. Loar Holdings exhibits strong growth potential with earnings forecasted to grow significantly at 24.4% annually, outpacing the US market. Recent results show a substantial increase in net income and sales for both the fourth quarter and full year 2025, reflecting robust performance. Insider confidence is evident as more shares were bought than sold recently. However, challenges persist with low future return on equity and debt not well covered by operating cash flow. Navigate through the intricacies of Loar Holdings with our comprehensive analyst estimates report here. The valuation report we've compiled suggests that Loar Holdings' current price could be inflated. Simply Wall St Growth Rating: ★★★★★☆ Overview: Paymentus Holdings, Inc. offers cloud-based bill payment technology and solutions both in the United States and internationally, with a market cap of approximately $3.22 billion. Operations: The company generates revenue from its cloud-based bill payment technology and solutions, with services to financial companies amounting to $1.20 billion. Insider Ownership: 30.6% Earnings Growth Forecast: 24.6% p.a. Paymentus Holdings demonstrates strong growth potential with earnings expected to rise significantly at 24.6% annually, exceeding the US market...

In the last week, the United States market has stayed flat, yet it has risen by 16% over the past year with expectations of a 15% annual earnings growth in the coming years. In this context, identifying growth companies with high insider ownership can be advantageous as they often align management interests with shareholder value and may capitalize on favorable market conditions. Click here to see the full list of 205 stocks from our Fast Growing US Companies With High Insider Ownership screener. Let's dive into some prime choices out of the screener. Simply Wall St Growth Rating: ★★★★★☆ Overview: Krystal Biotech, Inc. is a commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing genetic medicines for diseases with high unmet medical needs in the United States, with a market cap of $7.22 billion. Operations: The company's revenue is primarily derived from its genetic medicines aimed at addressing diseases with high unmet medical needs, totaling $389.13 million. Insider Ownership: 10% Earnings Growth Forecast: 28.9% p.a. Krystal Biotech demonstrates strong growth potential, with earnings forecasted to grow significantly at 28.9% annually, outpacing the US market. Recent earnings results showed substantial improvement, with full-year net income reaching US$204.83 million compared to US$89.16 million the previous year. The FDA's RMAT designation for KB707 highlights promising developments in their pipeline, particularly for advanced non-small cell lung cancer treatment. Despite trading below fair value estimates and analyst price targets, insider trading activity remains stable over recent months. Click to explore a detailed breakdown of our findings in Krystal Biotech's earnings growth report. Our valuation report here indicates Krystal Biotech may be undervalued. Simply Wall St Growth Rating: ★★★★★☆ Overview: Klaviyo, Inc. offers a cloud-based software-as-a-service platform across various regions including the Americas, Asia-Pacific, Europe, the Middle East, and Africa with a market cap of $5.78 billion. Operations: The company's revenue primarily comes from its Internet Software segment, which generated $1.23 billion. Insider Ownership: 36.6% Earnings Growth Forecast: 81.7% p.a. Klaviyo is positioned for growth with its expanding product capabilities, such as Composer and enhanced Shopify integration, driv...

Over the last 7 days, the United States market has experienced a 3.5% drop, yet it has risen by 14% over the past year with earnings projected to grow by 15% annually in the coming years. In this environment, growth companies with high insider ownership can be particularly appealing as they may align management's interests with shareholders and potentially drive significant earnings growth. Click here to see the full list of 205 stocks from our Fast Growing US Companies With High Insider Ownership screener. We'll examine a selection from our screener results. Simply Wall St Growth Rating: ★★★★☆☆ Overview: Merchants Bancorp is a diversified bank holding company operating in the United States, with a market cap of approximately $1.94 billion. Operations: The company generates revenue through its Banking segment with $240.62 million, Mortgage Warehousing at $149.20 million, and Multi-Family Mortgage Banking contributing $173.81 million. Insider Ownership: 36.1% Earnings Growth Forecast: 20.2% p.a. Merchants Bancorp, with strong insider ownership, is positioned for growth with earnings projected to rise significantly at 20.2% annually, outpacing the US market. Despite a recent dip in net income and earnings per share, it trades below its estimated fair value and offers good relative value compared to peers. Recent inclusion in major indices like the S&P 1000 highlights its growing prominence. The company also announced a $100 million share buyback program valid through 2027. Click to explore a detailed breakdown of our findings in Merchants Bancorp's earnings growth report. Our comprehensive valuation report raises the possibility that Merchants Bancorp is priced lower than what may be justified by its financials. Simply Wall St Growth Rating: ★★★★★★ Overview: Better Home & Finance Holding Company operates as a homeownership company in the United States with a market cap of approximately $504.35 million. Operations: The company's revenue primarily comes from its Home Finance segment, generating $157.26 million, and its Banking segment, contributing $7.61 million. Insider Ownership: 19.9% Earnings Growth Forecast: 97.4% p.a. Better Home & Finance Holding, with significant insider ownership, is poised for growth as it leverages innovative strategies like token-backed mortgages in partnership with Coinbase. The company is forecast to achieve high revenue growth of...

In-person Type C FDA meeting scheduled by end of the first quarter of 2026 to discuss the latest CNM-Au8® data submitted; Clene expects formal written meeting minutes early in the second quarter 2026 Oversubscribed registered direct offering of over $28 million priced above market Initial financing tranche of over $6 million, which will provide cash runway to the end of the third quarter enabling funding through potential NDA acceptance decision by the FDA Completion of this financing through its three tranches is expected to provide the Company with sufficient capital into 2027 SALT LAKE CITY, March 12, 2026 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced its full year 2025 financial results and provided recent updates on its CNM-Au8 programs. “Our next key milestone is the upcoming Type C face-to-face meeting with the U.S. Food and Drug Administration (FDA) on Clene’s biomarker and survival data, which if positive, will facilitate filing of an new drug application (NDA) under an accelerated approval pathway for ALS by the end of the second quarter of 2026,” said Rob Etherington, President and CEO of Clene. “In parallel, we continue to advance plans to initiate our confirmatory Phase 3 trial in ALS, which is required to be “underway” by CNM-Au8 approval in ALS, as well as to continue working with the FDA on the initiation of a Phase 3 clinical trial using cognition as an endpoint in MS. Based on our combined findings to date, we continue to believe that patients across multiple neurodegenerative conditions may benefit from the improved mitochondrial function plus energy metabolism associated with CNM-Au8 treatment.” Fourth Quarter 2025 and Recent Operating Highlights CNM-Au8 for the treatment of ALS Clene expects its Type-C meeting with the FDA will occur before the end of this month. Clene will then await formal written meeting minutes from the agency which are expected early in the second quarter of 2026, after which Clene will publicly announce the outcome of the FDA meeting. Clene plans to file an NDA for CNM-Au8 in ALS...

FDA recommended biomarker analyses show statistically significant reductions in NfL and GFAP in participants treated with CNM-Au8 Biomarker improvements are strongly associated with longer survival, reinforcing CNM-Au8’s potential disease modifying activity Company has requested a Type C meeting in the first quarter of 2026 to present the newly completed analyses supporting a planned NDA submission under the accelerated approval pathway Clene is hosting an investor webcast today at 8:30 am ET SALT LAKE CITY, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene” or the “Company”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced completion of the FDA-recommended biomarker analyses for CNM-Au8® in people living with ALS. The results demonstrate statistically significant reductions in both neurofilament light (NfL) and glial fibrillary acidic protein (GFAP) and provide compelling evidence linking biomarker decline to improved survival. “We followed the FDA’s roadmap — and the data delivered,” said Rob Etherington, President and CEO of Clene. “Statistically significant NfL reductions in more advanced real-world ALS patients; a second independent disease-specific biomarker (GFAP) that moves in lock-step with NfL and is itself statistically significant; and clear evidence in placebo switchers (placebo-to-CNM-Au8) showing that CNM-Au8-treated participant’s biomarkers follow nearly identical trajectories seen in the original active arm during the double-blind treatment phase of the HEALEY ALS Platform Trial. This is a remarkably consistent dataset that makes a strong case for accelerated approval. We look forward to presenting these analyses to the Division in the requested Type C meeting in the first quarter of 2026 and working with the FDA toward an NDA submission for accelerated approval.” The analyses follow FDA recommendations to support the persuasiveness of the original NfL findings observed in the HEALEY ALS Platform Trial by extending the analyses to the NIH-sponsored EAP (NIH-EAP) for CNM-Au8 in ALS. These biomarker findings build on prior constructive FDA interactions in support of a planned NDA s...

As the U.S. Food and Drug Administration (FDA) proposed, Clene is concluding analyses of its ALS biomarker data with completion planned shortly The FDA advised Clene to request a Type C meeting to review these further ALS biomarker data analyses The Company plans to submit a New Drug Application (NDA) in the first quarter of 2026 under an accelerated approval pathway The Company expects to have the first patient dosed in the confirmatory Phase 3 RESTORE-ALS trial of CNM-Au8 in the first half of 2026 The FDA and Clene participated in a Type B end of Phase 2 meeting in the third quarter of 2025 to discuss the Company’s MS clinical development program and ongoing plans for MS development of CNM-Au8 Cash and cash equivalents of $7.9 million as of September 30, 2025 Cash runway extended into the second quarter of 2026, including $1.2 million additionally raised following the third quarter close SALT LAKE CITY, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene” or the “Company”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced its third quarter 2025 financial results and provided recent updates on its CNM-Au8 programs. “The three potential biomarker paths that could be leveraged to increase the persuasiveness of our ALS data, as outlined by the FDA, include: a) the NfL analysis of our ongoing NIH-sponsored Expanded Access Program (EAP); b) additional ALS disease-specific biomarker changes (in addition to NfL) from the HEALEY ALS Platform Trial; and c) NfL analysis of subjects in the open-label extension (OLE) of the HEALEY ALS Platform Trial who were initially treated with placebo during the placebo-controlled portion of the trial and then received CNM-Au8 during the OLE,” said Rob Etherington, President and CEO of Clene. “The Company anticipates completing these data analyses shortly which could support the filing of an NDA using the accelerated approval pathway.” Third Quarter 2025 and Recent Operating Highlights CNM-Au8 for the treatment of ALS Clene held a second Type C meeting with the FDA to review the long-term survival benefit from CNM-Au8 30 mg treatment compared to concurrently randomized cont...

Explore Clene's Fair Values from the Community and select yours Net loss: US$7.42m (loss widened by 9.3% from 2Q 2024). US$0.78 loss per share. AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 52%. Earnings per share (EPS) also missed analyst estimates by 65%. Looking ahead, revenue is forecast to grow 70% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 1.6% from a week ago. Don't forget that there may still be risks. For instance, we've identified 5 warning signs for Clene (4 shouldn't be ignored) you should be aware of. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.