ATLANTA, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether MoonLake Immunotherapeutics (“MoonLake” or the “Company”) (NASDAQE: MLTX) complied with federal securities laws. On September 28, 2025, MoonLake reported results from its VELA-1 and VELA-2 Phase 3 program, disclosing that in “VELA-2, intercurrent events in the higher-than-expected placebo arm precluded the study from achieving statistical significance in the week 16 primary endpoint using the composite strategy.” Follo ...

Group 1: Hong Kong Stocks - China Metallurgical Group (01618) rose nearly 7%, with institutions stating that the value of this resource-rich construction company needs urgent reassessment [1] - Rongchang Bio (09995) increased over 5%, as its innovative ophthalmic drug RC28 has been submitted for listing, following a partnership with Santen China [1] - Laikang Pharmaceutical-B (02105) surged nearly 6%, with a cumulative increase of 36% over the last three trading days, driven by positive preliminary results from the Phase I clinical MAD study of LAE102 [1] - UBTECH Robotics (09880) rose over 5%, with a report from CMB International recommending UBTECH as the top pick in the humanoid robot sector and raising its target price [1] - Innovent Biologics (09969) increased over 6%, as the company announced the first prescriptions for Tanshitumomab in several provinces [1] - BrainCo-B (06681) surged over 16%, benefiting from policy catalysts in the brain-computer interface industry, with its cognitive impairment digital therapy product having a first-mover advantage [1] - Yaoshi Bang (09885) rose over 10%, with high-margin business accelerating growth and POCT devices expected to see increased deployment in the second half of the year [1] - DCH Holdings (00179) fell over 7%, as Citigroup downgraded its investment rating from "Buy" to "Neutral," citing limited upside potential for the stock [1] - Minmetals Resources (01208) rose over 2%, planning to issue $500 million zero-coupon convertible bonds maturing in 2030 for overseas debt refinancing [1][2] Group 2: US Stocks - Alibaba (BABA.US) rose 4.65%, with Morgan Stanley reiterating an "Overweight" rating and raising the ADR target price from $165 to $200 [3] - Li Auto (LI.US) increased 3.57%, as the Li One officially commenced delivery at the Changzhou smart manufacturing base, with a report indicating that the i6 model's sales performance is expected to outperform the i8 [3] - JD.com (JD.US) rose 0.15%, announcing that the 2025 Double 11 shopping festival will start on October 9 at 8 PM, two days earlier than last year [3] - Xpeng Motors (XPEV.US) increased 1.76%, with the company announcing that the Xpeng MONA M03 has delivered a total of 180,000 units [3] - New Oriental (EDU.US) rose 4.38%, with a report indicating that the overall business development of the group is stabilizing [3] - Merus (MRUS.US) surged 35.97%, following an agreement with Danish biotech company Genmab for a cash acquisition at $97 per share [3] - Novo Nordisk (NVO.US) fell 0.20%, as Morgan Stanley downgraded its rating to "Sell" and reduced the target price from $99 to $47 [4] - MoonLake (MLTX.US) plummeted 89.93%, with trial results for its therapeutic drug falling far below expectations, leading to a significant target price cut by RBC [4] - TSMC (TSM.US) fell 0.05%, reaffirming that it has not engaged in discussions regarding potential investments or collaborations with any companies [4] - Micron Technology (MU.US) rose 4.22%, with Morgan Stanley predicting that the storage industry price increase cycle may continue into next year [4]

Stock Market Overview - U.S. stocks advanced, with the Nasdaq rising 107 points (0.48%) to 22,591.15, S&P 500 up 0.26% to 6,661.21, and Dow Jones increasing 0.15% to 46,316.07 [1] Wolfspeed Inc. (NYSE: WOLF) - Wolfspeed's stock surged by 1,726.45%, closing at $22.10, with an intraday high of $22.10 and a low of $8.05; it reached a 52-week high of $22.10 and a low of $0.39 [2] - The surge followed the announcement of a reorganization plan under Chapter 11 bankruptcy, which will reduce debt by 70% and cut interest payments by 60% [3] Tilray Brands, Inc. (NASDAQ: TLRY) - Tilray's shares increased by 60.87%, closing at $1.85, with a high of $1.86 and a low of $1.34; the stock's 52-week high and low are $1.86 and $0.35, respectively [4] Robinhood Markets Inc. (NASDAQ: HOOD) - Robinhood's stock rose 12.27%, closing at $136.72, with an intraday high of $136.84 and a low of $123.78; it achieved a new all-time high of $136.84, with a 52-week low of $22.05 [5][6] - The rally followed the CEO's announcement that event contracts on the platform topped four billion, with half traded in the third quarter alone, and a strong August report showing assets surged 112% year-over-year to $304 billion [6] Etsy - Etsy's shares climbed 15.83%, closing at $74.34, with a high of $75.77 and a low of $63.64; the stock's 52-week high and low are $75.77 and $40.05, respectively [6] - The increase was driven by OpenAI's unveiling of the "Buy it in ChatGPT" feature, allowing users to purchase directly from Etsy sellers [7] MoonLake Immunotherapeutics (NASDAQ: MLTX) - MoonLake's stock plummeted by 89.93%, closing at $6.24, with a high of $7.14 and a low of $5.95; the stock's 52-week high is $62.75, with a low of $5.95 [8] - The decline occurred despite positive results from MoonLake's Phase 3 VELA trial, which showed statistically significant HiSCR75 responses in patients with moderate to severe hidradenitis suppurativa [8]

Core Viewpoint - MoonLake Immunotherapeutics has experienced a significant shift in market perception following recent trial outcomes, leading to a downgrade by Jefferies from "Buy" to "Hold" [2][3]. Company Overview - MoonLake Immunotherapeutics specializes in innovative therapies for inflammatory diseases, particularly known for developing sonelokimab [1]. - The company competes in the immunotherapy space against other biotech firms [1]. Recent Developments - On September 29, 2025, Jefferies downgraded MoonLake's stock from "Buy" to "Hold," reflecting a more conservative outlook influenced by trial results [2]. - The downgrade coincided with the week-16 outcomes of the Phase 3 VELA-1 and VELA-2 trials, which evaluated sonelokimab's efficacy against the HiSCR75 endpoint [3]. Trial Details - The VELA trials enrolled 838 patients, comparing a 120mg dose of sonelokimab to a placebo, with all participants receiving the 120mg dose after week 16 until week 48 [4]. - The final evaluation of the trials was conducted at week 52 [4]. Market Reaction - Following the trial outcomes, MoonLake's stock experienced a significant downturn, plummeting approximately 89.93%, which translates to a $55.75 decrease [4]. - As of now, MLTX's stock is valued at $6.25, with fluctuations between a low of $5.96 and a high of $7.13 [5]. - Over the past year, the stock reached a peak of $62.75 and a low of $5.95, with a current market capitalization of approximately $396.57 million [5].

Core Viewpoint - MoonLake, a biotechnology company with a market value of nearly $4 billion, experienced a significant stock drop of 89% following disappointing Phase III clinical trial results for its experimental skin disease drug, sonelokimab [1][3]. Company Summary - MoonLake's sonelokimab showed a response rate 17 percentage points higher than the placebo group in the VELA-1 trial and a 9 percentage point difference in the VELA-2 trial, with treatment response rates of 35% and 36% compared to 18% and 26% for the placebo [4]. - Analysts expressed disappointment with the trial results, leading to significant downgrades in investment ratings and target prices from major banks, including Stifel and RBC [4][5]. - Following the trial data release, MoonLake's market capitalization dropped over $3.5 billion, from $3.98 billion to under $500 million [5]. Industry Context - The market for hidradenitis suppurativa (HS), the condition targeted by sonelokimab, is projected to grow from $2 billion to $15 billion by 2035 due to a large number of untreated patients [7]. - UCB SA, a competitor, saw its stock rise significantly after the trial results, with its drug Bimzelx showing a higher adjusted efficacy compared to sonelokimab [5][6]. - UCB's Bimzelx has been a key growth area, with 21% of its global net sales coming from HS treatment [6].

Core Viewpoint - MoonLake Immunotherapeutics is under investigation for potential violations of federal securities laws following disappointing results from its Phase 3 VELA trials for sonelokimab, leading to a significant drop in stock price [1][3]. Company Overview - MoonLake Immunotherapeutics is a clinical stage biotechnology company focused on therapies for inflammatory skin and joint diseases [2]. Trial Results - On September 29, 2025, MoonLake reported week 16 results from the VELA Phase 3 trials, which were highly anticipated but yielded disappointing outcomes, raising concerns about the drug's regulatory approval and commercial viability [3]. Stock Market Impact - Following the announcement of the trial results, MoonLake's stock price plummeted by $55.75 per share, nearly 90%, from $61.99 on September 28, 2025, to $6.24 on September 29, 2025 [3].

PresentationMatthias BodenstedtChief Financial Officer Welcome, everyone. Good morning, good afternoon. Thank you for joining today's webcast. My name is Matthias Bodenstedt, I'm the Chief Financial Officer of MoonLake Immunotherapeutics. As usual, I'm joined here by our Co-Founder and CSO, Kristian Reich; our Co-Founder and CEO, Jorge da Silva. We are also honored to be joined today by Professor Alexa Kimball, a leading [indiscernible] in HS. We will go through the data and then look forward to the thought ...

Company Performance - MoonLake Immunotherapeutics (NASDAQ:MLTX) experiences a drastic decrease in its stock price to $6.24, about 89.93% [1][6] - KALA BIO, Inc. (NASDAQ:KALA) sees its stock decline sharply to $2.13, translating to an 88.82% decrease [2][6] - IO Biotech, Inc. (NASDAQ:IOBT) experiences a 77.31% decrease in its stock price, falling to $0.35 [3][6] - Maris-Tech Ltd. (NASDAQ:MTEKW) sees its stock price decrease to $0.22, a 71.16% drop [4] Industry Insights - The recent market movements highlight the volatile nature of the stock market, where companies across various sectors can experience significant fluctuations [5] - Factors such as market sentiment, industry trends, and company-specific developments play crucial roles in influencing stock prices [5]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [1][2] - The news team operates from key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2] - Proactive focuses on medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [2][3] Group 2 - The team delivers news and insights across various sectors including biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] - Proactive adopts technology to enhance workflows and improve content production [4][5] - All content published by Proactive is edited and authored by humans, ensuring adherence to best practices in content production and search engine optimization [5]

Core Viewpoint - MoonLake Immunotherapeutics' stock price plummeted over 90% following the release of disappointing week-16 results from its Phase 3 VELA-1 and VELA-2 trials for sonelokimab, despite achieving statistical significance in primary and secondary endpoints [1][8]. Group 1: Trial Design and Results - A total of 838 patients were enrolled in the VELA trials, which compared a single 120mg dose of sonelokimab to placebo, with primary endpoint HiSCR75 assessed at week 16 [2]. - Both VELA-1 and VELA-2 trials achieved statistical significance for all key endpoints, including lesion counts and patient-reported outcomes, with p-values below 0.001 [3]. - Sonelokimab showed a statistically significant HiSCR75 response as early as week 4 in both studies [3]. Group 2: Efficacy and Patient Outcomes - At week 16, 34.8% of patients in VELA-1 and 35.9% in VELA-2 achieved HiSCR75, while placebo response rates were 17.5% and 25.6%, respectively [5]. - Approximately 30% of patients reported a significant reduction in pain, with at least a 3-point improvement in the worst pain NRS in both trials [6]. - Nearly 60% of patients experienced a meaningful improvement of 4 points or more in the Dermatology Quality of Life Index (DLQI), representing a 20 percentage-point benefit over baseline [7]. Group 3: Safety and Future Outlook - The safety profile of sonelokimab remained favorable, consistent with previous studies, and no new safety signals were reported [7]. - Preliminary analyses indicate that responses may continue to improve beyond week 16, with placebo patients achieving similar responses to those initially randomized to sonelokimab by week 20 [4].