<div id="readability-page-1"><div><ul> <li>In early January 2026, MoonLake Immunotherapeutics reported that the FDA had provided positive Type B meeting feedback, allowing a Biologics License Application for sonelokimab in hidradenitis suppurativa to proceed in the second half of 2026 using existing MIRA, VELA-1 and VELA-2 trial data without additional HS trials. </li> <li>An important nuance is that while the FDA accepted the overall evidence package and emphasized inclusion of VELA-2 for safety, it ruled out using mechanistic data plus a single trial as confirmatory evidence, shaping how MoonLake must frame efficacy in its filing. </li> <li>We’ll now look at how the FDA’s willingness to consider existing HS trial data without new studies influences MoonLake’s investment narrative. </li> </ul><p>Trump has pledged to &#34;unleash&#34; American oil and gas and these 22 US stocks have developments that are poised to benefit.</p><h2>What Is MoonLake Immunotherapeutics' Investment Narrative?</h2><p>To own MoonLake today, you have to believe that sonelokimab can convert its hidradenitis suppurativa data into an approved, commercially relevant product despite a mixed Phase 3 readout and a company with zero revenue and ongoing losses. The FDA’s Type B feedback is material because it effectively keeps the HS Biologics License Application on its original H2 2026 timetable using MIRA, VELA‑1 and VELA‑2, removing the overhang of an additional costly HS trial while clarifying that mechanistic evidence cannot substitute for a second definitive study. That shifts the near term focus back to regulatory review and readouts in axial spondyloarthritis and psoriatic arthritis, rather than rebuilding the HS program from scratch. The biggest risks now sit around regulatory interpretation of the VELA package, liquidity needs and ongoing shareholder litigation after the steep 2025 share price fall.</p><p> However, one key regulatory uncertainty around how the FDA weighs VELA‑2 still hangs over the stock.  Our valuation report unveils the possibility MoonLake Immunotherapeutics' shares may be trading at a premium.</p><h2>Exploring Other Perspectives</h2><figure><img height="476" src="https://imageproxy.pbkrs.com/https://images.simplywall.st/company/e9442131-6a6f-41dc-83c8-3f045a6f3c14/chart/earnings-and-revenue-growth?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" width="746" original-src="https://imageproxy.pbkrs.com/https://images.simplywall.st/company/e9442131-6a6f-41dc-83c8-3f045a6f3c14/chart/earnings-and-revenue-growth"/><figcaption>MLTX Earnings &amp; Revenue Growth as at Jan 2026</figcaption></figure><p> The single fair value estimate from the Simply Wall St Community sits at about US$18.63, reflecting just one private investor’s modeling. Set this against MoonLake’s reliance on an HS BLA built on existing trials, where any adverse FDA view on the VELA‑2 data could quickly reshape expectations and reminds you to weigh several different viewpoints before drawing your own conclusion.</p><p>Explore another fair value estimate on MoonLake Immunotherapeutics - why the stock might be worth as much as 11% more than the current price!</p><h2>Build Your Own MoonLake Immunotherapeutics Narrative</h2><p>Disagree with this assessment? Create your own narrative in under 3 minutes - extraordinary investment returns rarely come from following the herd.</p><ul><li>A great starting point for your MoonLake Immunotherapeutics research is our analysis highlighting 4 important warning signs that could impact your investment decision.</li><li>Our free MoonLake Immunotherapeutics research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate MoonLake Immunotherapeutics' overall financial health at a glance.</li></ul><h2>Seeking Other Investments?</h2><p>Don't miss your shot at the next 10-bagger. Our latest stock picks just dropped:</p><ul><li>Explore 23 top quantum computing companies leading the revolution in next-gen technology and shaping the future with breakthroughs in quantum algorithms, superconducting qubits, and cutting-edge research.</li><li>Uncover the next big thing with financially sound penny stocks that balance risk and reward.</li><li>These 13 companies survived and thrived after COVID and have the right ingredients to survive Trump's tariffs. Discover why before your portfolio feels the trade war pinch.</li></ul> <p><em> This article by Simply Wall St is general in nature. <strong>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.</strong> 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.</em></p></div></div>

<p>MoonLake Immunotherapeutics (MLTX) shares fell 7.4% following FDA approval for a Biologics License Application for sonelokimab in hidradenitis suppurativa, utilizing existing trial data. The FDA's feedback allows the application to proceed without new trials, but emphasizes the need for safety data from VELA-2. Investors must consider the mixed Phase 3 results and ongoing losses, while regulatory uncertainties remain. Valuation estimates suggest the stock could be trading at a premium, with potential for an 11% increase from current levels. The analysis highlights risks and encourages diverse perspectives on investment decisions.</p>

Simplywall

VG Health

iShares Biotechnology ETF

MoonLake Immunotherapeutics

VanEck Biotech ETF

Ark Genomic Revolution ETF

Invesco Biotechnology & Genome ETF

Invesco Nasdaq Biotechnology ETF

Health Care Select Sector SPDR

iShares US Pharma

Proshares Ultra Nasdaq Biotech

SPDR S&P Biotech

ALPS Medical Breakthrough

First Trust NYSE Arca Biotech Index Fd

MoonLake Immunotherapeutics (MLTX) Is Down 7.4% After FDA Clears HS BLA Path Using Existing Trials