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BioTech Breakout: MoonLake Up 30% On FDA Wins
Written by Jeffrey Neal Johnson. Publication Date: 2/3/2026.
Article Highlights
- The FDA recently granted Fast Track designation to MoonLake Immunotherapeutics' lead drug for a severe skin condition while clearing the path for a major filing.
- Management maintains a robust balance sheet that provides a cash runway extending well into the future to support ongoing clinical development plans.
- Rising share prices and upcoming data readouts could pressure short sellers who bet against the stock now that the period of uncertainty has passed.
In a stock market currently obsessed with interest rate cuts and the artificial intelligence (AI) boom, it is easy to overlook the biotechnology sector. But for investors willing to look beyond the Magnificent Seven, clinical-stage biotech remains one of the few places to find event-driven returns that are largely independent of the broader economy.
MoonLake Immunotherapeutics (NASDAQ: MLTX) is illustrating that point in real time. The stock rose roughly 10% in the first trading days of February 2026, pushing its price above $16. That move is part of a broader recovery, with shares up more than 30% over the last month. While volatility is the price of admission in this sector, MoonLake's recent rally is backed by a string of concrete regulatory wins that materially change the company's outlook.
Clearing a Path: The Month of Regulatory Wins
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Almost no one sees it coming, but AI is about to split America into two over the next 12 months. On one hand, it'll make America's one-percenters richer and more powerful than ever. On the other hand, it's set to trap millions of hardworking Americans in financial quicksand. Former Google exec Kai-Fu Lee says AI could wipe out 50% of jobs by 2027. Elon Musk has said AI will surpass human intelligence by 2027. Mark Zuckerberg has said half of all coding could be done by AI within the next year. One ex-hedge fund manager whose team predicted Nvidia's rise in 2020 calls this the AI End Game, and he says there are three critical moves every American should make in the next 12 months to protect and grow their wealth through this paradigm shift.
See the three moves before the AI split happensThe spark for the rally came on Feb. 2, 2026, when the U.S. Food and Drug Administration (FDA) granted Fast Track designation to MoonLake's lead drug, sonelokimab, for the treatment of palmoplantar pustulosis (PPP).
PPP is a severe, chronic skin condition that causes painful blisters on the palms and soles. There are no approved treatments for PPP in the United States, which represents a meaningful unmet need.
Fast Track is more than a buzzword. It is a formal FDA designation for drugs that show potential to address serious conditions and it carries tangible advantages for the development timeline and regulatory process.
Its two main benefits are:
- Access: More frequent interactions with the FDA, helping the company avoid costly missteps in development.
- Speed: Rolling review, which lets MoonLake submit completed sections of its application as they become ready instead of waiting to file everything at once — potentially shaving months off the approval timeline.
That news followed an even bigger victory. On Jan. 8, 2026, the company announced the outcome of a Type B meeting with the FDA about its primary target, hidradenitis suppurativa (HS). After mixed HS trial results in 2025 had pressured MoonLake's stock, investors feared the agency would require a new, costly multi-year study.
Instead, the FDA indicated the existing data are sufficient to support a regulatory filing — a major de-risking event. By clearing the regulatory path for HS and granting Fast Track for PPP, the agency has effectively validated MoonLake's Nanobody platform. These molecules are smaller than traditional antibodies and can better penetrate inflamed tissue. Positive regulatory outcomes across multiple indications suggest the platform is working and shift MoonLake from a speculative play to a company with a viable, diversified pipeline.
Cash Is King: Funded Through 2027
Many small biotech companies follow stock rallies with secondary offerings that dilute existing shareholders. MoonLake, however, is in a stronger position. According to its third-quarter 2025 financial report, the company had about $380.5 million in cash, cash equivalents, and short-term securities.
In drug development, cash equals time. Based on current burn rates, MoonLake's runway extends into the second half of 2027. That financial stability allows management to prioritize execution and regulatory filings rather than immediate fundraising, lowering the short-term risk of a dilutive capital raise.
Skeptics vs. Momentum: The Setup for a Rally
Despite the regulatory progress and a healthy balance sheet, skepticism remains. As of mid-January 2026, short interest in MoonLake was about 12.7% of the float.
Short sellers likely accumulated positions during the company's 2025 downturn, betting on operational problems or dilution. The recent FDA updates, however, undermine that bearish thesis. If positive news continues and the stock rises, short sellers will face mounting losses and may be forced to cover by buying shares — a dynamic that can accelerate a rally. With roughly 12.7% of the float sold short, there is significant potential buying pressure on the sidelines that could amplify momentum.
Investor Day Preview: The Next Big Mover
The recent surge may be only the opening act. MoonLake will host an Investor Day on Feb. 23, 2026, where the spotlight will be on data from the Phase 2 S-OLARIS trial testing sonelokimab in axial spondyloarthritis (axSpA), a form of spine-involving arthritis. A positive readout would add a third indication for the drug and further validate its broad anti-inflammatory potential.
Later in 2026, investors should watch for 52-week data from the HS trials, expected in the second quarter, followed by a potential Biologics License Application (BLA) submission in the second half of the year — a clear near-term regulatory catalyst.
Risk, Reward, and Regulatory Alpha
MoonLake Immunotherapeutics has navigated a critical stretch that sinks many early-stage biotechs. Securing a clear pathway to approval for HS and Fast Track status for PPP meaningfully de-risks the company. While commercial execution, pricing, and competition remain uncertainties, the combination of regulatory clarity, a solid balance sheet, and a market positioned for a short squeeze makes MoonLake a compelling story to watch in 2026. For investors seeking idiosyncratic growth, MoonLake is worth following closely.
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