By skyforbes Thesis (TL;DR): MoonLake fell off a cliff after its big HS Phase 3 readout—down nearly 90%—because the market hyper-focused on a single narrowly missed endpoint, not the whole data set. Under the surface, sonelokimab (SLK) hit consistent, significant efficacy and is being evaluated for multiple diseases, with two pivotal catalysts coming within weeks. This is one of those rare moments where “disaster” headlines might be the exact signal for opportunity.
Data & Why the Panic Is Overdone:
• VELA-1: Big win. Mid-30s HiSCR response vs teens placebo, all core secondaries positive.
• VELA-2: Drug effect consistent with VELA-1, but placebo rate jumped—primary missed by a thread (p ≈ .05). All secondary endpoints still positive; combined analysis is strongly significant (p < 0.001).
• Takeaway: High placebo noise like this is standard in HS trials. Look at the totality: consistent drug effect, positive secondaries, and durable benefit, not “dead drug.”
More Than HS: Platform Upside (4 Indications):SLK is not a one-trick pony. MoonLake is moving fast across multiple indications, including:
• Hidradenitis Suppurativa (HS): Adult and adolescent, with long-term extension data.
• Palmoplantar Pustulosis (PPP): LEDA Phase 2 expected very soon—if positive, immediate pipeline upgrade.
• Axial Spondyloarthritis (axSpA): S-OLARIS readout Q1 2026.
• Psoriatic Arthritis (PsA): IZAR Phase 3, 2026.
Upcoming Catalysts (Why Act Now):
• Dec 15, 2025: FDA Type B meeting to discuss whether the current HS data package is sufficient to support a Biologics License Application. A “yes” could drive a meaningful stock rerating higher, while a “not without additional data” outcome appears largely already reflected in the prior 90% one‑day decline but would buy additional time setting MLTX up for potential rerating as we get additional data readouts on the various trials and indications within the next year.
• Q4 2025: LEDA PPP readout—further potential to validate the SLK platform, not just HS.
• Q1–Q2 2026: S-OLARIS (axSpA), VELA-TEEN/long-term HS, IZAR (PsA).
You basically have a week or two to get a thesis-confirming or thesis-breaking regulatory answer—at panic-level valuations.
Balance Sheet: MoonLake isn’t hurting for cash. They have hundreds of millions on hand, a fresh $75M raise, with extended runway into 2027. You’re not waiting for a raise headline after every catalyst; you’re waiting for data, and more data is coming imminently.
Lawsuit/FUD Section (for the Record):Yes, the numerous class actions headlines exist: they claim management pumped SLK effectiveness beyond what the data readouts allegedly showed, if you only focus one a single narrowly missed data point ultimately caused by higher placebo response. In biotech, legal and headline risk is always present post-drop, but those lawsuits don’t change the underlying drug effect or what the FDA—and larger future pharma buyers—will review soon. The lawsuits are noise; the SLK’s efficacy and a path forward to FDA approval is the signal.
Risks:
• FDA could require more data or reject the BLA proposal—delays and more cash burn.
• LEDA readout/other pipeline indications could go nowhere and this is still a one-asset, high-volatility biotech—but I like the data so far.
Asymmetric Setup: Almost all the bad is priced in after the crash—what’s not priced in is a credible FDA greenlight, positive PPP data, and the multi-indication platform angle. The next two catalysts (FDA and LEDA) will likely decide if this rerates violently higher, in the very near term.
This window, with two catalysts stacked right in front of the tape and the whole Street trading off panic and lawsuits, could close fast. Part of the reason I'm so bullish here is MLTX is a small overlooked stock, which has pretty much been left for dead here after the Phase 3 VELA Primary Endpoint headline "miss". The data is there – SLK works, the market has priced MLTX like SLK doesn't work. But the data says it does, and there are additional trials to show that SLK works across not just HS, but also PPP, PsA, axSpA but the market is still pricing MLTX like SLK doesn't work. I believe that means the market needs to reprice higher, and rapidly with the barrage of catalysts ahead on this one.
I have other holdings than this but just to satisfy requirements—I'm posting this one.
Disclosure: I (obviously) own MLTX stock and MLTX stock options, my kids even own MLTX. I like the stock. I don't know your personal financial situation, this is not financial advice. Do your own research.