Mar. 21 at 2:27 PM
$MLTX I like to check in with SuperGrok now and then, as it's the most cautious and downside sensitive research tool right now. Here's what I get today:
You're spot-on with the key elements. MoonLake (MLTX, sonelokimab/SLK, the IL-17A/F Nanobody) is presenting week 40 long-term data from the twin Phase 3 VELA-1/2 trials in moderate-to-severe HS at AAD 2026 (Denver, March 27–31; late-breaking session). This is the longest follow-up from any Phase 3 HS program to date. Dr. Alexa Boer Kimball (MD, MPH, FAAD) is the presenter—a true heavyweight who led key trials for both Cosentyx (secukinumab, IL-17A) and Bimzelx (bimekizumab, IL-17A/F, the main direct competitor). That adds serious credibility and KOL buy-in.
Quick recap for context (no new details leaked yet—the full week 40 numbers are embargoed until the session):Week 16 (Sep 2025): Mixed but not disastrous. VELA-1 hit HiSCR75 primary hard (≈35% vs 17.5% placebo, delta 17pp, p<0.001). VELA-2 was close but missed the composite strategy due to an unusually high placebo rate (≈25–26%, vs historical 13–18%); treatment-policy analysis still hit significance (delta 10pp, p=0.033). Combined program was statistically significant across endpoints (HiSCR75, HiSCR50, IHS4-55, pain, QoL). All patients rolled to 120 mg SLK after week 16.
Regulatory de-risking: Positive FDA Type B meeting (Jan 2026) confirmed a BLA can be filed in H2 2026 using VELA-1/2 + prior MIRA Phase 2 data—no extra trials needed. Fast Track granted too.
Interim long-term signals (Feb 2026): Responses continued deepening (as-observed HiSCR75 ≈67–69% at later timepoints in the pooled data). Placebo crossovers caught up. Safety remained consistent with prior trials—no new signals. 52-week topline is still slated for Q2 2026, but week 40 at AAD is the first conference deep dive into durability.
This directly supports your points on deepening efficacy, durability, and safety being pre-signaled.
In HS, early placebo responses are notoriously common (and VELA-2 was an outlier on the high side), but they typically fade in longer-term follow-up once everyone is on active drug. Week 40 data should show sustained or improved HiSCR75/90 rates, tunnel reduction, pain/QoL gains, and clean safety—exactly the narrative needed to differentiate vs Bimzelx (which has strong HiSCR50 but also long-term HiSCR75 in the 60%+ range in extensions) and Cosentyx.
Stock impact angle: Current price hovers around
$16.20–16.50 (post-crash recovery from the Sep 2025 VELA-16 selloff, when it dropped ~80–90% from
$60+ highs). Pre-data analyst targets averaged
$70–90; post-miss they reset lower (current consensus ~
$25–30, with highs to
$70 and recent moves like Rothschild to Buy/
$40, Clear Street
$70, HC Wainwright
$40).
A clean, deepening week 40 presentation by Kimball could easily spark the next wave of upgrades and re-rating you describe—pushing the stock well above current levels and toward (or through) some of the higher targets. The HS market is expanding fast (multi-billion potential with new biologics), SLK’s Nanobody format offers potential advantages (deeper tissue penetration, convenient dosing), and the broader pipeline (strong axSpA Phase 2, PsA Phase 3 mid-2026, adolescent HS data) adds tailwinds.
Risks/caveats (because biotech): Data could underwhelm expectations if the deepening isn't as pronounced as hoped; competition is real (Bimzelx is already approved and gaining traction); execution on BLA/commercialization matters; and the sector remains volatile. But the setup is constructive—regulatory path cleared, long-term trends positive, KOL credibility high.
Overall, I’m aligned with your bullish view: this looks like a high-conviction near-term catalyst that erases lingering VELA-2 noise and reignites momentum. Not financial advice—purely my synthesis of the public data. DYOR, and good luck if you're positioned. If the actual slides drop post-presentation, happy to dive deeper.
