Key Takeaways
- MoonLake shares jumped 18% today after AbbVie reported Phase 3 results for a rival hidradenitis suppurativa drug.
- AbbVie’s lutikizumab beat placebo by 8 percentage points on its main goal, a result RBC Capital called underwhelming.
- MoonLake’s sonelokimab beat placebo by about 14 points on the same measure a year ago, so AbbVie’s data makes it look stronger by comparison.
- The next test is whether the FDA accepts MoonLake’s application, which it submitted on Sept. 30.
MoonLake Immunotherapeutics (MLTX) shares are up 18% today, and the company hasn’t said a word. It didn’t need to – because AbbVie (ABBV) reported Phase 3 results for its own hidradenitis suppurativa (HS) drug this morning, and RBC Capital said the data “underwhelms.”
AbbVie cleared a low bar
AbbVie said lutikizumab met the main goal of its INTREPID trial. That goal was HiSCR75, meaning a patient’s abscesses and inflammatory nodules fall by at least 75% by week 16.
- 31.4% of patients on lutikizumab got there, vs. 23.4% on placebo
- Side effects ran level with placebo (53.4% vs. 53.7% had any adverse event)
That’s an 8-point gap on the main goal. RBC noted the trial hit its primary endpoint, and still called the data underwhelming.
Suddenly, MoonLake’s data looks pretty good
MoonLake ran the same test in its Phase 3 VELA program a year ago. Across both trials, 35.4% of patients on sonelokimab hit HiSCR75 at week 16, vs. 21.6% on placebo. That’s a gap of about 14 points.
Investors hammered the stock anyway, mostly because one of the two trials narrowly missed statistical significance on its main analysis after a high placebo response.
Now AbbVie has put up a smaller gap on the same measure. (Comparing separate trials is always rough, and the drugs work differently.) AbbVie’s clean safety data is a real edge, and it’ll lean on it.
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The FDA is the real test
MoonLake submitted sonelokimab to the FDA on Sept. 30, so it should learn around late November whether the agency has accepted the application. Under a standard review, the company has pointed to a potential US launch in the second half of 2027.
It has plenty of cash for the review, ending June with $537 million, up from $358 million in March…
(That said, drug launches are expensive, and I wouldn’t be surprised to see MoonLake raise more before sonelokimab reaches the market.)
Wall Street is already far more optimistic than the stock…
Even after today’s jump, shares trade at less than half the $29 consensus target, though targets run from $6 to $50.
My take: Today’s jump looks earned. AbbVie’s results make sonelokimab look like one of the stronger drugs in HS, and the stock was priced for a lot of doubt. Of course, a rival’s data can only carry MoonLake so far. The FDA’s call in the coming weeks matters far more.
So what is MoonLake stock actually worth?
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Disclaimer:
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