Guggenheim Reiterates Buy Rating on Moonlake Immunotherapeutics (MLTX), Top Pick

Guggenheim analyst Yatin Suneja reiterated a Buy rating and $80.00 price target on Moonlake Immunotherapeutics (NASDAQ: MLTX).

The analyst comments "Key Message: This morning, INCY announced topline results (HERE) from the Phase III STOP-HS 1&2 trials evaluating safety & efficacy of povorcitinib (oral JAK1 inhibitor) in moderate-to-severe adult patients with hidradenitis suppurativa (HS). The study met the primary endpoints (HiSCR-50 at week 12) at both doses tested (10.6% & 10.9% pbo-adj. HiSCR-50 in STOP-HS1 and 13.8% & 13.8% pbo-adj. HiSCR-50 at 45 & 75 mg, respectively). In bio-experienced subgroup, povorcitinib showed higher differential efficacy (19.1% & 18.3% pbo-adj. pooled HiSCR-50 at 45 & 75 mg, respectively). With regard to more stringent HiSCR-75 endpoint, povorcitinib achieved pbo-adj. score of only 4.8% & 8.5% in STOP-HS1 (not stat-sig), and 12.3% & 15.1% in STOP-HS2 studies. On the safety side, no new adverse effects were observed, and both doses were well-tolerated. We don't believe this is a competitive profile (see comp table below), and we believe IL-17 A/F targeting drugs will likely emerge as the preferred standard of care for HS (Recall that MLTX's sonelokimab, an IL-17A/F dual-targeting nanobody, achieved 29% pbo-adj. HiSCR-75 and 38% pbo-adj. HiSCR-50 in Phase IIb MIRA study; See HERE; UCB's Bimzelx has produced ~15-20% HiSCR-75 pbo-delta in two Phase IIIs.) We want to reiterate that the efficacy benchmark at ~Δ20% pbo-adj. HiSCR75 should enable SLK to emerge as the gold standard drug in HS (See our recent breakfast highlight HERE). We also note that placebo response of 29%/13-16% for HiSCR-50/75 in povo's studies are in-line with what MLTX mgmt has commented in the past. The next key potential catalyst for MLTX is the pivotal Phase III VELA study topline readout in mid-2025 (we think in July/August timeframe), and the company will host in-person & virtual Capital Markets Update in 2Q25 to provide update on Phase III VELA program, discussing additional clinical data and financial updates. MLTX remains our Best Idea."

For an analyst ratings summary and ratings history on Moonlake Immunotherapeutics click here. For more ratings news on Moonlake Immunotherapeutics click here.

Shares of Moonlake Immunotherapeutics closed at $38.55 yesterday.

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