The company said it received positive regulatory feedback from the U.S. FDA following a Type B meeting regarding a drug used to treat hidradenitis suppurativa, a chronic inflammatory skin disorder.
- The FDA feedback indicates the company can establish substantial evidence of effectiveness without conducting additional hidradenitis suppurativa trials.
- The firm remains on track to submit its Biologic License Application for Sonelokimab in the second half of 2026.
- MoonLake will host an Investor Day on February 23 to review FDA feedback from the Type B meeting.
Shares of MoonLake Immunotherapeutics (MLTX) surged 45% in premarket trading on Thursday after the company said it received positive regulatory feedback from the U.S. Food and Drug Administration (FDA) following a Type B meeting regarding Sonelokimab (SLK), a drug used to treat hidradenitis suppurativa (HS), a chronic inflammatory skin disorder.
The FDA feedback indicates the company can establish substantial evidence of effectiveness (SEE) without conducting additional HS trials, using a Biologic License Application (BLA) supported by data from its existing VELA-1, VELA-2, and MIRA studies.
The agency advised including MIRA results to support efficacy and submitting VELA-2 data to inform the safety profile. Based on the official meeting outcome, the company remains on track to submit its BLA for Sonelokimab in the second half of 2026.
“The positive outcome of our Type B meeting with the FDA provides the clarity needed to support a pathway to approval for our existing HS program, with no additional clinical trials required. In addition, the fact that we can prepare the BLA with the wealth of data across the VELA and MIRA trials provides us and the FDA with flexibility to determine the best label possible, so that SLK, if approved, can have the most positive impact for HS patients,” said Jorge Santos da Silva, Founder and Chief Executive Officer at MoonLake Immunotherapeutics.
2026 Pipeline
MoonLake will host an Investor Day on Feb. 23, 2026, to review the FDA feedback from the Type B meeting and share new clinical data for SLK across indications, along with updates to its 2026 catalyst outlook.
The company also expects a steady flow of clinical readouts over the next year, including Phase 2 data in axial spondyloarthritis and multiple Phase 3 updates in psoriatic arthritis and HS. Key milestones include a Phase 2 axSpA readout in Q1 2026, several Phase 3 readouts by mid-2026, and a planned BLA submission in the second half of 2026.
How Did Stockwits Users React?
Retail sentiment on Stocktwits turned ‘extremely bullish’ from ‘bullish’ a day earlier, amid ‘high’ message volumes. MLTX was among the top trending stocks on the platform at the time of writing.
One user expects the stock to climb to $22 within a few sessions. It is currently trading at $16.2.
The stock has been under heavy selling pressure over the past year, declining nearly 80%.
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