MoonLake Seeks BLA for Sonelokimab; FDA Confirms Evidence of Effectiveness
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 09 2026
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Should l Buy MLTX?
Source: Newsfilter
- FDA Meeting Outcome: MoonLake's Type B meeting with the FDA confirmed that the BLA submission for Sonelokimab in HS can be based on existing data from the VELA-1, VELA-2, and MIRA trials, eliminating the need for additional clinical trials and accelerating the path to market.
- Clinical Trial Performance: In over 1,000 HS patients, the MIRA trial demonstrated a 43% response rate at week 12 with 120mg SLK, significantly outperforming placebo (p < 0.001), providing robust clinical support for the BLA submission.
- Market Opportunity: HS affects approximately 2% of the population, with a projected market opportunity of $15 billion by 2035, positioning MoonLake's SLK to meet this substantial unmet need while enhancing the company's competitiveness in the biopharmaceutical sector.
- Future Plans: MoonLake plans to submit the BLA in H2 2026 and will hold an Investor Day on February 23, 2026, to further discuss FDA feedback and new clinical data for SLK in HS and other indications, showcasing the company's confidence in future growth.
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Analyst Views on MLTX
Wall Street analysts forecast MLTX stock price to rise
12 Analyst Rating
9 Buy
2 Hold
1 Sell
Moderate Buy
Current: 15.610
Low
5.00
Averages
24.10
High
45.00
Current: 15.610
Low
5.00
Averages
24.10
High
45.00
About MLTX
MoonLake Immunotherapeutics, formerly known as Helix Acquisition Corp, is a Switzerland-based company engaged in the healthcare industry. The Firm is a clinical-stage biopharmaceutical company focused on the development of medicines for immunologic diseases, including inflammatory skin and joint diseases. The Company develops tri-specific nanobody Sonelokimab (SLK) which purpose is to target and penetrate difficult-to-reach inflamed tissues. SLK is a molecule with enhanced enrichment in deep skin & joints and binding of targets. SLK inhibits IL-17A and IL-17F inhibition to treat inflammatory diseases, by independently inhibiting the naturally-occurring IL-17 A/A, A/F and F/F dimers that drive inflammation in patients.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- International Trial Expansion: Dr. Porter-Brown plans to expand the Phase 2b trial footprint with international sites in the UK and Europe, which will not only aid in patient recruitment but also enhance Imagene's competitiveness in the global market.
- Innovative Treatment Potential: Imagene's IMG-007 is a monoclonal antibody targeting OX40 with unique product features, expected to provide new treatment options for patients with moderate-to-severe atopic dermatitis, filling a market gap and driving future growth for the company.
- Equity Incentive Plan: As an inducement for joining, Imagene will grant Dr. Porter-Brown 137,000 shares of common stock, reflecting the company's commitment to his leadership and aiming to attract top talent to drive the success of clinical projects.
See More
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Biotech Sector Growth: The biotech sector, particularly Moon Lake Immunotherapeutics, is gaining attention amid interest rate cuts and an AI boom, with significant stock price increases and a focus on clinical-stage biotech investments.
FDA Fast Track Designation: Moon Lake's lead drug, Sonelokimab, received Fast Track designation from the FDA for treating Palmoplantar Pustulosis, addressing a significant unmet medical need in the U.S. market.
Financial Stability: The company holds approximately $380.5 million in cash and equivalents, providing a strong financial foundation to support its regulatory filings and potential commercialization efforts without immediate capital raises.
Upcoming Investor Day: Moon Lake is set to host an Investor Day on February 23, 2026, focusing on data from its Phase 2 SOLARIS trial, which could further validate its drug's efficacy across various inflammatory diseases.
See More
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- Stock Volatility Risk: Analyst Cantor highlights that if the stock underperforms, it could decline by 85-90%, while Agarwal sees potential upside even if the HiSCR75 change is around 18%-19%, though the Phase 3 trial poses risks that may dampen investor confidence.
- Potential Upside Forecast: Should the HiSCR75 change fall between 20-25%, Avalo's stock could rally by 100-150%, and if it drops to 25-30%, the stock might skyrocket over 200%, indicating the market's sensitivity to efficacy outcomes.
- Analyst Rating Trends: Recently, Avalo Therapeutics has seen a positive trend in analyst ratings, with Guggenheim and HC Wainwright & Co. both issuing 'Buy' ratings, with Guggenheim setting a target price of $50.00, reflecting a bullish outlook for the company.
See More
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- Clinical Trial Support: This decision is based on results from the ongoing phase 2 LEDA trial, suggesting that sonelokimab shows promising efficacy in clinical trials, potentially offering new treatment options for patients.
- Accelerated Development: CEO Jorge Santos da Silva stated that this designation “can support the acceleration of our phase 3 program,” which will help shorten the time to market and enhance the company's competitiveness in the market.
- Positive Market Reaction: Following the FDA's Fast Track designation, MoonLake's stock has shown strong upward momentum, reflecting investor optimism regarding the drug's future success.
See More
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- Clinical Trial Plans: The company plans to submit a Biologics License Application (BLA) in H2 2026 and will discuss the latest developments in the PPP program at the upcoming Investor Day, showcasing its strategic positioning in dermatology.
- Market Opportunity: PPP is a severe chronic inflammatory disease with no approved treatments, and the FDA's Fast Track designation will help address this significant unmet medical need, indicating a substantial market potential.
- Future Milestones: MoonLake anticipates releasing multiple key clinical data points in 2026, including the Phase 3 trials for PPP and progress in other indications, further solidifying its leadership position in the biopharmaceutical sector.
See More
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- Hawkish Fed Comments Impact: Atlanta Fed President indicated the need for a restrictive monetary policy due to ongoing inflation pressures, causing the 10-year T-note yield to rise by 3 basis points to 4.16%, which exerted some pressure on the stock market.
- Mixed International Market Performance: The Euro Stoxx 50 closed up by 0.60%, while China's Shanghai Composite fell by 0.33%, reflecting a divergence in global market trends, prompting investors to focus on upcoming economic data.
See More
