BTIG has reaffirmed its Buy rating and kept a $24.00 price target on Moonlake Immunotherapeutics (NASDAQ: MLTX) as investors await pivotal Phase 2 clinical data for sonelokimab (SLK), the company’s albumin-binding anti-IL-17A/F Nanobody. The research firm’s note arrives while the stock is trading at $15.38, which equates to roughly a 56% potential upside to BTIG’s target.
According to InvestingPro data, analyst price targets on MLTX span a wide range from $6 to $34. BTIG expects Moonlake to present the Phase 2 axSpA - axial spondylarthritis - dataset for SLK at the company’s Investor Day on February 23. That presentation is scheduled just days ahead of Moonlake’s quarterly earnings report on February 26.
BTIG’s assessment of the upcoming data
BTIG frames the Phase 2 axSpA readout as a favorable risk/reward opportunity, noting the indication has historically received limited credit from investors despite an asserted substantial unmet need and large market potential. Moonlake estimates the axSpA market could reach $10 billion to $15 billion by the mid-2030s, a figure BTIG cites in evaluating upside potential tied to positive data.
From a balance sheet perspective, InvestingPro analysis shows Moonlake carries more cash than debt and reports a current ratio of 8.5, which BTIG interprets as providing sufficient runway to support ongoing development programs through near-term milestones.
BTIG also highlights the construct of SLK - a small albumin-binding Nanobody - as a potential differentiator versus traditional monoclonal antibodies used in rheumatology. The firm notes preclinical evidence that SLK may preferentially localize in target tissues and that the smaller albumin-binding design could confer a higher therapeutic index compared with prior monoclonal approaches.
Regulatory and commercial timeline
BTIG expects investor attention to concentrate on Moonlake’s rheumatology catalysts through the rest of 2026, with a separate regulatory pathway in hidradenitis suppurativa (HS) also in view. Moonlake plans a Biologics License Application filing for HS in the second half of 2026, with a likely PDUFA date projected in the second half of 2027.
Recent regulatory developments include the FDA granting Fast Track designation to SLK for moderate-to-severe palmoplantar pustulosis (PPP), a decision supported by positive Phase 2 LEDA trial results. BTIG cited positive regulatory feedback from the FDA on SLK in HS when it upgraded Moonlake from Neutral to Buy and established the $24.00 price target.
Divergent analyst views
Analyst coverage of Moonlake is mixed. Goldman Sachs downgraded the stock from Neutral to Sell while moving its price target to $10.00, citing concerns about the approval process for HS. In contrast, H.C. Wainwright reiterated a Buy rating and assigned a $32.00 price target after the FDA’s Fast Track designation.
Market performance and investor positioning
MLTX has experienced significant volatility. The shares have fallen 70.4% over the past six months but have posted a 17.7% gain year-to-date, reflecting a market that has reduced the company’s valuation over a longer horizon while potentially pricing in nearer-term catalysts.
BTIG’s view, as reflected in its reiteration and upgrade history, is that the Phase 2 axSpA dataset and regulatory momentum in other indications create a favorable asymmetric opportunity for investors willing to take early-stage clinical risk.
Summary
BTIG reiterated a Buy rating and a $24.00 price target on Moonlake Immunotherapeutics as the company prepares to unveil Phase 2 axSpA data for sonelokimab at Investor Day on February 23, ahead of earnings on February 26. The shares trade at $15.38, implying around 56% upside to the BTIG target, while analyst price targets range from $6 to $34 per InvestingPro data. Regulatory progress includes FDA Fast Track status in PPP and favorable feedback on the HS development plan, with the HS BLA filing expected in H2 2026 and a likely PDUFA in H2 2027.
Key points
- BTIG maintains Buy on MLTX with a $24.00 target; current price $15.38 implies ~56% upside.
- Phase 2 axSpA data for SLK will be presented on February 23; earnings follow on February 26, making the next week a concentrated catalyst period.
- Regulatory progress includes FDA Fast Track designation for SLK in PPP; HS BLA filing targeted for H2 2026 with a likely PDUFA in H2 2027.
Risks and uncertainties
- Clinical risk - the Phase 2 axSpA readout could underdeliver versus expectations, affecting development timelines and valuation; this directly impacts biopharma and healthcare sectors.
- Regulatory risk - uncertainty around approval pathways for HS was cited by Goldman Sachs as a reason for a downgrade, highlighting the possibility of regulatory delays or requirements that could alter commercial timing.
- Market risk - the stock has shown substantial downside over six months (-70.4%), indicating potential for continued volatility in response to trial or regulatory news; this influences investor appetite in small-cap biotech equities.
Overall, Moonlake sits at a juncture where clinical readouts and regulatory feedback will be primary drivers of near-term value, while cash runway metrics and analyst divergence underline both opportunity and risk for the biotech and broader healthcare investing community.