MoonLake Immunotherapeutics (MLTX) Price Target Raised to $45 At H.C. Wainwright on FDA Progress

We recently compiled a list of the 8 Best Immunology Stocks to Buy According to Hedge Funds . MoonLake Immunotherapeutics (NASDAQ:MLTX) is among the best immunology stocks.

TheFly reported on May 11 that H.C. Wainwright increased its price objective on MLTX to $45 from $40 while reaffirming a Buy rating on the stock. The revision followed encouraging regulatory progress for sonelokimab, the company’s nanobody-based therapy being developed for hidradenitis suppurativa. The firm highlighted the favorable outcome of MLTX’s final pre-application discussions with the FDA regarding the program, signaling continued advancement toward potential regulatory filings and supporting confidence in the treatment’s clinical development strategy.

On May 10, MoonLake Immunotherapeutics (NASDAQ:MLTX) provided a corporate and financial update highlighting regulatory progress for sonelokimab in hidradenitis suppurativa. Following a successful pre-BLA meeting with the FDA held on April 1, the company confirmed alignment on its planned biologics license application submission strategy, proposed labeling approach, and use of data from the MIRA and VELA-TEEN studies. MoonLake stated that the BLA filing for sonelokimab is scheduled for late September 2026, with potential FDA acceptance anticipated by the end of November 2026.

The company also noted continued advancement across additional clinical programs, including Phase 3 studies in psoriatic arthritis. Financially, MLTX ended the first quarter with $357.9 million in cash, cash equivalents, and short-term marketable securities, while maintaining expected funding capacity into the end of 2027 alongside access to up to $400 million through its Hercules Capital debt agreement.

MoonLake Immunotherapeutics (NASDAQ:MLTX) is a clinical-stage biopharmaceutical company developing treatments for inflammatory skin and joint diseases. Its lead therapy, sonelokimab, uses Nanobody technology to target IL-17A and IL-17F cytokines involved in immune-related conditions.

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