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Investing.com - H.C. Wainwright has reiterated its Neutral rating on Shattuck Labs (NASDAQ:STTK) following the company’s announcement that the FDA has cleared its Investigational New Drug (IND) application for SL-325. The stock, which has declined over 70% in the past year, currently trades near $0.89. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 10.25, though it’s experiencing rapid cash burn.
The IND clearance allows Shattuck to proceed with a Phase 1 clinical study of SL-325, a potential first-in-class death-domain receptor 3 (DR3) antagonist antibody being developed for inflammatory bowel disease (IBD).
The randomized, double-blind, placebo-controlled Phase 1 study will evaluate safety, tolerability, immunogenicity, and pharmacokinetics in healthy volunteers, while determining the recommended Phase 2 dose and dosing schedule.
Shattuck expects to dose the first participant in the single-ascending dose portion of the trial in the third quarter of 2025, with the multiple-ascending dose portion commencing in the fourth quarter of 2025.
The company anticipates completing enrollment for the Phase 1 study by the second quarter of 2026, as it advances this potential treatment for IBD, which includes ulcerative colitis and Crohn’s disease.
In other recent news, Shattuck Labs announced a significant private placement financing expected to raise approximately $103 million. This funding round was led by OrbiMed and included participation from several investors, such as Coastlands Capital, Prosight Capital, Adage Capital, Redmile Group, and NextBio Capital. The proceeds will be used to advance the development of SL-325, a DR3 blocking antibody aimed at treating Crohn’s disease, ulcerative colitis, and other autoimmune conditions. Additionally, Leerink Partners adjusted its price target for Shattuck Labs, lowering it from $4.00 to $2.00 while maintaining an Outperform rating. This adjustment followed the company’s second-quarter 2025 earnings report and pipeline update, which revealed plans to start a Phase 1 trial for SL-325 in the current quarter. Furthermore, Shattuck Labs held its 2025 Annual Meeting of Stockholders, where all director nominees were elected, and the proposal to ratify the independent auditor was approved. These recent developments highlight key strategic and financial moves by the company.
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