FDA Submission
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Hemostemix Submits FDA Filing 1517 for ACP-01 (VesCell™) Basket Protocol Targeting Multiple Ischemic and Vascular Indications
Hemostemix (HMTXF) filed an FDA Pre-IND application for a Phase I basket trial of ACP-01 (VesCell™) to evaluate its safety and early efficacy across vascular dementia, peripheral arterial disease, angina, cardiomyopathy, and congestive heart failure. Hemostemix aims to use real-world evidence from Florida, where ACP-01 is available, to support regulatory advancement. The company has completed 498 safe treatments and has 11 peer-reviewed publications. The basket protocol seeks to accelerate development and expand target markets.
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VYVGART Demonstrates Positive Topline Results in AChR-Ab Seronegative gMG (ADAPT SERON Study)
Argenx’s VYVGART® demonstrated statistically significant improvements in AChR-Ab seronegative generalized myasthenia gravis (gMG) patients in the ADAPT SERON phase 3 study (p=0.0068). This is the first global Phase 3 study showing benefits across MuSK+, LRP4+, and triple seronegative subtypes. Argenx plans to submit an sBLA to the FDA by the end of 2025 to expand VYVGART’s label. The drug maintained its consistent safety profile. The results position VYVGART as a potential foundational therapy for a broader gMG population.
