Chemomab Therapeutics has announced that it has successfully completed its End-of-Phase 2 meeting with the FDA, aligning on the design of a single Phase 3 trial for its lead product candidate, ...
The Phase 1b trial consisted of 24 patients with Parkinson’s disease, who received twice-weekly dosing of either HER-096 or placebo over a four-week period. The trial’s exploratory biomarker program ...
CEO Paula Ragan highlighted 2024 as a transformative year for X4 Pharmaceuticals, with the U.S. approval and launch of XOLREMDI (mavorixafor) for WHIM syndrome, a rare immunodeficiency condition. The ...
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Acurx signals progress in Phase 3 ibezapolstat program with $12M credit line following regulatory alignment
David Luci, President and CEO, highlighted several significant developments, including the closing of a $2.5 million registered direct offering and the receipt of positive regulatory guidance from the ...
Ocugen announces FDA alignment for Phase 2/3 trial of gene therapy OCU410ST for Stargardt disease, showing promising initial results. Ocugen, Inc. announced it has received FDA approval to proceed ...
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BioAtla outlines $800M peak sales target for Oz-V as FDA alignment paves way for phase III launch
Jay Short, Co-Founder, CEO & Chairman, emphasized that BioAtla is "currently in advanced stages to finalize a strategic transaction with a potential partner by year-end." He announced FDA alignment on ...
– End-of-Phase 2 interactions with FDA complete; scientific advice received from EMA – – Company expects to dose first patient in global Phase 3 registrational trial, MAPKeeper 301, in mid-2026 – – ...
Discover IMRX’s innovative cancer drug atebimetinib and upcoming milestones. Learn about trial results, financial outlook, and catalysts. Click here to read.
Early-phase clinical trials, those first-in-human studies, are where years of research and millions in investment meet the ...
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