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AEON Biopharma submits IND to FDA for ABP-450 biosimilar pharmacodynamic study, advancing BOTOX biosimilar development.

Market News
09 Nov 2026, 15:00 WIB
GlobeNewsWire
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Bullish
AEON Biopharma submits IND to FDA for ABP-450 biosimilar pharmacodynamic study, advancing BOTOX biosimilar development.

AEON Biopharma has submitted an Investigational New Drug (IND) application to the FDA to start a comparative pharmacodynamic study of ABP-450, a biosimilar to BOTOX. This study will use compound muscle action potential (CMAP) measurements to objectively compare neuromuscular activity between ABP-450 and BOTOX, aiming to strengthen evidence for biosimilarity. The IND submission follows a recent FDA Type 2b meeting that clarified the development pathway, emphasizing sensitive scientific assessments over traditional clinical efficacy studies. The study is expected to begin in Q1 2027, moving AEON closer to potential full-label therapeutic approval and market entry in the U.S.

AEON Biopharma's recent IND submission for a pharmacodynamic study of ABP-450 is presented here with Pluang's health sector market context. For readers following the health sector, as of Nov 09, 2026 18:41 WIB, 108 of 150 priced US health stocks on Pluang rose while 26 fell. Notable movers include FLNA at USD 0.48 (+6.01%), LFST at USD 12.99 (-5.66%), and IONS at USD 37.25 (-5.50%).

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