Rolling sBLA initiated to the U.S. FDA for Leqembi® Iqlik™ (lecanemab-irmb) as a subcutaneous starting dose for the treatment of early Alzheimer's disease under Fast Track status
(NASDAQ:BIOA) STOCKHOLM, Sept. 2, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that they have initiated a rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Leqembi Iqlik...
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How likely is the FDA to grant approval for the subcutaneous Leqembi® Iqlik™ formulation and what is the expected timeline for a decision?
What impact will the Fast Track designation and potential approval have on BioArctic's (BIOA) revenue forecasts and share price in the short to medium term?
How does this subcutaneous formulation compare to competing early‑Alzheimer's therapies in terms of market share potential and pricing power?