Shares of ABL Bio, a biopharmaceutical company focused on dual antibody research and development, have risen sharply following news that the U.S. Food and Drug Administration (FDA) has granted fast track designation to its cancer drug candidate.
As of 2:19 PM on June 17, ABL Bio's stock was trading at 109,500 won, up 10.94% or 10,800 won from the previous trading day. The stock even surged to 114,500 won earlier in the session.
The company announced that its dual antibody immuno-oncology drug, Zivastomig (ABL111), developed in collaboration with U.S. biotech firm Novabridge Biosciences, received fast track designation from the FDA. On June 9, ABL Bio also disclosed that it had added the FDA as a regulatory authority for its clinical trial plan amendment application.
With the FDA fast track designation, ABL Bio can engage closely with the FDA throughout the clinical development process, potentially expediting the review timeline. This news has been interpreted as a boost to investor sentiment.
Kim Jun-young, a researcher at Meritz Securities, noted in a company analysis report that "the key investment point is the clinical data momentum of Zivastomig," adding that the cancer drug has emerged as a core value driver for ABL Bio.
* This article has been translated by AI.
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