Concerns Over SK Biopharmaceuticals' Opakalim Clinical Hold Are Excessive; Target Price Set at 130,000 Won

[Financial News] iM Securities said market concerns over SK Biopharmaceuticals' partial clinical hold for Opakalim were excessive, maintaining its target price of 130,000 won and a 'Buy' rating. Based on the previous day's closing price of 79,100 won, the stock has 64.3% upside to the target price.
On the 15th, iM Securities analyst Jaewon Jeong said the U.S. Food and Drug Administration (FDA) had placed a partial clinical hold on Opakalim (BHV-7000) not because of insufficient efficacy or serious adverse effects in humans, but because of insufficient information on the human risks of a specific metabolite identified in rodents. He judged that the issue was not serious enough to undermine the company's fundamentals.
Opakalim is a novel epilepsy treatment candidate that SK Biopharmaceuticals recently licensed in for 1.1 trillion won.
Jeong analyzed that the FDA had decided to impose the partial clinical hold to conduct additional checks on whether the toxicity identified in rodents also occurs in humans.
He said the hold was likely to be lifted if SK Biopharmaceuticals clearly demonstrates differences in metabolic profiles between rodents and humans, in accordance with the MIST guidelines for assessing metabolite safety during new drug development.
Opakalim's RISE3 trial has completed patient enrollment, so the schedule for releasing top-line data in the second half of this year remains unchanged. Enrollment of new patients in RISE2 is temporarily suspended.
Jeong forecast, "The partner expects the FDA's clinical hold to be lifted as early as October or November, and the impact on the overall clinical timeline is unlikely to be significant."

[email protected] Kang Jung-mo Reporter