[Click e-Stock] "SK Biopharmaceuticals: No Adverse Reactions in Over 1,200 Clinical Patients...Target Price Maintained at 160,000 Won"

Hana Securities: "New Drug Clinical Hold Issue Expected to Be Resolved Shortly"

On September 15, Hana Securities maintained its "Buy" investment rating and target price of 160,000 won for SK Biopharmaceuticals, a company specializing in epilepsy treatments. This is despite the recent partial clinical hold notification from the U.S. Food and Drug Administration (FDA) regarding Biohaven’s investigational drug candidate "Obkalam." The reason cited was that the FDA’s request was only for additional clarification on animal study findings, not due to any new adverse effects.

Lee Donghoon, President of SK Biopharmaceuticals, is making a presentation at a press briefing on the 26th of last month. SK Biopharmaceuticals

Previously, on the 10th, Biohaven was notified by the FDA to temporarily suspend new patient enrollment in the phase 3 RISE2 clinical trial for Obkalam. The agency requested further proof to determine whether a particular substance observed in non-clinical animal toxicity tests was a reaction unique to rodents such as mice.

Kim Seon-A, a researcher at Hana Securities, stated, "This measure was not implemented because any new toxicity or serious adverse reactions were observed in patients," and added, "Obkalam has been administered to over 1,200 patients with conditions such as depression, mania, and epilepsy, but no cases directly related to this finding have been confirmed."

SK Biopharmaceuticals has signed a licensing agreement to acquire the Obkalam technology, but as the U.S. antitrust (HSR Act) review is still ongoing, the contract has not been fully finalized and the upfront payment has not yet been made. Researcher Kim explained, "The company was already aware of and reviewed these findings during due diligence prior to signing the contract. Even though it is not expected to be a major issue, the parties are discussing finalizing the contract and making the upfront payment only after addressing the matters identified."

The impact on the clinical trial timeline is also expected to be limited. Of the two pivotal clinical trials for Obkalam, only RISE2—which was scheduled to announce results in early 2028—was affected by the FDA’s action; more than 600 patients already receiving the drug can continue their treatment. The RISE3 trial, for which patient enrollment concluded in June, will proceed with its results announcement timeline in the second half of the year unchanged. Biohaven plans to submit additional data by early next month and aims to resolve the issue between October and November.

Researcher Kim commented, "If the RISE3 results are positive, it should not be difficult to accelerate the RISE2 trial to make up for the delay. As there is still insufficient justification for delaying the projected 2029 launch of Obkalam, we are maintaining our target price," she said.

This content was produced with the assistance of AI translation services.