FDA Accepts Investigational New Drug Application for Laekna LAE118

Reuters01-14

FDA Accepts Investigational New Drug Application for Laekna LAE118

Laekna Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug $(IND)$ application for LAE118, a novel PI3Kα pan-mutant selective inhibitor intended for the treatment of patients with PIK3CA-mutant solid tumors. The company stated it will work closely with regulatory authorities to advance LAE118 into clinical studies. Laekna also cautioned that there is no guarantee the drug will ultimately be successfully developed and commercialized. No other beneficiary organizations were mentioned in the announcement.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Laekna Inc. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260114-11989850), on January 14, 2026, and is solely responsible for the information contained therein.

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Laekna also cautioned that there is no guarantee the drug will ultimately be successfully developed and commercialized. No other beneficiary organizations were mentioned in the announcement.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Laekna Inc. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. 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