Takeda Pharmaceutical is advancing its orexin receptor 2 (OX2R)-selective agonist toward regulatory submission after achieving two positive phase 3 trial outcomes. These results position the drug as a potential blockbuster therapy for narcolepsy, underscoring Takeda's commitment to expanding treatment options in sleep disorders. The successful phase 3 data mark a key milestone expected to catalyze an FDA filing within the current fiscal year, reflecting favorable clinical efficacy and safety data that support regulatory approval pathways.