Takeda Q1 adjusted EPS beats estimates despite slight sales dip

Takeda (TYO:4502/NYSE:TAK) announced Japan's approval of ORZEYFUL (oveporexton) for treating narcolepsy type 1 (NT1) in adults. The drug, discovered by Takeda, is the first to target the underlying cause of NT1. Approval follows successful Phase 3 trials showing significant symptom improvements. ORZEYFUL is also approved in China and the U.S.

The FDA approved Orzeyful, a narcolepsy type 1 drug by Takeda, targeting the root cause by mimicking orexin. Clinical trials showed improved wakefulness, sleep, and fewer cataplexy episodes. Takeda's CEO called it a new chapter for treatment. The drug may also have applications for ADHD and Parkinson's. According to experts, more research is needed, as not all patients lack orexin.

Takeda Pharmaceutical (TSE:4502) received FDA approval for ORZEYFUL, a narcolepsy treatment. The stock rose 3.43% on the news, with a 31.54% total return over the past year. Analysts value the stock at ¥6,262.69, suggesting it is undervalued. Risks include generic competition and pipeline trial performance.

Takeda (TAK) reported Q1 2026 revenue of JPY 1.22 trillion, up 10.2% on an actual FX basis but down 0.5% at constant rates, citing Vyvanse generic erosion offset by core brands. Core operating profit was JPY 358.9 billion and core EPS JPY 154. FY2026 guidance: revenue JPY 4.64 trillion, core op profit JPY 1.16 trillion, adjusted FCF JPY 650-750B. Orzeyful China approved; U.S./Japan expected in Q2 2026.

Biotech roundup reports multiple FDA and EU approvals: Replimune’s TUDRIQEV with Bristol Myers Squibb’s nivolumab for advanced melanoma, Takeda’s ORZEYFUL for narcolepsy type 1, Moderna’s mFLUSIVA flu vaccine for adults 50+, Sanofi’s MenQuadfi expanded EU use, and Novartis’ Pluvicto combo for PSMA+ mHSPC. It also covers Lisata layoffs, Emergent restructuring and Q2 results, and deals including Tarsus-Alkeus and Evotec-Odyssey.

Takeda said the FDA approved Orzeyful (oveporexton), its first-in-class orexin receptor 2 agonist for narcolepsy type 1 in US adults. The company forecasts peak annual sales of $2bn to $3bn and plans a US launch in November, pending DEA scheduling. Approval follows two pivotal trials showing improved wakefulness and reduced cataplexy and other symptoms.