Latest Tokyo Brief coverage on Otsuka Holdings Co., Ltd., tracking filings, financial news, and market signals from Japan.
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Otsuka says Taiho has begun an FDA application for zipalertinib with chemotherapy in untreated EGFR exon 20 lung cancer, with the filing due to finish by end-2026 and no change to the company's current-year forecast.
Zipalertinib plus chemotherapy nearly doubled progression-free survival to 14.5 months against a hard-to-treat EGFR mutation in a Phase 3 readout, but the drug is approved nowhere and Otsuka is leaving its current profit forecast untouched.
An independent panel has unblinded a 285-patient global trial after Otsuka subsidiary Taiho's lung cancer drug beat chemotherapy alone on progression-free survival, opening the door to a first-line approval bid for a mutation with few existing treatments.
Two-year Phase 3 data show sibeprenlimab slows IgA nephropathy patients' kidney decline to roughly the rate seen in healthy aging, a result Otsuka Holdings is using to push VOYXACT toward full US approval.
A slower-than-expected arrival of generic rivals for two of its drugs, plus a weaker yen, is pushing Otsuka Holdings' first-half net profit to ¥215bn, 68% above the guidance it issued in February.
Positive phase 3 data move the IgA nephropathy treatment beyond its earlier proteinuria-based accelerated approval, while leaving Otsuka's outlook for the year ending December 2026 unchanged.