Earnings, deals and disclosures from Japan's listed pharma & healthcare companies, in English.
Redasemtid, StemRIM's HMGB1-peptide drug licensed to Shionogi, missed its primary endpoint in a global stroke trial's no-reperfusion cohort, while a small four-patient trial in the rare skin disease dystrophic epidermolysis bullosa hit its mark with three ulcer closures; Shionogi now decides the stroke program's future.
China's NMPA cleared the self-injected, once-weekly formulation of Leqembi as first-line therapy, the second market after the US to allow at-home dosing for a disease that has mostly meant fortnightly hospital infusions.
Japan's health ministry listed Cuorips' heart-failure therapy ReHeart at ¥53.2mn per treatment for patients who have exhausted standard drug and invasive care, using the cost-calculation pricing method under the new-technology category.
FDA acceptance of a Phase 2 filing for an Alzheimer's cognition drug licensed from Nxera Pharma triggers a $10mn payment, about ¥1.59bn, that the company will book as third-quarter revenue under a fiscal year that already assumed it.
Oncolys BioPharma began commercial sales of its OBP-301 oncolytic virus therapy on August 21, about two and a half months after Japan's health ministry approved it for esophageal cancer patients who cannot have curative surgery or chemoradiotherapy, with Fujifilm Toyama Chemical distributing it to hospitals.
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.
Japan added Oncolys BioPharma's esophageal cancer cell therapy, development code OBP-301, to its national insurance price list at ¥3.1mn a unit, or ¥9.3mn per patient, with coverage starting August 13 and sales launching August 21 through Fujifilm Toyama Chemical.
The FDA cleared Takeda's oral drug oveporexton to restore the orexin signaling missing in narcolepsy type 1, not just mask its symptoms, but a scheduling review by the US Drug Enforcement Administration still stands between approval and the first sale.
Japan's health ministry has put the pricing of Oncolys BioPharma's newly approved esophageal cancer therapy on the agenda for the Chuikyo panel that deliberates national insurance drug prices, with the company still targeting a launch within the current fiscal year even as the earnings impact stays under review.
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.
FunPep's FPP004X hit its safety and antibody-response targets in a Phase 1 trial, with titers rising in 97 to 100 percent of subjects, but an exposure-chamber test found no symptom improvement over placebo, and the split result now goes to option-holder Shionogi for discussion on what comes next.
FDA feedback let AnGes skip a required pre-application meeting and start a staged BLA filing for its HGF gene therapy targeting severe leg ischemia in PAD patients, a procedural green light rather than any read on approval chances.
JCR Pharmaceuticals will file for Japanese approval of givinostat, already sold for Duchenne muscular dystrophy in the US, EU and UK, using foreign trial data instead of a fresh domestic pivotal study, with a 2027 launch in view after talks with Japan's drug regulator.
Eisai and Biogen can now sell a weekly, 15-second self-injection as the starting treatment for early Alzheimer's disease, not just the maintenance dose already approved last year.
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.