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Saturday, November 14, 2026Japan edition · 日本語
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Japan Pharma & Healthcare Company News (Page 3)

Earnings, deals and disclosures from Japan's listed pharma & healthcare companies, in English.

  1. FDA grants priority review to Takeda's psoriasis pill zasocitinib, decision due by March 2027

    The FDA has accepted Takeda's application for zasocitinib, a once-daily pill for moderate-to-severe plaque psoriasis, for priority review, with a decision due in the first quarter of 2027; across two phase 3 trials roughly 70% of patients reached clear or almost-clear skin by 16 weeks, well ahead of both placebo and the comparator drug apremilast, though Takeda says the filing itself does not change its earnings outlook for the year to March 2027.

  2. Otsuka's Taiho Unit Posts a Six-Month Survival Gain for a Rare Lung-Cancer Mutation

    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.

  3. FDA Blocks Seikagaku's US Bid for Back-Pain Drug Over Factory Deficiencies, Not the Data

    Seikagaku's Complete Response Letter from the FDA flags unresolved deficiencies at its active-ingredient plant and new problems at a contract formulator for SI-6603, with no concerns raised about the drug's efficacy or safety data and no resubmission date given.

  4. Tokyo Court Dismisses NTK's ¥203bn Damages Claim Against Daiichi Sankyo

    A Tokyo court dismissed every claim in Northern TK Venture's three-year suit against Daiichi Sankyo, including a demand that swelled from ¥20bn to ¥203.3bn over a blocked Fortis Healthcare tender offer, though an appeal remains possible.

  5. StemRIM's Shionogi-Partnered Stroke Drug Misses Its Primary Endpoint While a Rare-Disease Trial Delivers

    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.

  6. Evo Fund Cuts Delta-Fly Pharma Stake to 33.39% After Cashing In Cut-Price Warrants

    The Cayman fund acquired warrants priced at ¥0.14 apiece that the filing logs under a 41.14% holding-ratio entry, then exercised and sold into the market through August, trimming its combined stake to 33.39% from 41.97% by September 1.

  7. China Approves Home-Injectable Version of Eisai's Alzheimer's Drug Leqembi

    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.

  8. Cuorips' ReHeart Wins Japan Insurance Listing at ¥53.2mn Per Treatment

    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.

  9. Nxera Pharma to Book $10mn Milestone After Neurocrine Clears FDA Hurdle on Alzheimer's Drug

    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.

  10. Oncolys Starts Selling Esophageal Cancer Virus Therapy in Japan

    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.

  11. A ¥6.6bn Reversal, Not Sales Growth, Pushed GNI Group Into the Black

    A ¥6.6bn reversal of Cullgen's preferred-share interest, not stronger drug sales, pushed GNI Group into the black for the first half, and the real growth test starts next quarter when Ayumi Pharmaceutical's revenue is added to the books.

  12. SymBio's ¥6.77bn EVO Fund Deal Could More Than Double Its Share Count

    SymBio Pharmaceuticals lined up an estimated ¥6.77bn from Cayman fund EVO Fund to keep its antiviral drug trials funded through March 2028, but the bond-and-warrant structure could swell its share count by more than 125% if every warrant is exercised.

  13. Taiho's Zipalertinib Clears Key Lung Cancer Trial Hurdle, Setting Up FDA Push

    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.

  14. Japan Prices Oncolys BioPharma's Esophageal Cancer Therapy at ¥9.3mn a Patient

    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.

  15. Sumitomo Pharma Disputes Short-Seller's Image-Duplication Claims on Kyoto-Linked Drug

    Gotham City Research, which admits it is short Sumitomo Pharma's stock, has accused the drugmaker of hiding image-duplication problems in research behind a treatment developed with Kyoto University; the company calls the report one-sided and defends its approval data.

  16. Sumitomo Pharma Rebuts Short-Seller Over ¥164.5bn Swiss Dividend and Receivables Jump

    Sumitomo Pharma says a ¥164.5bn dividend from its Swiss unit and a jump in receivables were routine accounting, not the earnings-management scheme Gotham City Research alleged in an August 3 short-seller report.

  17. Takeda's ORZEYFUL Wins FDA Approval as First Drug to Treat Narcolepsy Type 1's Root Cause

    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.

  18. Astellas's Cancer Drugs and a Weak Yen Combine to Nearly Double Quarterly Profit

    A weaker yen added ¥60bn to Astellas Pharma's quarterly revenue and helped core operating profit jump 55.6% to ¥221.4bn, but strong sales of PADCEV and newer cancer drugs did the rest of the work, and the company is still not raising its full-year forecast.

  19. Oncolys's Esophageal Cancer Virus Therapy Reaches Japan's Drug Pricing Panel

    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.

  20. Otsuka's Kidney Drug Keeps Function Loss Near Normal Aging Rate for Two Full Years

    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.

  21. Eisai's Alzheimer's Drug Leqembi Grows 27% as Quarterly Profit Jumps 26%

    Lenvima, Leqembi and Dayvigo again did the heavy lifting for Eisai's first quarter, with Leqembi's Americas sales up 71% masking a China pullback tied to last year's distributor stocking, while the drugmaker left its full-year targets exactly where it set them in May.

  22. Shionogi Books 90% of Its First-Half Profit Target in One Quarter

    A string of drugmaker acquisitions, not stronger underlying sales, pushed Shionogi's quarterly net profit up 148% to ¥97.7bn, covering most of its own first-half profit guidance within three months while cutting its cash pile by more than half.

  23. Daiichi Sankyo Lifts Sales Outlook on Cancer Drugs, Trims Profit Forecast on Tax Bill

    Enhertu and Datroway drove a 21.1% revenue jump for Daiichi Sankyo and prompted an upgraded sales and operating-profit outlook, yet a jump in the effective tax rate to 24.9% means the company actually cut its full-year net profit guidance by ¥9bn.

  24. Takeda's Yen Boost Masks a Flat Underlying Quarter

    A weaker yen pushed Takeda's quarterly revenue up 10.2%, but at constant currency sales actually fell 0.5% and net profit dropped 23.5%, more than double the decline shown in headline yen figures, even as full-year targets and the dividend forecast held steady.

Japan Pharma & Healthcare Company News (Page 3) | Tokyo Brief