Earnings, deals and disclosures from Japan's listed pharma & healthcare companies, in English.
Ono Pharmaceutical will pay Biohaven $80mn upfront, $20mn in development milestones and a royalty of about 20% of sales for Asian rights to three IgG-degrading drugs, led by BHV-1300, now in phase 3 for Graves' disease.
Japan's health ministry has said Stella Pharma's application to extend Steboronine to recurrent meningioma will go before a pharmaceutical affairs council committee, a review step rather than an approval, on a label wider than the high-grade patients in its trial.
Otsuka's US arm completed its rolling submission on October 6 seeking traditional FDA approval for VOYXACT in adult IgA nephropathy, a drug already approved on an accelerated basis; the company kept its 2026 forecast unchanged.
GNI Group says it will be added to TOPIX from October 30, selected from the Tokyo Stock Exchange's Growth market in the first regular reshuffle since the index opened selection to all three market segments.
Carna Biosciences will supply monzosertib and bear study costs in a Phase 1b trial at MD Anderson for relapsed or refractory AML, now under a signed contract; the notice reports no patient entry or results, and Carna will not routinely announce registry updates.
J-Pharma's Phase 3 biliary cancer trial was selected for AMED support covering half of eligible costs, up to ¥1.5bn, and the company says full payment would fund Part A without new financing.
Shionogi will buy all of US rare-disease drugmaker IntraBio for $2bn, taking worldwide rights to AQNEURSA, which won a first-of-its-kind ataxia-telangiectasia approval on 18 September; closing is targeted for November or December, subject to clearances.
Rohto Pharmaceutical lifted its 2030 sales target to ¥444.0bn from ¥415.0bn while lowering the margin goal to 12.8% from 13%, and set 2031 targets including a 40% dividend payout ratio.
JCR Pharmaceuticals will keep manufacturing JR-141 while Italfarmaco takes over sales in the US, Europe and Latin America after approvals, with the upfront payment already in JCR's current-year forecast.
A fund run by JIC Venture Growth Investments bought 619,700 Cuorips shares at ¥4,841 each in a third-party allotment, paid from its own fund money, and says it is a pure investment with no significant proposals.
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.
Northern TK Venture has appealed to the Tokyo High Court after the district court threw out its entire ¥203.3 billion damages claim against Daiichi Sankyo over a blocked Fortis Healthcare tender offer, and the pharma company now says the earnings impact is under review rather than nil.
An interim analysis of Chugai's Phase 2 obesity trial for the myostatin antibody emugrobart found the targeted weight loss unlikely, so Roche is exiting the program entirely and is set to return all license rights to Chugai, which is now preparing, but has not decided, a possible return to spinal muscular atrophy development.
Shionogi's amended securities report lowers disclosed compensation for its senior directors to ¥642mn from ¥895mn, driven by a corrected fringe-benefit figure for foreign-national directors; the correction also revises a related-party pay note but leaves other financial-statement figures unchanged.
Japan's health ministry designated Renascience's RS5614 an orphan drug for the rare skin cancer cutaneous angiosarcoma, extending exclusivity and adding a pricing premium, while the company discusses a Phase 3 trial with Japan's PMDA aimed at regulatory approval.
SymBio Pharmaceuticals has signed an exclusive global license with the US Department of Health and Human Services to develop brincidofovir against multiple sclerosis, but the programme remains in animal testing, and the company disclosed no financial terms while saying the deal will not affect its earnings forecast for the year ending December 2026.
Seikagaku Corporation now expects a ¥1.8bn net loss for the year to March 2027, reversing a forecast ¥2.3bn profit, and has cut its full-year dividend from ¥30 to ¥20 per share after telling investors royalty income will fall sharply.
The Osaka biotech's IND filing asks the FDA to clear a US Phase III trial of oremepermin alfa, its lab-made HGF protein already tested through Phase III in Japan for acute spinal cord injury, with the US study not yet started.
SanBio's newly launched cell therapy for chronic motor paralysis after traumatic brain injury, priced at ¥72.7mn a treatment, has generated no revenue and no dosed patients four months after its Japanese launch, and the company is now targeting only six cases by the fiscal year-end in January while its cash pile fell ¥2.34bn to ¥12.75bn over the same half-year.
Kringle Pharma raised its annual sales guidance and narrowed its projected loss for the year to September 2026 after signing an exclusive Japan licensing deal with Maruishi Pharmaceutical for an experimental vocal-fold-scar treatment, under which it will record a ¥100 million upfront fee as revenue this fiscal year, with roughly half of the improved loss forecast coming instead from ¥108 million of development spending that shifted into next year.
Shionogi cleared a Japanese approval adding a booster dose to its Omicron JN.1 COVID-19 vaccine, completing the technical groundwork for supplying future season-matched shots, but the approved formulation itself won't be sold because it doesn't match the strain designated for the 2026-2027 season.
Shionogi and Torii Pharmaceutical secured Japanese approval to prescribe a 0.5% version of their non-steroid eczema cream to children under 12, backed by a trial in patients aged 2 to under 12 showing it beat plain vehicle cream over eight weeks with good long-term tolerability.
Eisai's newly approved subcutaneous Leqembi pen lets patients self-inject weekly at home instead of visiting a clinic every two weeks for IV infusion, but a Central Social Insurance Medical Council review and listing on the injectable drug list must happen first, and Eisai says the approval's effect on its coming-year earnings forecast is minor.
SanBio's cell therapy for chronic traumatic brain injury, known by its development code SB623, cleared its final approval hurdle and reached the market in 2026 with a ¥72mn price tag, yet the company's latest results show no product revenue, a shrinking cash pile, and a 20.29% cut to capital to offset accumulated losses.