Earnings, deals and disclosures from Japan's listed pharma & healthcare companies, in English.
Eisai and Biogen launched a self-injectable weekly Leqembi pen in Japan at a listed ¥27,141 per pen, with first doses still given at a medical facility, MRI monitoring unchanged and Eisai's guidance untouched.
MSD has begun a Phase 1 trial of a PDPS-derived peptide candidate for inflammatory disease, and PeptiDream expects to book an undisclosed milestone fee as fourth-quarter revenue, already within its full-year forecast.
Otsuka says its final two-year VISIONARY data show one composite kidney event among 259 VOYXACT patients against 28 among 251 on placebo, and a supplemental FDA filing seeking full approval is complete.
A Japanese drug panel concluded Steboronine can be approved for recurrent meningioma, but formal approval is pending, and Stella Pharma expects only a slight effect on earnings in the year to March 2027.
Kringle Pharma said the FDA review of its IND for oremepermin alfa has ended and the application is in effect; the company is preparing a US Phase III trial in acute spinal cord injury, with no partner or start date named.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.