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Shionogi & Co., Ltd.

Shionogi & Co., Ltd. researches, develops, manufactures, and distributes pharmaceuticals, diagnostic reagents, and medical devices in Japan and internationally. It also operates in consumer healthcare and provides services including contract research support, analytical testing, agricultural material testing, and IT solutions for medical and healthcare-related issues. The company was formerly known as Shionogi Shoten Co., Ltd. and changed its name to Shionogi & Co., Ltd. in 1943. Founded in 1878, it is headquartered in Kita, Japan.

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News & notes moving 4507.JP
4507.JP

Verrica Pharmaceuticals Doses First U.S. Patient in Second Pivotal Common Warts Trial

Verrica Pharmaceuticals announced that the first U.S. patient has been dosed in COVE-3, the second pivotal clinical trial of its global Phase 3 program evaluating YCANTH for the treatment of common warts. The company's Japanese development partner, Torii Pharmaceutical, also recently dosed the first Japanese patient in the same study. The Phase 3 program consists of two double-blind, randomized, vehicle-controlled trials, with COVE-2 enrolling only in the U.S. and COVE-3 enrolling in both the U.S. and Japan. Verrica noted that COVE-2 has already surpassed 50% of its targeted U.S. enrollment, and a long-term follow-up study, COVE-4, is also underway. If approved, YCANTH would be the first FDA-approved therapy for common warts, a condition affecting an estimated 22 million people in the U.S. alone.
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Biotech & Genomic Medicineimpact 4

F2G and Shionogi report positive Phase 3 results for oral antifungal olorofim in invasive aspergillosis

F2G and Shionogi announced that the global Phase 3 OASIS study of the investigational oral antifungal olorofim met its primary endpoint of non-inferiority against AmBisome followed by standard of care in patients with invasive aspergillosis refractory to or unsuitable for azole therapy. The all-cause mortality rate at Day 42 was 23.8% for olorofim and 24.3% for the comparator arm, a difference of -0.5 percentage points with a 95% confidence interval of -13.1 to 10.8%. Drug-related treatment-emergent adverse events occurred in 35.8% of olorofim patients versus 63.9% in the AmBisome arm, with the difference mainly driven by a higher rate of renal events in the comparator group. If approved, olorofim would be the first novel mechanism agent for invasive aspergillosis in more than 20 years. F2G and Shionogi plan to submit the data to regulators, with F2G responsible for the U.S. and Shionogi for Europe and Asia.
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