Aculys Pharma Completes Patient Enrollment for Phase 3 Clinical Trial on Pitolisant in Patients with Narcolepsy
Tokyo, Japan, July 22, 2024 — Aculys Pharma, Inc. (“Aculys”), a clinical-stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, today announced that it has finished enrolling patients for the domestic Phase 3 clinical trial on the histamine H3 receptor antagonist/inverse agonist pitolisant in patients with narcolepsy. Hidemasa Tanigaki, Chief Executive Officer of […]
Renalys Pharma announces first patient dosed in registrational Phase III clinical trial of sparsentan for IgA nephropathy in Japan
TOKYO, JAPAN, July 18, 2024 — Renalys Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; “Renalys Pharma”) announced today that the first person was dosed in its registrational Phase III clinical trial of sparsentan for the treatment of IgA nephropathy in Japan. In April this year Renalys submitted an Investigational New Drug (IND) Application for sparsentan to the Pharmaceuticals and Medical […]
Renalys Pharma Closes ¥6.0Bn Series A Financing to Advance Kidney Disease Treatments Across Asia
Financing Round Co-led by Catalys Pacific and SR One, Investment to Drive the Development of Sparsentan for IgA Nephropathy in Japan and Other Asian Countries TOKYO, JAPAN, July 17, 2024 — Renalys Pharma, Inc., a late-stage clinical biopharmaceutical company has completed a ¥6.0Bn Series A financing. The financing was led by Catalys Pacific and SR One, along with […]
The Japan Kidney Association and Renalys Pharma Form Collaborative Agreement to overcome kidney disease
The Japan Kidney Association, a nonprofit organization, (Headquarters: Bunkyo-ku, Tokyo; “Japan Kidney Association”) and Renalys Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; “Renalys Pharma”) entered into a collaborative agreement on May 1, 2024, with the aim to develop innovative therapies and raise the awareness to overcome kidney disease. “Kidney disease is increasing against a background of changing […]
Aculys Pharma Announces Appointment of Hidemasa Tanigaki as New CEO
～Hidemasa’s appointment bolsters Aculys’ position as a leader in the field of CNS in Japan and Asia～ Aculys Pharma, Inc. (“Aculys”), a clinical-stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, today announces the appointment of Hidemasa Tanigaki as Chief Executive Officer and Representative Director, effective March 29th. Hidemasa has an outstanding track […]
Inventiva announces positive results from the Phase II, LEGEND, Proof-of-Concept study combining lanifibranor with empagliflozin in patients with MASH/NASH and T2D
Aculys Pharma receives orphan drug designation for a diazepam nasal spray: an antiepileptic drug for epileptic seizures
Tokyo, Japan, November 24, 2023 — Aculys Pharma, Inc., a clinical stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, today announced that a diazepam nasal spray (compound development code: NRL-1), an antiepileptic drug currently under development for the treatment of epileptic seizures, has been designated as an orphan drug by the Ministry of Health, Labour […]
Aculys Pharma Announces Leadership Change
Aculys Pharma, Inc. (“Aculys”), a clinical stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, today announced that Kazunari Tsunaba will be leaving his position as Chief Executive Officer. Takeshi Takahashi, a co-founder, and a member of the Board will be acting as interim Chief Executive Officer effective immediately. Mr. Takahashi will lead […]
Inventiva and Hepalys Pharma, Inc. announce exclusive licensing agreement to develop and commercialize lanifibranor in Japan and South Korea
• Hepalys Pharma, Inc. is a new company created by Catalys Pacific and in which Inventiva has a 30% ownership position.• Under the exclusive licensing agreement, Inventiva will receive a $10 million upfront payment, and is eligible to receive up to $ 231 million in clinical, regulatory and commercial milestone payments in addition to tiered […]
Aculys Pharma delivers positive Phase 3 clinical study interim analysis result of a diazepam nasal spray: an antiepileptic drug for the treatment of epileptic seizures
These results are from Japan’s first domestic Phase 3 clinical trial of an intranasally administered antiepileptic drug for Japanese patients aged 6 to 17 for the treatment of status epilepticus or epileptic seizures that may lead to status epilepticus. The primary efficacy endpoint was met in a pre-specified interim analysis, and the drug was found […]