Phase I trial consists of two parts. Part A is a single ascending dose (SAD) study of ASC35 once-monthly Self-Assembling Lipid Depot (SALD) formulation; Part B is a head-to-head study of multiple ascending doses (MAD) of ASC35 once-monthly SALD formulation compared to the U.S. Food and Drug Administration (FDA)-authorized tirzepatide once-weekly formulation. In head-to-head non-human primate (NHP) studies, the average observed half-life of ASC35 was approximately six-fold longer than tirzepatide

Pfizer Inc. (NYSE: PFE) today announced topline results from the Phase 3 SigVie-002 study (previously known as Be6A Lung-01) evaluating sigvotatug vedotin, an investigational, potential first-in-class integrin beta-6 (IB6) directed antibody-drug conjugate (ADC). The study enrolled adults with locally advanced, unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) who had received one or more lines of prior therapy. In the overall population, sigvotatug vedotin did not show

This trial is the first large, placebo-controlled clinical trial of an acid suppression treatment in EoE Topline results for the double-blind 12-week treatment portion of the study are expected in Q4 of 2026 June 23, 2026 -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced it has completed enrollment in its Phase 2 pHalcon-EoE-201 clinical trial evaluating VOQU

ORION CORPORATION PRESS RELEASE 23 JUNE 2026 at 9:30 EEST Orion Pharma’s ODM-212 Granted Orphan Designation for the Treatment of Malignant Mesothelioma by the European Commission Orion Corporation (Orion Pharma) today announced that its investigational drug ODM-212 has received Orphan Designation from the European Commission, based on the recommendation from the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP), for the treatment of malignant mesothelioma, which

June 19, 2026 -- Zenyaku Kogyo Co., Ltd. (website in Japanese only) and Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that Zenyaku, the marketing authorization holder, obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW), for an additional dosage and administration*1 of an anti-CD20 monoclonal antibody Rituxan® intravenous infusion 100 mg and 500 mg [generic name: rituximab (genetical recombination)] (hereafter “Rituxan”), which is co-promoted by bo

Incyte Biosciences Japan G.K. today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Minjuvi ® (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). “This approval provides a new option for patients in Japan living with relapsed or refractory DLBCL, an aggressive disease with historically limited treatment options,” said Yasuyuki Ishida, General Manager, Incyte Biosciences Ja

June 19, 2026 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it filed a regulatory application with the Ministry of Health, Labour and Welfare for sparsentan for the treatment of patients with IgA nephropathy. “In IgA nephropathy, a designated intractable disease, there are patients in whom proteinuria is not adequately controlled with existing treatments, and long-term decline in kidney function has remained an unmet challenge. Sparsentan has a novel mechanism of action

Provides a new treatment option as the world’s first therapeutic drug for neurofibromatosis type 2, a disease with limited treatment options Approval based on the results from an investigator-initiated Japanese Phase II clinical study June 19, 2026 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) today announced that it received regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the additional indication of neurofibromatosis type 2 (NF2) for the anti-cancer agent/hum

Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, and Merz Therapeutics GmbH, a leading player in neurology-focused specialty pharma, jointly announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the additional indications for XEOMIN® (incobotulinumtoxinA) for the treatment of cervical dystonia and blepharospasm. This approval represents the fourth and fifth indications for XEOMIN® authorized in Japan, alongside its existing appr

Kovina Therapeutics Inc. today announced publication in the Proceedings of the National Academy of Sciences (PNAS) of research validating its HPV E6 targeted therapeutic approach. The publication, “Covalent Inhibitors of Human Papillomavirus Type 16 E6 Protein Restore p53 Function and Suppress Growth of HPV-Driven Tumors in vivo,” reports that small molecules developed through Kovina’s HPV E6 program restore p53 tumor suppressor activity, induce apoptosis and senescence in HPV-positive cancer c