Shionogi & Co., Ltd.

Shionogi & Co., Ltd. announced that its Board of Directors approved an agreement to acquire IntraBio Inc., a biopharmaceutical company developing and commercializing therapies for neurodegenerative diseases, for an upfront consideration of USD 2.0 billion payable to IntraBio shareholders. Under the agreement signed on October 5, 2026, IntraBio would become a wholly owned subsidiary of New Jersey-based Shionogi Inc., with the transaction scheduled to close between November 2026 and December 2026, subject to competition-law waiting periods and other customary conditions. The deal would add AQNEURSA (levacetylleucine) to Shionogi's rare disease portfolio; the drug was approved by the FDA in September 2024 for neurological manifestations of Niemann-Pick disease type C and by the European Medicines Agency in January 2026, and on September 18, 2026 it became the first and only FDA-approved treatment for Ataxia in patients with Ataxia-Telangiectasia, for which it is also under EMA review. Shionogi said the acquisition builds on the rare disease foundation it established through its April 2026 acquisition of global rights to edaravone, known as RADICAVA in the U.S. and RADICUT in Japan, and would strengthen its pipeline across Pompe disease, Fragile X syndrome, Jordan's syndrome and early-stage rare neurodegenerative programs. The impact on Shionogi's consolidated financial results for the fiscal year ending March 2027 is currently under review.

Celaid Therapeutics Inc. has completed the second close of its Series B financing round, raising JPY 400 million, approximately USD 2.6 million, through a third-party allocation of new shares. The round welcomed Shionogi & Co., Ltd. and Teikoku Ventures, Inc. as new investors, and Celaid also passed the second stage-gate review of AMED's Strengthening Program for Pharmaceutical Startup Ecosystem, securing selection for Stage 3 funding. With this financing and AMED support, Celaid's cumulative funding raised to date, including grants, now totals approximately JPY 3.42 billion, or approximately USD 22.1 million. Proceeds will be allocated primarily to manufacturing, safety assessment, clinical development, and regulatory activities supporting the IND application for CLD-001, a novel ex vivo-expanded hematopoietic stem cell therapy for severe pediatric non-malignant diseases, and the initiation of clinical trials in the United States. The company said the new participation from pharmaceutical companies represents significant momentum as it advances U.S. development of CLD-001, which has already completed a Pre-IND Meeting with the U.S. Food and Drug Administration.

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.