Onconic Therapeutics Inc., a subsidiary of Jeil Pharmaceutical Co. Ltd., saw its shares (KOSDAQ:476060) ascend for two consecutive days after debuting with a ₩20.15 billion (US$13.89 million) IPO on the Korea Exchange Dec. 19. Seoul, South Korea-based Onconic’s Kosdaq IPO offered about 1.55 million shares at ₩13,000 each, which was lowered from its original price band of ₩16,000 to ₩18,000 per share after demand forecasting.
Shares in Zealand Pharma A/S (CO:ZEAL) dropped 22.4% to as low as DKK587 (US$82.16) on Dec. 20, after the U.S. FDA issued a complete response letter (CRL) for glepaglutide in the treatment of short bowel syndrome.
The potential for TL1A-targeting duvakitug to impact unmet needs of patients with ulcerative colitis (UC) and Crohn’s disease (CD), and to provide antifibrotic effects for a host of other diseases, boosted shares of Teva Pharmaceutical Industries Ltd. and Sanofi SA by 26.5% and 6.7%, respectively, as the partners released what analysts called “best-in-class” results from the phase IIb Relieve UCCD study and prepare for a phase III trial in 2025.
The EMA’s Committee for Medicinal Products for Human Use recommended 17 drugs for approval at its December meeting, bringing the total for 2024 to 114. That is up from the 77 drugs recommended for approval in 2023, of which 39 were novel.
South Korean billionaire and chairman of Celltrion Group Jungjin Seo is returning Celltrion Inc. to its contract manufacturing organization (CMO) roots, as it relies on biosimilar sales to anchor the company in a fiercely competitive novel drug R&D arena.
Many studies have linked the presence of specific bacteria to various diseases. But a general overgrowth of gut bacteria can be a symptom of different conditions, including colorectal cancer and inflammatory bowel disease.
An international consortium of thousands of scientists is creating the Human Cell Atlas, a three-dimensional map of all the cells in the body. The goal is to understand all the cells that make up human tissues, organs and systems, which will enable multiple medical applications. This collection of cell maps is openly available for navigation at single-cell resolution, identified through omics analyses that reveal the tridimensional distribution of each cell.
Advertisements for Rezdiffra (resmetirom, Madrigal Pharmaceuticals Inc.), which was approved by the U.S. FDA in March 2024, adorned the lobby of The Liver Meeting 2024 being held at the San Diego Convention Center as well as the trolley stop across the street and other areas that doctors attending the meeting might be swayed. But inside the ballrooms of the convention center, companies were making presentations of data from clinical trials testing their drugs in patients with metabolic dysfunction-associated steatohepatitis (MASH) in hopes of potentially competing with Rezdiffra in a few years.
Microbiome specialist Enterobiotix Ltd. has reported positive results for the phase Ib trial of its EBX-102 fecal microbiota therapy in patients with stable liver cirrhosis. The placebo-controlled study involved first-in-human dosing with the company’s encapsulated oral formulation of microbiota derived from the stools of healthy donors. After initial dosing, patients were followed up for 12 weeks to assess changes in a range of clinical and blood biomarkers.
OSE Therapeutics SA has reported positive data for lusvertikimab in a phase II trial in ulcerative colitis, boosting the monoclonal antibody’s prospects of becoming the first anti-interleukin-7 therapy to reach the market.
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