The biggest M&A activity of the year arrived in the form of Merck KGaA’s earlier-disclosed agreement to buy Springworks Therapeutics Inc. for $47 per share in cash, which represents an equity value of about $3.9 billion and an enterprise value of $3.4 billion, based on Stamford, Conn.-based Springworks’ cash in the bank as of the end of last year. Read More
Shares of CG Oncology Inc. gained 25% April 28 on the back of phase III data presented at the American Urological Association meeting over the weekend showing its cretostimogene grenadenorepvec yielded durable response rates, as well as an enviable safety profile, in patients with high-risk non-muscle invasive bladder cancer unresponsive to Bacillus Calmette Guerin treatment with carcinoma in situ with or without Ta or T1 disease. Read More
Early phase I data for Revolution Medicines Inc.’s RAS(ON) G12D-selective inhibitor zoldonrasib encouraged both the company and the analysts. Initial study data produced a 61% objective response rate in 11 solid tumor patients receiving the 1,200-mg dose once a day. The disease control rate for 16 patients came in at 89%. Read More
The U.S. FDA issued a complete response letter (CRL) to Telix Pharmaceuticals Ltd. for its NDA for glioma imaging agent, TLX-101-CDx (floretyrosine F18 or 18F-FET, Pixclara), citing the need for additional confirmatory clinical evidence. Read More
Argenx NV is now well on the way to establishing a Vyvgart (efgartigimod alfa) franchise in severe autoimmune diseases, after getting the nod from the EMA in the treatment of progressive or relapsing chronic inflammatory demyelinating polyneuropathy. Read More
Jiangsu Hengrui Pharmaceuticals Co. Ltd. is the latest mainland China pharmaceutical company to seek a capital raise on the Hong Kong stock exchange, winning clearance April 28 from the China Securities Regulatory Commission to float new H-shares. Read More
Research of the neuroimmune mechanisms involved in stress-related fear revealed how astrocytes interact with neurons in the amygdala. The study, led by Harvard scientists, also unveiled that this interaction recruited monocytes to the meninges during chronic stress and showed how psychedelic compounds reversed monocyte accumulation in the meninges and reduced fear behavior. Read More
The first 100 days of the Trump administration have been nothing short of chaotic, both in the U.S. and throughout the world. Shining a light through the uncertainty, BioWorld continues to cover the administration’s latest policy decisions and actions affecting the life sciences sector, as well as their impacts across the globe. It’s all right here at Trump administration impacts. Read More
BioWorld is pleased to begin providing a new quarterly dynamic table featuring new molecular entities (NMEs) revealed for the first time in current literature, at congresses and in company communications during the quarter. NMEs include compounds chosen for further pharmacological evaluation or as clinical candidates; new leads whose structural optimization could provide new therapeutic agents; new additions to the structural diversity of known mechanistic classes of drugs; and new pharmacological tools for investigating drug targets. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alx Oncology, Cytoagents, Genentech, Geovax, Neurocrine, Realta, Roche, Vyne. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astex, Caamtech, Caribou, Criceto, Inventiva, Mosaic, Orion, Otsuka, Transneural. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Innocare, J&J, Junshi. Read More
