Allakos Inc. terminated all development of its lead drug, anti-Siglec-8 antibody lirentelimab (AK-002), and is cutting its workforce in half, following phase II failures for atopic dermatitis and chronic spontaneous urticaria. The San Carlos, Calif.-based company will now focus on phase I trials for anti-Siglec-6 antibody AK-006 as part of a restructuring that stretches the runway into mid-2026. Shares (NASDAQ:ALLK) sank by 60.2%, down $1.80, to close at $1.19 on Jan. 16. Read More
The landscape of biopharma deals and M&As has seen a transformative shift, with a year-over-year drop in transaction numbers while value has increased. Overall, biopharma deals saw an uptick in value of nearly 6%, and biopharma M&As concurrently soared 80% higher in value than the previous year. Read More
Korean confectionary company Orion Holdings Inc. is growing its biotech presence by purchasing a majority stake of 25% in one of the hottest Korean antibody-drug conjugate developers, Legochem Biosciences Inc., although stocks dropped on the news. Under the contract announced Jan. 15, Seoul-headquartered Orion agreed to acquire a 25.73% stake in Daejeon-based Legochem by securing about 9.36 million shares for a total of ₩548.7 billion (US$412.11 million) by the deadline of March 29, 2024. Read More
Axelia Oncology Pty Ltd. was spun out of Ena Respiratory Pty. Ltd., which developed a series of synthetic Toll-like receptor (TLR) 2/6 agonists for nasal delivery to treat respiratory infections, including influenza and SARS-CoV-2. Although the pegylated TLR 2/6 agonist, INNA-051, was initially focused on antiviral activity, the company discovered that it also worked in oncology models, and Axelia was spun out to focus on oncology, CEO Phil Kearney told BioWorld. Read More
The EMA has once again come in behind the U.S. FDA, granting market access to 77 new products in 2023, fewer than half the 157 approvals the FDA processed in the 11 months from January through December 2023. Read More
Though the PDUFA date for its BLA wasn’t until March 30, 2024, Vertex Pharmaceuticals Inc. celebrated the U.S. FDA approval Jan. 16 for Casgevy (exagamglogene autotemcel), expanding use the CRISPR/Cas9 gene-edited cell therapy in patients, 12 and older, with transfusion-dependent beta-thalassemia. Read More
New hires and promotions in the biopharma industry, including: Aclaris, Amring, Cognigenics, Hookipa, ITM, Neurogene, Ocugen, Paratek, Vaxart. Read More
Biopharmas raising money in public or private financings, including: Alto, Cyrano, Defence, Delsitech, Disco, Prota, Stalicla, Vaxart, Xortx. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amryt, Remegen, Santhera, Takeda, Zevra. Read More
