After a complete response letter (CRL) from the U.S. FDA in 2022 and approvals in Europe, Japan and Australia, Akebia Therapeutics Inc.’s Vafseo (vadadustat) has finally been approved by the FDA. But the uphill climb still isn’t over for Akebia, as it has more hurdles to clear for the drug. Read More
Boundless Bio Inc. got a lukewarm welcome on Nasdaq after pricing its IPO of 6.25 million shares at the midpoint price of $16 per share, raking in about $100 million in gross proceeds to advance its pipeline of ecDNA-driven drugs targeting oncogene-amplified tumors.
Xilio Therapeutics Inc. retreated with its lead oncology IL-2 drug, XTX-202, after phase II data indicated stable disease was the best response, prompting the company to reprioritize its pipeline and cut its workforce by 21% – but investors focused more on a $647.5 million IL-12 program deal the company signed with Gilead Sciences Inc., as well as an $11.3 million private placement financing. Read More
Novo Nordisk A/S is the latest drug company to be challenged by U.S. Sen. Bernie Sanders (I-Vt.), who has made tilting at prescription drug prices one of the hallmarks of his tenure as chair of the Senate Health, Education, Labor and Pensions (HELP) Committee. Read More
In a potential watershed moment for South Korea’s Hanmi Group, a hair-splitting vote at the 51st shareholder meeting favored the two sons of the late founder and Chairman Lim Sung-ki, effectively halting a merger between Hanmi and OCI Holdings Co. Ltd. Read More
South Korean biosimilar-focused Alteogen Inc. said on March 27 that Chung Hye-shin, former chief strategy officer (CSO) and co-founder, sold 1.6 million of Alteogen shares for ₩316.4 billion (US$234.24 million) to foreign institutional investors. Read More
In February 2024, BioWorld covered 236 updates on phase I-III clinical trials, showing a 6.35% decline from January 2024’s 252 updates. This figure is also lower than February 2023’s count of 258 updates. Throughout 2023, the monthly average of phase I-III updates was 305, with 2024 having an average of 244 in the first two months of the year. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aeterna Zentaris, Aligos, Atea, Beckley Psytech, Biora, Immuneering, Innovent, Kempharm, Kintara, Mendus, Pfizer, PMV. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aeterna Zentaris, Agex, Algernon, Almatabio, Avalon, Bridge, Ceapro, Oncopeptides, Provectus, Serina, Seyltx, Sosei, Vector. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 89bio, Aim, Astrazeneca, Heidelberg, Merck & Co., Norgine, Renexxion, Revive, Santhera, Sillajen, Sperogenix, Syndax. Read More
