Xenon Pharmaceuticals Inc. is delaying the phase III data readout from the X-tole2 trial with azetukalner in focal onset seizures (FOS) from the second half of 2025 to early 2026 but remains busy with NDA plans.
Shionogi & Co. said it plans to acquire Japan Tobacco Inc. (JT) subsidiaries Torii Pharmaceutical Co. and Akros Pharma Inc. for ¥160 billion (US$1.1 billion) to expand its global R&D business. The two companies have been negotiating since early 2024, and the deal is structured such that a tender offer will begin on May 8 and end on June 18 with an offer price of ¥6,350 per share to buy at least 11.89% of the minority stake, JT told BioWorld.
After a week of hype, the most-favored nation (MFN) drug pricing executive order (EO) U.S. President Donald Trump signed May 12 has a lot of bark but little bite, as one analyst put it. Brian Abrahams, head of global healthcare research at RBC Capital Markets LLC, said the EO is unlikely to rattle the biopharma sector, even though it lacked the certainty to completely remove the MFN overhang. “We see reason for relief and, alongside improving FDA clarity and limited tariff risk, expect biopharma to be viewed as increasingly investable,” Abrahams said.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Iaso, Meiragtx, UTR, Verastem.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Garuda, IGM, Kymera, Roche, Sanofi, Stratus, Zealand.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akero, Artax, Astrazeneca, Corvus, Johnson, Leo, Palatin, Volixibat, Vir.