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.
Sirius Therapeutics Inc. raised nearly $50 million in a series B2 financing round May 9 to support its pipeline of small interfering RNA (siRNA) molecules for cardiovascular disease indications. SRSD-107, a long-acting Factor XI anticoagulant for thromboembolic disorders, is its lead candidate waiting on EMA clearance to begin a phase II study in Europe.
Minghui Pharmaceutical Ltd. is out-licensing its antibody-drug conjugate (ADC) MHB-088C to Qilu Pharmaceutical Co. Ltd. for China rights for up to ¥1.345 billion (US$186.44 million). Under terms of the deal, Qilu gains rights to develop and manufacture the ADC in greater China, including mainland China, Hong Kong, Macau, and Taiwan.