Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beam, Hyundai, Regenxbio, Sarepta.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abtherx, Affimed, AFT, Bayer, Endo, Galapagos, Hyloris, Intron, Leap, Mallinckrodt, Qliniq, Single Cell, Vaccinex.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ascendis, Atea, Biorestorative, Cytodyn, Cytokinetics, Enterobiotix, Iteos, Karyopharm, Mediwound, Novo Nordisk, Roche.
U.S. Health and Human Services Secretary Robert Kennedy made his first appearance May 14 before the Senate Health, Education, Labor and Pensions (HELP) Committee since his January confirmation hearing. Chaos, testy arguments, accusations and surprising agreements ensued.
Apimeds Pharmaceuticals US Inc. (APUS), a subsidiary of Kospi-listed Inscobee Inc., said May 12 that it raised $13.5 million from its stock sale on the NYSE American exchange May 9 through an offering of 3.375 million shares at $4 per share. Hopewell, N.J.-based APUS is the second pharmaceutical company with Asian ties to float shares on the U.S. market this year.
Small interfering RNA (siRNA) gained another vote of confidence, albeit back end-loaded, from big pharma as privately held Adarx Pharmaceuticals Inc. signed a deal with Abbvie Inc. related to disease areas that include neuroscience, immunology, and oncology.
Only a few days out of the European Association for the Study of the Liver annual meeting, the metabolic dysfunction-associated steatohepatitis (MASH) space continues to grab headlines, with GSK plc shelling out $1.2 billion up front to acquire phase III-ready efimosfermin alfa in a deal with Boston Pharmaceuticals Inc. that could end up totaling about $2 billion.
In a deal that could top out at about $2.2 billion, Septerna Inc. is getting $200 million up front from Novo Nordisk A/S in a collaboration to develop oral treatments for obesity, type 2 diabetes and other cardiometabolic indications. There will be four programs for discovering, developing and commercializing small molecules targeting G protein-coupled receptors, which includes GLP-1, GIP and glucagon receptors, with both companies putting their shoulders to conducting research from discovery to choice of candidate.
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