Regenerative medicine company Mesoblast Ltd. is preparing to launch its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil, (remestemcel-L), in March in the U.S. and has priced the treatment at roughly $1.55 million for a full course.
Qyuns Therapeutics Co. Ltd.’s monoclonal antibody targeting IL-17A, QX-002N, met both primary and secondary endpoints in a phase III trial in ankylosing spondylitis.
Nearly four years after signing its first major partnership with Takeda Pharmaceutical Co. Ltd., Bridgene Biosciences Inc. returned for a second deal with Takeda – this time focused on using its chemoproteomics platform to discover novel small molecules against immunology and neurology targets.
The first clinical data from an FDA-approved trial of a CAR T-cell therapy in the treatment of multiple sclerosis (MS) show the cells cause complete B-cell depletion, leading on to a reset of the immune system that is accompanied by an improvement in symptoms.
Septerna Inc.’s stock plunged as much as 68% throughout the day Feb. 18 on news that the company was stopping a phase I trial of SEP-786 in healthy volunteers following two severe events of elevated unconjugated bilirubin in the highest dose cohort of the multiple ascending-dose portion of the study.
Becoming the second drug approved by the U.S. FDA for tenosynovial giant cell tumors, Deciphera Pharmaceuticals Inc.’s oral CSF1R inhibitor vimseltinib, newly branded Romvimza, could take significant market share from a competitor in the same class. A phase III trial showed a higher objective response rate with Romvimza than a separate phase III trial showed with Daiichi Sankyo Co. Ltd.’s Turalio (pexidartinib), and the latter’s label contains a boxed warning on rare but serious and sometimes life-threatening liver side effects.
In a deal that Cantor Fitzgerald analyst Eric Schmidt characterized as “capital recycling at its best,” Alumis Inc. and Acelyrin Inc. are merging in an all-stock transaction. The combined pipelines include Alumis’ most advanced prospect, ESK-001, an oral, next-generation, allosteric inhibitor of tyrosine kinase 2 (TYK2). ESK-001 is undergoing the phase III Onward study for moderate to severe plaque psoriasis as well as the phase II Lumus bid in systemic lupus erythematosus.
Scientists at the University of Pittsburgh have tested a broadly neutralizing antibody that binds the stem of a protein against H5N1 avian influenza, which prevented severe disease in nonhuman primates and was effective for at least 8 weeks. The scientists remark on the potential of the design developed by Astrazeneca plc against a possible outbreak of the influenza A virus.
The liver and pancreas are the main actors in glucose metabolism, but not the only ones. Muscles, adipose tissue and the brain play different roles. However, the prize for the best new actor in glucagon production goes to the innate lymphoid cells (ILCs), which, according to a study published in Science, respond to intestine neuron signals traveling to the pancreas to control glucose.
Neomorph Inc. has signed another billion-dollar deal to develop molecular glue degraders, this time with Abbvie Inc. It’s the third agreement in the past year the five-year-old company has signed with big pharma companies in a space with lots of collaborative deals.
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