Phase III
The funding agreement comes as Biogen revealed a modest Q4 sales beat, which analysts expect will be “overshadowed” by the company’s forecasted dip in 2025 revenues.
Nerandomilast, an oral phosphodiesterase 4B inhibitor, hit the primary endpoint in a Phase III trial in progressive pulmonary fibrosis—nearly six months after achieving a similar feat in idiopathic pulmonary fibrosis. Boehringer plans to submit for FDA and other global approvals in both indications.
It is unclear why an independent data safety monitoring board recommended the suspension of Pliant’s Phase IIb/III BEACON-IPF study in idiopathic pulmonary fibrosis.
Novo Nordisk’s bispecific antibody Mim8 prevented bleeding events and caused no adverse safety events in the Phase III FRONTIER3 trial. The company plans to file for approval this year, hoping to compete in the hemophilia A space with Roche’s blockbuster Hemlibra.
Novo Nordisk shares tumbled last year when obesity candidate CagriSema failed to clear a weight loss bar of 25%. Now, executives are taking another look at the data but steering clear of making hard bets.
APAC offers stability in an increasing challenging global geopolitical environment for clinical stage drug development.
Topline data on a combo including Pfizer’s kinase inhibitor Braftovi point to improved progression-free survival and pave the way for its full approval for the treatment of certain colorectal cancers, according to the company.
Bristol Myers Squibb’s Opdivo plus Yervoy, as well as Pfizer’s Braftovi, have each shown strong Phase III performances that could position them as new standards of care in certain subtypes of metastatic colorectal cancer.
Riding recent momentum in the Duchenne muscular dystrophy space, Capricor Therapeutics, Wave Life Sciences, Regenxbio and more aim to deliver the next wave of progress with near-term data and regulatory milestones.
Achondroplasia, which affects around one in 20,000 babies, has just one approved treatment: BioMarin’s Voxzogo. However, new investigational treatments are vying to compete in the area.
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