The company said it will update investors on the path forward for zuranolone in major depressive disorder after finalizing discussions with the US FDA. It would not confirm if a meeting had taken place yet.
Sage Therapeutics Inc. investors eager for an update on the regulatory strategy for zuranolone (SAGE-217) in major depressive disorder will need to be patient. During the firm’s fourth quarter sales and earnings call on 27 February, Sage said it has not yet figured out the best path forward for filing the product with regulators.
An update will come later this year based on the outcome of a first quarter meeting with the US Food...
GLP-1 receptor agonists could play a big role in tackling neurodegeneration and a new academic study has raised expectations of Novo Nordisk’s latest semaglutide Phase III results
Amgen’s Imdelltra for small-cell lung cancer is one of two bispecific T-cell engagers approved for solid tumors, but data at the WCLC meeting show other DLL3-targeting BiTEs may be on the way.
An academic study of GLP-1 agonist showed promise in patients with the painful skin condition but with no signs that the Danish drugmaker will pursue the indication, smaller players in the space may be interested.
As it posts third-quarter numbers that again reveal the decline of revenues from its multiple sclerosis portfolio, the US biotech major is entering into the hot area of targeted protein degradation to boost its immunology and neurology pipeline.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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