The NETTER-2 trial included patients with newly diagnosed SSTR-positive, Grade 2 and 3, advanced gastroenteropancreatic neuroendocrine tumors.
Drugs in the Pipeline
NXC-201 is an autologous BCMA-targeted investigational chimeric antigen receptor T cell therapy.
Pegozafermin is an investigational glycoPEGylated analog of FGF21.
MWTX-003 is an investigational anti-TMPRSS6 designed to induce endogenous expression of hepcidin resulting in suppression of serum iron levels.
REL-1017 is an investigational oral, novel N-methyl-D-aspartate receptor channel blocker.
Given the new requirement, ARS expects to resubmit the NDA for neffy in the first half of 2024.
The sBLA was based on efficacy and safety data from the KEYNOTE-A18 trial.
The INTEGUMENT-PED trial included 652 children 2 to 5 years of age with mild to moderate atopic dermatitis who had a mean BSA of 22% and a range from 3% to 82%.
Belzutifan is a hypoxia-inducible factor inhibitor.
The Company anticipates making the product available in the second half of 2024 or early 2025, if approval is granted.
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