Gossamer Bio Cuts Costs, Secures FDA Pre-NDA Meeting and Highlights CT FRI Data
GOSS•GOSS•GOSS•GOSS•Gossamer Bio reduced expenses and workforce while securing a pre-NDA Type B meeting with the FDA, targeting late-August analyses and a mid-September NDA filing. CT FRI substudy showed nominal p-values and reverse remodeling signals, while Phase III Procera missed its 0.025 alpha threshold, raising regulatory questions.
Gossamer Bio implemented significant operating expense cuts and a reduction in force to preserve financial stability and extend its cash runway through key regulatory milestones.
The company advanced from a Type C to a Type B pre-NDA meeting with the FDA, planning to finalize NDA analyses by late August and submit the application by mid-September.
Exploratory CT FRI substudy data exhibited nominal p-values with signals of reverse cardiac remodeling, whereas the Phase III Procera trial did not meet the prespecified 0.025 alpha threshold, creating uncertainty around regulatory labeling differentiation.
