Spruce Biosciences ($SPRB) is on one of the most dramatic runs in biotech this year. Shares have surged nearly 2,900% over ...

The microcap biotech stock had its best day ever after the FDA granted its rare-disease drug a breakthrough designation.

BeOne Medicines said the Food and Drug Administration has granted Breakthrough Therapy Designation for sonrotoclax for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.

New analysis from Jefferies shows that rare disease and cancer drugs granted the status are especially likely to be approved.