Analyst confidence swells following positive FDA alignment on the company's pivotal gene therapy trial for Rett Syndrome.
Permanent J-Code from CMS aims to streamline reimbursement and broaden patient access for its graft-versus-host disease treatment.
Genentech's Tecentriq combination therapy is the first maintenance treatment for extensive-stage small cell lung cancer, a significant advance in a hard-to-treat disease.
Regulators express significant doubts over the company's lead drug candidate, avacopan, sparking a massive investor sell-off.
The new oral treatment addresses chronic spontaneous urticaria in patients unresponsive to antihistamines, driving shares up over 2.7%.
Company receives a Complete Response Letter for its Menkes disease treatment, CUTX-101, citing manufacturing issues, not safety or efficacy concerns.
Designation aims to speed development of novel tau-targeting antibody for early-stage Alzheimer's disease.
Disappointing Phase 3 data for its lead drug sonelokimab triggers massive sell-off and analyst downgrades, erasing billions in market value.