Shares of Applied Therapeutics plunged in premarket trading on January 3 after the company announced it is unable to seek regulatory approval of the Galactosemia therapeutic AT-007 at this time.
Lomecel-B – Longeveron’s proprietary off-the-shelf cell therapy for aging frailty – failed the six-minute walk test (6MWT) endpoint of a Phase IIb study, according to a statement published by the Miami-based biotech on Aug. 13.
Shares of Vertex Pharmaceuticals fell in trading after the company announced it will not advance a novel small molecule corrector of the Z-AAT protein into a Phase III study for a rare disease that can lead to complications of the liver and lungs.
Shares of Ovid Therapeutics soared in trading after the company announced pharma giant Takeda signed a licensing agreement valued at $856 million to secure global rights to the investigational medicine soticlestat for the treatment of two forms of rare epilepsy.
Shares of Protalix Biotherapeutics were up in trading after the company announced the Phase III BRIDGE study met key objectives in treating Fabry Disease.
Shares of Axsome Therapeutics were up after the company announced positive long-term results from a Phase III major depressive disorder (MDD) study that sets up potential regulatory approval for AXS-05.
Amgen and AstraZeneca announced that their Phase III NAVIGATOR trial of the potential first-in-class human monoclonal antibody tezepelumab hit the primary endpoint in severe asthma.
Shares of Calliditas Therapeutics soared in trading after the company announced positive Phase III data from a study of Nefecon in IgA nephropatjhy (IgAN), an autoimmune renal disease.
Shares of bluebird bio fell in trading after the company announced that the sickle cell disease gene therapy treatment bb1111 will not be submitted to the U.S. Food and Drug Administration for two more years.
Shares of Cara Therapeutics were up in trading after the company struck a licensing agreement worth up to $290 million with Switzerland’s Vifor Pharma for the commercialization of a treatment for severe itching associated with chronic kidney disease.