FDA grants Breakthrough Therapy Designation to the company's drug for a rare, fatal pediatric disorder, paving the way for accelerated review and potential approval.
Shares surged in after-hours trading after the company revealed positive results for its lead drug candidate, Telomir-1, in age-related studies.
Nimacimab monotherapy misses primary weight-loss endpoint, though combination with semaglutide shows promise, raising questions for the drug's future.
FDA grants Breakthrough Therapy status for a promising new drug targeting the rare and fatal Sanfilippo Syndrome Type B.
The biotech firm secured its sixth approval for the ZORYVE franchise, expanding its dermatology treatment to children as young as two.
Despite a revenue beat, the semiconductor equipment supplier's net loss and missed earnings per share estimates sent shares tumbling in after-hours trading.
The marketing application for AVT23, a biosimilar to the multi-billion dollar asthma drug Xolair, marks a key regulatory step for Alvotech in the European market.
Investors are closely watching the beverage giant's Q3 results on Monday for insights into the health of the alcoholic beverage market.