FDA Requests More Data for Joenja in Younger Children with APDS
Pharming (PHAR) receives FDA Complete Response Letter for Joenja (leniolisib) in children aged 4-11 with APDS. Additional data needed on dosing and testing methods.
Pharming (PHAR) receives FDA Complete Response Letter for Joenja (leniolisib) in children aged 4-11 with APDS. Additional data needed on dosing and testing methods.
Guggenheim starts coverage of Avalo Therapeutics with a Buy rating, highlighting AVTX-009 as a promising IL-1beta treatment for Hidradenitis suppurativa (HS) and $2.1B peak sales potential.
FDA reveals it warned Corcept Therapeutics multiple times about relacorilant's approval issues before the company submitted its Cushing's syndrome drug application.
ALX Oncology announces $150 million stock offering to advance clinical trials for evorpacept and ALX2004 cancer therapies with support from major investors.
Mizuho and Jefferies initiate coverage on Pulse Biosciences and enGene, highlighting growth potential, strong clinical data, and upcoming catalysts in biotech.
Craig-Hallum initiates coverage of Aclaris Therapeutics with a Buy rating and $10 target, noting upcoming 2026 readouts and potential in ATI-052.