MoonLake on Track for HS BLA Submission; Relay's Zovegalisib Receives FDA Breakthrough Status
MoonLake Immunotherapeutics says FDA feedback indicates sufficient data to support a U.S. BLA for hidradenitis suppurativa without additional efficacy trials, while Relay Therapeutics received FDA Breakthrough Therapy designation for zovegalisib in combination with fulvestrant for PIK3CA-mutant breast cancer.