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MYQORZO FDA Approval
Cytokinetics receives FDA approval for MYQORZO (aficamten) in adults with symptomatic obstructive hypertrophic cardiomyopathy.
Relacorilant CRL
FDA issues a Complete Response Letter for Corcept’s relacorilant NDA for hypertension secondary to hypercortisolism.
RGX-111 and RGX-121 Clinical Holds
FDA places REGENXBIO’s RGX-111 and RGX-121 MPS gene-therapy programs on clinical hold following a reported tumor case.
PROPEL 3 Topline Results
BridgeBio reports positive Phase 3 PROPEL 3 results for oral infigratinib in children with achondroplasia.
ORBIT and COSMIC Endpoint Misses
Mereo reports that setrusumab missed the primary fracture-rate endpoints in the Phase 3 ORBIT and COSMIC studies.
Zanidatamab License Agreement
Jazz signs an HSR-conditional exclusive license agreement with Zymeworks for zanidatamab across specified territories.
Intra-Cellular Therapies Acquisition
Johnson & Johnson agrees to acquire Intra-Cellular Therapies for approximately $14.6 billion in equity value.
Corcept–Teva Noninfringement Ruling
The Federal Circuit affirms the noninfringement ruling concerning Teva’s generic Korlym and two Corcept patents.
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