- Pfizer Inc (NYSE:PFE) announced that an interim futility analysis of the global Phase 3 trial, REALM-DCM of PF-07265803, indicated the trial is unlikely to meet its primary endpoint upon completion.
- Based on these results, the Phase 3 trial and further development of PF-07265803 will be discontinued. This decision is not based on safety concerns.
- Patients enrolled in the Phase 3 trial will stop study medication and complete any necessary follow-up evaluations. Detailed data from the REALM-DCM study will be presented at future medical meetings to help inform ongoing research.
- The asset was added when Pfizer acquired Array BioPharma for $11.4 billion in 2019, mainly focused on oncology but included a few non-cancer assets, including a Phase 3 drug being tested in a rare cardiovascular disease.
- Pfizer was testing PF-07265803, formerly ARRY-797, in patients with symptomatic dilated cardiomyopathy (DCM) due to a mutation of the gene encoding the lamin A/C protein (LMNA).
- LMNA-related DCM involves left ventricular enlargement and/or reduced systolic function. Arrhythmias and conduction system disease also sometimes accompany the rare inherited condition.
- Price Action: PFE shares are down 0.22% at $49.75 during the market session on the last check Thursday.
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