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NVS - Regenerative Medicine: Does BioMarin Complete Response Letter Change The Outlook?
Novartis AG
BioMarin (BMRN) received a complete response letter or CRL for their hemophilia A gene therapy Valrox last week. As a result, the earliest commercial launch is now in 2023.
Audentes (ALPMF) provided an update on their please 3 neuromuscular ASPIRO clinical trial indicating a third patient treated at the higher dose had passed away. This trial was placed on hold after the second patient died.
Both of these products were expected to be approved in 2020. This is a timely reminder that clinical trials of regenerative medicines are not without