Mirum’s Long-Term Alagille Data Support Case For Early Filing
Newly public Mirum hopes to file maralixibat for US approval in pruritus due to Alagille syndrome based on Phase IIb data, including long-term extension data reported at AASLD.
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With $120m in Series A funding, the new company headed by former Lumena execs will advance maralixibat into Phase III in Alagille syndrome and progressive familial intrahepatic cholestasis. Shire acquired Lumena for $260m in 2014, but lost interest in the drug.
Shire's Phase II IMAGO trial of SHP625 in 20 pediatric patients with Alagille syndrome (ALGS) has failed to meet its primary or secondary endpoints.
Pharma sells the rights to Germany’s Cheplapharm, which obtained EU/Russia rights in October. Cerecor will acquire Aevi Genomics for $16.1m plus contingent value rights.