Keeping Track: Submissions From Alkermes, Samsung Bioepis; BTDs for Orphazyme and Kiniksa
The latest submission and expedited review program news and highlights from our US FDA Performance Tracker.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Public Company Edition: iTeos, Annexon, Nurix and Inozyme went public on 23 July and now CureVac has added its name to the IPO queue for what could be a large offering. Also, BioNTech raises $511.5m as COVID-19 vaccine progresses and PTC gets $650m from sale of risdiplam royalties.
Public Company Edition: Moderna leveraged its all-time high stock price to raise $1.34bn on the same day it reported data from a Phase I trial of its COVID-19 vaccine. Several other companies also took advantage of biopharma’s rising value.