Keeping Track: Travere’s Filspari, Chiesi’s Lamzede, Apellis’ Syfovre Headline US FDA Approvals; CRLs For Phathom, Biocon
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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Pink Sheet analysis finds big jump in the share of novel approvals that received PDUFA extensions, largely driven by clinical and safety data submissions.
Second quarter sales of the new geographic atrophy drug exceeded expectations, but the company confirmed seven events of retinal vasculitis in patients treated with Syfovre in the real world.
Public Company Edition: Follow-on offerings did not surge after ASCO, but Day One and Cogent raised $150m-plus. Also, IQVIA and Ionis sold $1.25bn and $500m in notes, while Krystal and Lexicon grossed $160m and $125m from post-approval offerings.