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Latest From Ardelyx Inc.
The latest application submission news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).
FDA is worried about drug names that could appear to overstate efficacy and impact consumer and healthcare provider perceptions of the product.
Public Company Edition: The last biopharma initial public offering in the US was on 11 November, but follow-on and other offerings are generating hundreds of millions of dollars. Among RNA drug developers, Ionis issued more than $500m in new debt, while Arrowhead raised $266.8m.