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Latest From Ardelyx Inc.

Finance Watch: Big Bucks For T-regs In Autoimmune Diseases, Inflammation

GentiBio closed a $157m series A venture capital round, while clinical trial innovator Reify Health raised a $220m series C and Neurelis secured $150m. Also, IPOs slowed in August, but Adagio and Eliem grossed $309.4m and $80m, respectively, and RNA firm Greenlight will go public in a $282m SPAC deal. 

Financing Innovation

Keeping Track: US FDA Approvals Of Saphnelo, Nexviazyme Balanced By CRLs For Rolontis, Treosulfan, Tenapanor

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Ardelyx’s Tenapanor Hits Another Regulatory Stumbling Block On Label, Post-Marketing Commitments

While not an outright rejection, the Deficiencies Preclude Discussion letter came as a surprise given the expectation of the drug’s approval for hyperphosphatemia in adults with chronic kidney disease on dialysis.

Drug Review Regulation

April User Fee Goal Calendar: Forecast Uncertain For Atopic Dermatitis Candidates, Nuplazid; Eohilia Could Be First For Orphan Use

While some of the most prominent applications with user fee goal dates in April could be delayed, thanks to JAK inhibitor safety concerns and US FDA communications, the upcoming month should see more than 15 decisions on applications.

Complete Response Letters Approvals
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