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Aeglea BioTherapeutics, Inc.

https://www.aegleabio.com/

Latest From Aeglea BioTherapeutics, Inc.

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.

United States US FDA Performance Tracker

With 37 Novel Approvals in 2022, US FDA CDER’s Five-Year Hot Streak Comes To An End; Gene Therapies Carry CBER To 8 Novel Approvals

US FDA’s novel agent count fell back to average as agency kept up high rate of complete response letters and refuse to file actions; CBER’s workload shifted to regenerative medicine.

Approvals Drug Review

Novel Brain Penetrant For Treating X-ALD Among Raft Of New EU Filings

Investigational products from Minoryx and a host of other companies targeting a range of diseases are now under review by the European Medicines Agency for potential EU approval.

Europe Approvals

Finance Watch: Recent Upswing Turns Down, But Two Small IPOs Launch

Shuttle Pharmaceuticals and PaxMedica launch two small initial public offerings in the US as the market awaits a significant IPO. Also, Assertio closed a $70m follow-on offering, Codiak restructures and cuts jobs, and Vilya emerges with $50m in series A venture capital. 

Financing Restructuring
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