Keeping Track: Furoscix, SPN-830 Show Difficulties Of Drug-Device Combinations
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Public Company Edition: Aileron, Talaris and Frequency said they will reduce expenses and seek options for maximizing shareholder returns under tough stock market conditions. However, CureVac and Supernus are among firms recently able to access new cash – $250m and $150m, respectively.
Public Company Edition: Prime Medicine raised $175m, making its offering the sixth-largest out of 19 biopharma IPOs in the US this year. Also, Oculis and AUM opted to go public via SPAC mergers, Insmed raised $775m from multiple financings and Dice capitalized on positive data with a $300m offering.
Intarcia and Lexicon fail to convince FDA's Center for Drug Evaluation and Research to grant hearings after complete response letters. Intarcia contends that kidney injury with its diabetes drug implant is similar to Novo Nordisk’s Wegovy, while Lexicon argues that CDER did not adequately consider a REMS when reviewing its SGLT2 inhibitor.