Keeping Track: Approvals For Phexxi, Kynombi; New Claims For Lynparza, Alunbrig, Tecentriq; Intercept May Miss NASH User Fee Date
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.
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With help from Biomedtracker, Scrip takes a look at six drug candidates expecting pivotal data by the end of the year. The assets span a range of therapeutic areas, from ophthalmology to neurology, and are poised to become market firsts, rivals to dominant products or win important label expansions.
Adamis got its second complete response letter for Zimhi. While not apparently related to the first, it may complicate the company's outlook following a lackluster quarter.
Public Company Edition: Codiak, Kiromic, Aligos and Opthea have fallen below their initial public offering values, while Tarsus and Praxis are trading higher. Also, 5AM, MPM and Cormorant took biotech SPACs public and Evotec led recent non-IPO financings with a €250m private placement.