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Keeping Track: Veklury NDA Arrives At US FDA; Olinvyk Sees Approval; MAb Filings By Regneron, Y-mAbs

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

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Public Company Edition: Only nine drug developers went public in the US, raising $807m in the first quarter, versus 32 IPOs raising $5.2bn in Q1 of last year. Also, MoonLake closed its SPAC merger, Sanofi priced €650m in sustainability-linked bonds in €1.5bn note sale, and Kaleido will cease operations.

Y-mAbs Faces Delay In Pediatric Neuroblastoma With Refuse-To-File Letter

Omburtamab, for CNS metastases resulting from neuroblastoma, needs more clinical and CMC data for its rolling BLA to be reviewed. The company says timelines for lead candidate naxitamab should not be affected.

EU Fast-Track Review In Store For Takeda’s Dengue Vaccine

Takeda will soon seek EU approval of its dengue vaccine candidate. The marketing application will be fast-tracked, as will the applications for Regeneron's evinacumab and bluebird bio's eli-cel Lenti-D gene therapy.

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