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Keeping Track: Showers Of Approvals In US FDA’s May Forecast

Executive Summary

Upcoming user fees include 16 novel agents, featuring two RSV vaccines, two gene therapies, and three oncologics. The Pink Sheet’s US FDA Performance Tracker breaks down the big month to come.

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Finance Watch: Two Biopharma IPOs Bring US Total To 17

Public Company Edition: Neumora grossed $250m and RayzeBio raised $311m in the first initial public offerings since early August. Also, ImmunityBio completes $470m in equity and debt financings, Bausch + Lomb sells $1.4bn worth of notes and Arbutus is among firms making cuts to conserve cash.

Finance Watch: Kenvue, Acelyrin Launch Biggest Biopharma IPOs Of 2023

Public Company Edition: J&J’s consumer health spinout Kenvue grossed $3.8bn in its public market debut and Acelyrin raised $540m in an upsized IPO. Also, Seres accessed $250m in new debt for Vowst commercialization while follow-on offerings raised $325m for ImmunoGen and $240m for Morphic. 

Finance Watch: Mega-Rounds Make A Comeback, But Will VC Funding Totals Rise Too?

Private Company Edition: Venture capital mega-rounds of $100m or more held steady in April after a slow January and February then a surge in March, but VC fundraising is down overall this year. In recent raises, Enveda series B expanded to $119m, Vedanta brought in $106.5m and Convergent raised $90m.

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