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Latest From ImClone Systems, Inc.
‘Do It Or We’re Not Going To Approve Your Drug:’ Industry Reps Ask FDA For Trial Diversity Sticks
FDA leadership has generally seemed apprehensive of going too hard on companies that don’t meet clinical trial diversity goals, but some industry insiders say a stronger FDA is needed to spark real change. Delayed guidance could indicate if the agency will change course.
Chinese Drug Makers Trim, Boost Pipelines In New R&D Drive
The ranks of B7-H3-targeting antibody-drug conjugates under development in China have seen their first dropout, although elsewhere there are two FGFR2b-directed ADCs with first-in-class potential on the horizon. Meanwhile, there have been other discontinuations of KRAS G12C inhibitors and anti-BCMA CAR-T cell therapies in the country, while new players have surfaced in the areas of mRNA cancer vaccines and amyloid-beta-targeting antibodies for Alzheimer’s disease.
Finance Watch: Ten IPOs So Far In 2024, But Returns To Date Are Subpar
Public Company Edition: This year’s newly public companies are trading an average of 9.7% below their IPO prices, including the two most recent debuts, Boundless Bio and Contineum. Also, Nkarta, Praxis and Nurix grossed $240m, $200m and $175m, respectively, in follow-on offerings.
Venture Capital Fundraising Rebounds In Q1 As Mega-Rounds Dominate
Biopharma firms raised $6bn in the first quarter of 2024, the most of any quarter since Q2 2022. But without an increase in the number of companies raising funds, the rebound remains uneven.
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