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The decision to maintain or revoke breakthrough therapy status when trial results do not appear to support the original designation will depend on the facts specific to a development program, the US FDA says in new draft guidance. Since 2012, the agency has granted 475 breakthrough therapy designation requests and rescinded 35 designations.
Hot on the heels of an oversubscribed series B round, OMass CEO and Rising Leader Ros Deegan spoke with In Vivo about her move from pharma to biotech, mass spectrometry and big dreams for the firm.
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.
With 46 initial public offerings in the US by drug developers so far – including recent launches by Kymera, Inhibrx and Harmony – 2020 will easily beat last year’s 50 IPOs. In follow-on offerings and VC deals, newly public Schrodinger raised $346.5m and Tango’s $50m equity financing.
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