A slow start to the year in health care is usually tempered by announcements that build up to investor conference season. However, early 2022’s plethora of negative announcements may continue biotech’s unloved status of 2021.

Analysts’ fears have been confirmed as a US FDA demand for clinical outcomes data has forced Applied Therapeutics to delay a planned filing for its lead product candidate, AT-007, in the rare disease galactosemia based on biomarker data alone.

Blueprint and Zymeworks raise $300m-plus in follow-on offerings. Also, Arcutis, Black Diamond and Annovis bring the 2020 US IPO count to four; Spring Bank, Surface Oncology and Decibel reveal strategic shifts; and Harmony’s $200m in venture debt leads recent VC deals.

Applied Therapeutics has a business model that defies the conventional wisdom about start-up success: reviving science abandoned by big pharma; financing from a narrow group of investors, dependent on the goodwill of a single academic institution; all in pursuit of a small molecule solution to one of the biggest, diversely complex and cost-defying challenges in chronic disease – the complications of diabetes.