Stock Watch: 2022 Starts Badly For Biotech
The Usual Early-Year Flurry Of Good News Is Absent
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.
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Avrobio is sidestepping market and regulatory issues in Fabry disease by suspending development of AVR-RD-01, but says it remains focused on advancing treatment of lysosomal storage disorders with gene therapies.
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.
It takes a lot of negotiation with regulators, advisory boards, and alignment between commercial and portfolio management teams to define and agree a clinical trial protocol. Why on earth would companies change it once a study is underway?