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Aerovate Therapeutics reported its full-year 2021 financial results, highlighting the progress of its Phase 2b/Phase 3 trial of AV-101 in PAH and its financial position with $167.4 million in cash, cash equivalents, and short-term investments.
Initiated global Phase 2b/Phase 3 trial of AV-101 in PAH in December.
Received orphan drug designation from the FDA and EMA for AV-101 for the treatment of PAH.
FDA guidance supports 6MWD as primary endpoint for Phase 3.
Raised $126.9 million in net proceeds from IPO.
Aerovate expects that its cash, cash equivalents and available-for-sale investments will be sufficient to fund operations into the second half of 2025, based on the current operating plan.