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Aerovate Therapeutics Announces Second Quarter 2021 Financial Results
WALTHAM, Mass. , Aug. 16, 2021 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical stage biopharmaceutical company focused on
About this update from Jade Biosciences, Inc.
[{"type":"text","content":"WALTHAM, Mass. , Aug. 16, 2021 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease, today announced its financial results for the quarter ended June 30, 2021, and recent events. “It has been an exciting quarter for Aerovate as we received scientific advice from the EMA, received regulatory guidance from the FDA at our end-of-Phase 1 meeting, and we expect to initiate enrollment this year in the Phase 2b portion of our Phase 2b/3 trial of AV-101 in PAH,” said Timothy Noyes, chief executive officer of Aerovate. “We are also pleased with investor confidence in Aerovate to support our IPO and provide sufficient capital which we believe will fund Aerovate into the second half of 2025.” Recent Events FDA Guidance Supports 6MWD as Primary Endpoint for Phase 3. At our April 14, 2021 end-of-Phase 1 meeting with the Food and Drug Administration (FDA), we received regulatory guidance that our Phase 2b/3 trial with AV-101 for the treatment of pulmonary arterial hypertension (PAH), if successful, could support a New Drug Application (NDA) submission using the change in six minute walk distance (6MWD) compared to placebo as the primary endpoint in the Phase 3 portion of the trial. Received Scientific Advice from EMA Regarding Requirements for Approval. We completed the formal process of seeking scientific advice and regulatory guidance from the European Medicines Agency (EMA) regarding its requirements for approval. We believe that, if successful, our existing clinical program could support a marketing authorization application submission for regulatory approval in Europe. Orphan Drug Designation Granted by FDA and EMA. We have obtained orphan drug designation from FDA for AV-101 for the treatment of PAH in the United States and received in May 2021 a positive opinion for orphan drug designation for AV-101 for the treatment of PAH from the EMA's Committee for Orphan Medicinal Products in the European Union. Raised $127.0 Million in Net Proceeds from IPO. On July 2, 2021, we closed our initial public offering (IPO) raising gross proceeds of $139.8 million, which included full exercise of the underwriters’ option to purchase additional shares of common stock, at a public offering pr...