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Aerovate Therapeutics Announces First Quarter 2022 Financial Results
WALTHAM, Mass., May 16, 2022 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical stage biopharmaceutical company focused on developing
About this update from Jade Biosciences, Inc.
[{"type":"text","content":"WALTHAM, Mass., May 16, 2022 (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 financial results for the quarter ended March 31, 2022, and recent business highlights. Recent Highlights Reiterating strong financial position funding operations into the second half of 2025Updating guidance and expect to report topline data from the Phase 2b portion of the IMPAHCT trial in the fourth quarter of 2023 or first quarter of 2024Strengthened and expanded management team by hiring Marco Verwijs as SVP, CMC and Susan Fischer as SVP, Development Operations Update on IMPAHCT Global Phase 2b/Phase 3 Clinical Trial. IMPAHCT (Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial) is a Phase 2b/Phase 3 trial of AV-101, our dry powder inhaled formulation of the anti-proliferative drug imatinib for the treatment of pulmonary arterial hypertension (PAH), a devastating disease impacting approximately 70,000 people in the United States and Europe. With IMPAHCT now active at multiple sites, investigators and key opinion leaders continue to express enthusiasm for our Phase 2b/Phase 3 trial. However, we are experiencing site initiation delays as a result of clinical trial site staff shortages and COVID-related short-term interruptions. Because of these delays, we expect to report topline data from the Phase 2b portion of the trial in the fourth quarter of 2023 or first quarter of 2024. We have obtained orphan drug designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for AV-101 for the treatment of PAH in the United States and the European Union. Expanded Intellectual Property Portfolio. We continued expanding our intellectual property portfolio with the issuance of Patent 11,298,355 and two additional allowances from the United States Patent and Trademark Office. Management Team Strengthened. We hired Marco Verwijs as SVP, CMC and Susan Fischer as SVP, Development Operations. Mr. Verwijs has over 15 years of product development and manufacturing experience. He has worked on multiple commercial products, leading them from clinical product development to New Drug Application filing and commercial launch. Ms. Fischer ha...