Business
Aerovate Therapeutics Announces Full-Year 2021 Financial Results
Initiated IMPAHCT, a global Phase 2b/Phase 3 trial of AV-101 for pulmonary arterial hypertension (PAH) in December 2021Received FDA guidance in April 2021
About this update from Jade Biosciences, Inc.
[{"type":"text","content":"Initiated IMPAHCT, a global Phase 2b/Phase 3 trial of AV-101 for pulmonary arterial hypertension (PAH) in December 2021Received FDA guidance in April 2021 that our Phase 2b/Phase 3 trial could support an NDA submission based on change in six minute walk distance as the primary endpoint for the Phase 3 portion of the trialGranted orphan drug designation by the FDA in December 2020 and EMA for AV-101 for the treatment of PAH in June 2021Raised $126.9 million in net proceeds from IPO in July 2021 WALTHAM, Mass., March 30, 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 year ended December 31, 2021, and recent business highlights. “We’ve built a team with deep experience in pulmonary arterial hypertension and pulmonary drug development,” said Timothy Noyes, chief executive officer of Aerovate. “We were excited to initiate our global Phase 2b/Phase 3 trial of AV-101 in PAH last December and are well-positioned to execute our plan. Aerovate was founded to develop AV-101 for PAH and our team is excited to work closely with clinicians, KOLs, clinical sites, and patient groups.” 2021 Highlights Progress Continues for 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 PAH, a devastating disease impacting approximately 70,000 people in the United States and Europe. Along with initiating the trial, drug supply has been manufactured and we have been shipping it to clinical sites. We anticipate including experienced PAH centers from more than 20 countries in our Phase 2b/Phase 3 trial. 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. FDA Guidance Supports 6MWD as Primary Endpoint for Phase 3. At our April 14, 2021 End-of-Phase 1 meeting with the FDA, we received regulatory guidance that our Phase 2b/Phase 3 trial with AV-101 for the treatment of PAH, if successful, cou...