Aerovate Therapeutics, Inc. - AVTE STOCK NEWS

Aerovate Therapeutics, a clinical-stage biopharmaceutical company, announced its participation at the Jefferies Global Healthcare Conference on June 9, 2022, at 3:30 p.m. ET. The presentation will cover AV-101 and its ongoing IMPAHCT Phase 2b/Phase 3 trial.

AV-101 is an investigational inhaled formulation of imatinib for pulmonary arterial hypertension (PAH). Initial Phase 1 results showed good tolerance among healthy volunteers. The IMPAHCT trial will evaluate AV-101's efficacy and safety in PAH patients. More details are available on Aerovate’s website.

Aerovate Therapeutics presented Phase 1 results for AV-101 at the ATS International Conference, indicating that the inhaled formulation of imatinib was well-tolerated by healthy adults. The study showed significant reduction in systemic exposure compared to oral imatinib, with common mild side effects like headaches and dizziness. AV-101 aims to treat pulmonary arterial hypertension (PAH) by directly targeting pulmonary vasculature and minimizing systemic toxicities. The company is advancing toward the Phase 2b/Phase 3 IMPAHCT trial, assessing the efficacy and safety of AV-101 in PAH patients.

Aerovate Therapeutics (AVTE) reported its Q1 2022 financial results, with cash and equivalents at $161.1 million as of March 31, compared to $167.4 million at year-end 2021. The net loss widened to $10.9 million from $2.8 million year-over-year, driven by increased R&D and G&A expenses. The company expects sufficient funding to support operations through H2 2025. Notably, the clinical trial for AV-101 is experiencing delays due to site staff shortages, with topline data now expected in late 2023 or early 2024.

Aerovate Therapeutics (AVTE) reported financial results for the year ended December 31, 2021, with a net loss of $23 million, up from $9.6 million in 2020. The company initiated the global IMPAHCT Phase 2b/Phase 3 trial for AV-101, a treatment for pulmonary arterial hypertension, in December 2021. They received FDA guidance indicating this trial could support a New Drug Application based on a primary endpoint of six-minute walk distance change. As of December 31, 2021, cash reserves totaled $167.4 million, expected to fund operations through mid-2025.

Aerovate Therapeutics (Nasdaq: AVTE) announced on March 2, 2022, that its management will present at the Cowen 42nd Annual Health Care Conference on March 8 at 10:30 a.m. ET. The presentation will cover AV-101 and the ongoing IMPAHCT Phase 2b/Phase 3 trial targeting pulmonary arterial hypertension (PAH). AV-101, a novel inhaled formulation of imatinib, aims to provide targeted treatment with fewer systemic side effects. The IMPAHCT trial evaluates AV-101's efficacy across different doses, assessing pulmonary vascular resistance and 6-minute walk distance over 24 weeks.

Aerovate Therapeutics has launched the IMPAHCT Phase 2b/Phase 3 trial to assess the efficacy and safety of AV-101 in adults with Pulmonary Arterial Hypertension (PAH). This study aims to identify the optimal AV-101 dose by comparing it against a placebo, focusing on changes in pulmonary vascular resistance (PVR) and 6-minute walk distance (6MWD). The company anticipates reporting top-line results from the Phase 2b segment by mid-2023, potentially offering significant advancements in treatment options for PAH patients.

Aerovate Therapeutics (Nasdaq: AVTE) reported its financial results for Q3 2021, highlighting significant progress in the Phase 2b/3 trial of AV-101 for pulmonary arterial hypertension (PAH). The company raised $126.9 million in net proceeds from its IPO, boosting cash reserves to $180.9 million. R&D expenses rose to $3.4 million, reflecting clinical trial costs, and G&A expenses increased to $2.8 million due to heightened operational activities. The net loss was $6.2 million, up from $2.3 million in Q3 2020. Financial guidance projects sufficient cash to sustain operations into H2 2025.

Aerovate Therapeutics (AVTE) has been added to the Russell 2000® Index following the annual reconstitution, effective after market close on September 17, 2021. CEO Timothy Noyes expressed optimism that this inclusion will enhance the company's visibility to investors. The firm is focused on developing AV-101, a dry powder inhaled formulation of imatinib, for pulmonary arterial hypertension (PAH), with plans to initiate Phase 2b trial enrollment this year. The Russell 2000 measures small-cap U.S. stocks and benchmarks approximately $10.6 trillion in assets.

Aerovate Therapeutics (Nasdaq: AVTE) reported its Q2 2021 financial results, showing significant growth and strategic advancements. The company received regulatory guidance from the FDA and EMA for its Phase 2b/3 trial of AV-101 for pulmonary arterial hypertension (PAH), positioning it for potential NDA submission. With a successful IPO raising $127 million in net proceeds, Aerovate's cash balance increased to $186.2 million. However, the company reported a net loss of $5.8 million for Q2 2021, up from $2.2 million in Q2 2020, driven by heightened R&D and G&A expenses.