Welcome to our dedicated page for Beyond Air news (Ticker: XAIR), a resource for investors and traders seeking the latest updates and insights on Beyond Air stock.
Beyond Air Inc (NASDAQ: XAIR) is a clinical-stage medical technology company pioneering nitric oxide delivery systems for respiratory care. This news hub provides investors and healthcare professionals with essential updates on regulatory milestones, clinical trial progress, and technological advancements related to the LungFit™ platform.
Access timely press releases covering FDA communications, partnership announcements, and research developments in pulmonary hypertension treatment. Our curated collection includes updates on international regulatory strategies and peer-reviewed study publications, offering critical insights into the company's position within the respiratory therapy market.
Key content categories include clinical trial results, device approval updates, executive leadership changes, and scientific conference presentations. This resource enables stakeholders to track the company's progress in developing NO-based solutions for ventilator-associated pneumonia and chronic lung conditions.
Bookmark this page for streamlined access to material developments affecting XAIR's market position. For comprehensive analysis of how these updates may influence investment decisions, consult your financial advisor and review official SEC filings.
Beyond Air, Inc. (NASDAQ: XAIR) has secured up to $2.17 million from the Cystic Fibrosis Foundation to advance its LungFit™ GO pilot study targeting Nontuberculous Mycobacteria (NTM) pulmonary disease. This 12-week trial in Australia aims to enroll around 20 patients suffering from refractory mycobacterial lung infections. Interim data is expected mid-2021, with topline results anticipated six months later. The funding will support the self-administration of high concentration nitric oxide (NO) for improved treatment outcomes, particularly for cystic fibrosis patients.
Beyond Air (NASDAQ: XAIR) announced its FDA is reviewing the premarket approval (PMA) for LungFitTM PH to treat persistent pulmonary hypertension of the newborn (PPHN), potentially launching this summer. The company reported a revenue of $149,000 for Q3 2020, down from $314,000 in Q3 2019, with a net loss of $5.8 million, or ($0.33) per share. Their ongoing studies include acute viral pneumonia and Nontuberculous Mycobacteria treatments. Cash reserves stand at $22.7 million as of December 31, 2020. A conference call is scheduled for February 9th at 4:30 PM ET.
Beyond Air, Inc. (NASDAQ: XAIR) announces its financial results for the third fiscal quarter ending December 31, 2020. The report is scheduled for February 9, 2021, with a dedicated conference call at 4:30 PM ET. The company focuses on developing inhaled nitric oxide for various respiratory conditions and solid tumors, aiming to improve treatment options for severe lung infections like SARS-CoV-2. Beyond Air's innovative LungFit™ system delivers precise amounts of nitric oxide, targeting pulmonary diseases and advancing in clinical trials.
Beyond Air (NASDAQ: XAIR) has initiated a pilot clinical trial for its LungFit™ GO device targeting nontuberculous mycobacteria (NTM) lung disease, expected to enroll 20 adult patients in Australia. The 12-week, open-label study will first dose patients in January 2021 and report interim findings mid-2021. LungFit™ GO aims to provide at-home treatment options for patients with chronic respiratory conditions, potentially improving quality of life and outcomes for those with severe lung infections.
Beyond Air, Inc. (NASDAQ: XAIR) announced that Steve Lisi, its CEO, will participate in the 32nd Annual Piper Sandler Healthcare Conference virtually from December 1-3, 2020. The company will provide a pre-recorded investor presentation and engage in virtual one-on-one meetings.
Beyond Air is focused on developing inhaled nitric oxide (NO) therapies for respiratory conditions, including severe infections and pulmonary hypertension. Its LungFit™ device generates NO from ambient air, potentially treating various pulmonary diseases.
Beyond Air submitted a premarket approval (PMA) to the FDA for LungFit™ PH, targeting persistent pulmonary hypertension of the newborn (PPHN). Enrollment for an acute viral pneumonia study is set to begin next week. The company reported $350,000 in revenue for Q2 2020, down from $646,000 in Q2 2019, and a net loss of $5.1 million or ($0.30) per share. Cash reserves stand at $22.4 million. Upcoming milestones include potential FDA approval for LungFit™ PH and initiation of a pilot study for nontuberculous mycobacteria lung infection.
Beyond Air, Inc. (NASDAQ: XAIR) has submitted a premarket approval (PMA) application to the FDA for its LungFit™ PH device, aimed at treating persistent pulmonary hypertension of the newborn (PPHN). The PMA review will take 180 days, with a potential launch in Q2 2021 pending approval. This device generates nitric oxide from ambient air, eliminating the need for traditional gas cylinders, thereby enhancing safety and operational efficiency in hospitals. PPHN affects approximately 1.9 per 1000 live births and can have serious health consequences for newborns.
Beyond Air, Inc. (NASDAQ: XAIR) will report its financial results for the second fiscal quarter ended September 30, 2020, on November 11, 2020, followed by a conference call at 4:30 PM ET. The company focuses on developing inhaled nitric oxide for respiratory conditions and gaseous NO for treating tumors. Its product, LungFit™, can deliver precise NO dosage continuously or at fixed intervals, with ongoing clinical trials targeting severe lung infections, including SARS-CoV-2. For more information, visit www.beyondair.net.
Beyond Air, Inc. (NASDAQ: XAIR) announced plans to initiate a clinical study to evaluate the safety and efficacy of the LungFit™ system using inhaled Nitric Oxide (NO) for hospitalized adults with acute viral pneumonia, including SARS-CoV-2 infections. The multi-center trial in Israel aims to enroll 90 patients, comparing NO treatment combined with standard supportive care against supportive care alone. The LungFit™ system generates NO from ambient air, providing potential advantages in treating respiratory conditions.
Beyond Air (NASDAQ: XAIR) announced promising preclinical data indicating that high concentrations of gaseous nitric oxide (gNO) administered directly to solid tumors may induce a systemic anti-tumor immune response. Key findings from studies on colon and breast cancer-bearing mice indicated that 100% of naïve mice had tumor uptake, whereas 27% and 0% of treated mice showed uptake, suggesting a dose-dependent effect. The company aims to further explore gNO's clinical potential, with a first in human study anticipated. This innovative approach could represent a significant shift in cancer treatment.
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