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) announced positive interim results from the LungFit® GO pilot study in Australia, focusing on self-administered high-concentration inhaled nitric oxide (NO) therapy for severe nontuberculous mycobacterial lung disease. At the data cutoff on September 6, 2021, eight subjects were safely titrated to 250 ppm NO without serious adverse events. The device is aimed at providing patients the freedom to self-administer treatment at home. Complete safety and efficacy results are expected in 2022.
Beyond Air, Inc. (NASDAQ: XAIR) has announced progress in its regulatory approval process for the LungFit® PH system. The Stage 1 Assessment Audit for European CE Mark approval has been completed, with expectations to receive the CE Mark in the first half of 2022. Concurrently, FDA inspections for US commercial launch remain ongoing, targeting a launch in Q4 2021 for treating persistent pulmonary hypertension of the newborn. LungFit® utilizes inhaled nitric oxide for respiratory conditions, aiming to transform treatment methodologies in hospitals and home settings.
Beyond Air, Inc. (NASDAQ: XAIR) announced that Steve Lisi, Chairman and CEO, will present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit from September 20-23, 2021. His presentation is scheduled for September 22, 2021, at 9:05 AM ET. Beyond Air specializes in developing inhaled nitric oxide for respiratory conditions and gaseous NO for solid tumors. The LungFit® system allows precise NO delivery for various pulmonary diseases. For more information, visit beyondair.net.
Beyond Air, Inc. (NASDAQ: XAIR) announced the appointment of Douglas Larson as Chief Financial Officer, effective September 1, 2021, succeeding Douglas Beck, who will act as a consultant post-transition.
Larson brings over 20 years of international finance experience, previously serving at DBV Technologies and The Scotts Miracle-Gro Company. The company granted Larson an inducement stock option for 75,000 shares, exercisable at the last sale price on September 1, 2021. This strategic leadership change is positioned to guide Beyond Air as it transitions towards commercialization.
Beyond Air, Inc. (NASDAQ: XAIR) announced key updates, including ongoing FDA review for the LungFit® PH system to treat persistent pulmonary hypertension of the newborn (PPHN), with commercial launch expected in Q4 2021. Financial results for Q1 2021 showed revenue of $0, dropping from $229,000 in Q1 2020. R&D expenses decreased to $2.7 million, while general and administrative expenses rose to $3.9 million. The net loss for the quarter remained stable at $6.7 million but improved per share to ($0.31). The company holds $39.6 million in cash as of June 30, 2021, indicating a solid financial position.
Beyond Air (NASDAQ: XAIR) will report its financial results for the first fiscal quarter ended June 30, 2021, on August 10, 2021, during a conference call at 4:30 PM ET. The company focuses on developing inhaled nitric oxide treatments for respiratory conditions and solid tumors. Their innovative LungFit® system delivers precise doses of nitric oxide generated from ambient air. Upcoming financial disclosures will provide insights into the company's progress in clinical trials aimed at addressing serious lung infections and other pulmonary diseases.
Beyond Air, Inc. (NASDAQ: XAIR) is a clinical-stage company focusing on inhaled nitric oxide therapies for respiratory conditions. CEO Steve Lisi will attend two virtual investor conferences in July 2021: the Ladenburg Thalmann Annual Healthcare Conference from July 13-14 and the William Blair Biotech Focus Conference from July 14-15. Management will engage in a fireside chat and available for one-on-one meetings during these events. The company is advancing its LungFit® system for treating severe respiratory infections and solid tumors.
Beyond Air submitted its first PMA application to the FDA for LungFit® PH to treat persistent pulmonary hypertension of the newborn, aiming for a commercial launch in Q4 2021. The company appointed industry veterans to its commercial team and presented positive data for high-concentration nitric oxide in patients with viral lung infections. Financially, it reported $873K in revenue for FY 2021, down from $1.4M in FY 2020, with a net loss of $22.9M or ($1.27) per share. Upcoming milestones include expected FDA approval for LungFit® PH by late Q3 2021.
Beyond Air (NASDAQ: XAIR) has secured full global rights to LungFit® PH after reaching an agreement with Circassia Group. The deal involves repaying $10.5 million in upfront payments over two years, post-FDA approval, with future royalties capped at $6 million. LungFit® PH aims to be the first product using ambient air to generate nitric oxide for treating pulmonary conditions. The company anticipates a US launch later this year, with CE Mark expected in the EU. As of April 30, 2021, Beyond Air reported $34.9 million in cash and a quarterly spend of $5 million.
Beyond Air, Inc. (NASDAQ: XAIR) has announced its upcoming financial results for the fourth fiscal quarter and the year ending March 31, 2021, set to be reported on June 10, 2021. A conference call will follow at 4:30 PM ET, allowing the management to discuss outcomes and expectations regarding their innovative LungFit® device, designed for the delivery of nitric oxide to treat various respiratory conditions and solid tumors. The company is advancing its clinical trials targeting severe lung infections and pulmonary hypertension.
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