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 commercial-stage medical device and biopharmaceutical company centered on nitric oxide (NO) technologies, and its news flow reflects both commercial execution and clinical development. Company announcements frequently highlight progress with the LungFit PH system, a cylinder-free NO generator and delivery device approved for treating term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension. Investors can follow updates on U.S. hospital adoption, international distribution agreements, regulatory milestones, and quality certifications related to this platform.
News items also cover Beyond Air’s broader LungFit pipeline, including clinical trials evaluating higher-concentration NO for severe lung infections such as viral community-acquired pneumonia and nontuberculous mycobacteria. These stories often discuss regulatory submissions, design patents for next-generation devices, and participation in medical and industry conferences.
On the biopharmaceutical side, Beyond Air and its affiliates generate news about oncology and neurology programs. Beyond Cancer, Ltd. reports early-stage clinical data and preclinical work using ultra-high concentration NO for solid tumors, while NeuroNOS communications describe small-molecule nNOS inhibitors, preclinical findings in Autism Spectrum Disorder and brain cancers, and U.S. FDA Orphan Drug Designations for glioblastoma and Phelan-McDermid Syndrome. Transactions such as the agreement for XTL Biopharmaceuticals to acquire a majority stake in NeuroNOS are also covered.
Capital markets and corporate governance updates are another recurring theme, including private placements, warrant exercises, promissory notes, equity purchase agreements, reverse stock splits, and leadership changes. For investors and analysts tracking XAIR, this news page provides a centralized view of commercial rollouts, clinical milestones, financing activity, and strategic partnerships that shape the company’s nitric oxide-focused portfolio.
Beyond Air (NASDAQ: XAIR) announced a delay in the U.S. commercial launch of LungFit® PH for persistent pulmonary hypertension of the newborn (PPHN), which will not occur before December 31, 2021. The company anticipates receiving CE Mark approval in Europe for LungFit® PH within the first half of 2022. Beyond Air is committed to advancing its nitric oxide delivery system for treating serious respiratory conditions and solid tumors, showcasing its dedication to regulatory collaboration and innovation in pediatric care.
Beyond Air (NASDAQ: XAIR) has appointed Dr. Andrew Colin as Chief Medical Officer effective December 1, 2021. Dr. Colin, with four decades in pediatric pulmonology, has been a key member of Beyond Air’s Scientific Advisory Board since 2013. His extensive experience includes over 20 clinical trials and contributions to various pulmonology advancements. The company is focused on developing inhaled nitric oxide therapies for respiratory conditions and solid tumors. The leadership change is expected to enhance the growth of clinical programs, particularly in acute viral infections and nontuberculous mycobacteria.
Beyond Air has secured $30 million in a private placement of common shares for its affiliate, Beyond Cancer, giving investors a 20% equity stake. This funding will be utilized to accelerate preclinical studies, hire additional team members, and optimize the delivery system for nitric oxide treatments. Beyond Air retains 80% equity ownership in Beyond Cancer. The transaction, expected to close this quarter, aligns with Beyond Air's goal to develop inhaled nitric oxide therapies for pulmonary and cancer-related conditions. The shares are being offered under exemption from registration requirements.
Beyond Air (NASDAQ: XAIR) announced that the U.S. FDA is reviewing its premarket approval submission for LungFit® PH to treat persistent pulmonary hypertension in newborns, aiming for a commercial launch in Q4 2021. The company raised $23.9 million to establish Beyond Cancer, an entity targeting ultra-high concentration nitric oxide for solid tumors. Positive interim results from the LungFit® GO pilot study for NTM lung infections were reported, with full data expected in 2022. Financially, the company reported zero revenue in Q1 2021, with a net loss of $8.7 million.
Beyond Air announces a $23.9 million equity private placement to establish Beyond Cancer, a new entity to advance its solid tumor pipeline with a focus on ultra-high concentration nitric oxide (UNO).
Led by Selena Chaisson, M.D., Beyond Cancer aims to leverage Beyond Air's expertise and intellectual property to develop new oncology treatments. Beyond Air will maintain 80% ownership and receive royalties on future revenues, allowing it to concentrate on its LungFit platform for respiratory diseases.
Beyond Air, Inc. (NASDAQ: XAIR) announced participation in the Piper Sandler 33rd Annual Virtual Healthcare Conference from November 30 to December 2, 2021. CEO Steve Lisi will provide a pre-recorded investor presentation and engage in virtual one-on-one meetings. The presentation will be accessible to registered attendees from November 22 to December 2, 2021. Beyond Air focuses on developing inhaled nitric oxide for respiratory conditions and solid tumors, utilizing its innovative LungFit® system.
Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage company, will announce its fiscal Q2 2021 results on November 11, 2021, at 4:30 PM ET. The conference call will provide insights into the financial performance and progress of its inhaled nitric oxide therapies for respiratory conditions and solid tumors. Beyond Air is focused on developing its LungFit® system, aiming to treat severe lung infections and pulmonary hypertension. For more information, please visit www.beyondair.net.
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.