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. (symbol: XAIR) is a clinical-stage medical device and biopharmaceutical company focused on revolutionizing respiratory disease treatments through innovative technology. The company's flagship product is the LungFit™ system, a Nitric Oxide (NO) Generator and Delivery System that uses NO generated from ambient air to deliver precise amounts of NO to the lungs of both ventilated and non-ventilated patients. This breakthrough technology is aimed at treating various pulmonary diseases, including pulmonary hypertension, severe lung infections such as SARS-CoV-2, and nontuberculous mycobacteria (NTM).
LungFit™ can generate up to 400 ppm of NO, offering flexibility in delivery either continuously or for a fixed period. It also features the ability to titrate the dose on demand or maintain a constant dose. This system is currently advancing in clinical trials and has garnered attention for its potential in treating lower respiratory tract infections that are not effectively addressed by current standards of care.
Beyond Air is also exploring ultra-high concentrations of NO with a proprietary delivery system separate from LungFit™ to target certain solid tumors. This preclinical testing aims to offer new hope for cancer treatments, making Beyond Air a pioneer in utilizing NO for diverse therapeutic applications.
Notably, Beyond Air has achieved significant milestones, including FDA approval for its LungFit® PH system designed for treating term and near-term neonates with hypoxic respiratory failure. The company has partnered with The Hebrew University of Jerusalem to develop treatments for neurological disorders like autism spectrum disorder (ASD). In addition, Beyond Cancer, Ltd., an affiliate of Beyond Air, is investigating ultra-high concentrations of NO to target specific solid tumors.
Financially, Beyond Air has shown a commitment to growth, as evidenced by its recent increase in general and administrative expenses, primarily driven by stock-based compensation and professional fees. The company maintains a forward-looking stance, aiming to expand its product portfolio and enhance its market position.
For more detailed information on their latest developments and product offerings, visit Beyond Air's official website.
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.
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