Beyond Air Inc Stock Price, News & Analysis

Beyond Air (NASDAQ: XAIR) has submitted a PMA supplement to the FDA for LungFit PH II, their next-generation nitric oxide (NO) generator. The new system maintains the core functionality of the FDA-approved first generation while being smaller, lighter, and transport-ready. LungFit PH II uses the same Smart Filter and accessories, generating NO from ambient air using patented Ionizer technology. The system delivers NO doses from 0.5-80 ppm for treating PPHN, requiring only the power equivalent to a 60-watt bulb. Key improvements include reduced weight and footprint, simplified operation, longer service intervals, transport compatibility, and an automated backup system. The device aims to treat conditions like PPHN, which affects 1.9 per 1,000 live births with 4-33% mortality rate.

Beyond Air (NASDAQ: XAIR), a commercial-stage medical device and biopharmaceutical company specializing in nitric oxide (NO) treatments, has announced its upcoming fiscal year 2025 financial results conference call. The company will report its fiscal fourth quarter and full year results ended March 31, 2025 on Tuesday, June 17, 2025.

The management team will host a conference call and webcast at 4:30 PM Eastern Time. Investors can access the call through domestic (1-877-407-0784) or international (1-201-689-8560) lines using conference ID 13753945. A webcast will be available through the company's website, with a replay accessible one hour after the call.

Beyond Air (NASDAQ: XAIR) has secured U.S. Patent No. 12,274,830 from the USPTO for its method of treating non-tuberculous mycobacteria (NTM) lung infections using gaseous nitric oxide (gNO). The patent covers a specific dosing regimen of 200-320 ppm gNO for 10-45 minutes, 2-5 times daily, delivering 300-900 ppm-hrs of gNO per day over at least 14 days. The patent protection extends until March 12, 2038.

The company recently reported positive clinical data in the American Thoracic Society Journal demonstrating LungFit GO's potential for safe and effective at-home treatment of NTM infections. NTM is a rare but serious bacterial lung infection affecting approximately 13% of U.S. cystic fibrosis patients as of 2017. Current treatments involve lengthy antibiotic combinations with poor efficacy and potential severe side effects.

NeuroNOS, a subsidiary of Beyond Air (NASDAQ: XAIR), has received FDA Orphan Drug Designation for BA-102, its lead investigational therapy targeting Phelan-McDermid Syndrome (PMS), a rare genetic disorder associated with Autism Spectrum Disorder (ASD).

PMS is caused by SHANK3 gene deletions or mutations, resulting in developmental delays, intellectual disability, and severe speech impairments. Currently, no FDA-approved treatments exist specifically for PMS. The company plans to initiate first-in-human clinical trials for ASD in the United States in 2026.

The Orphan Drug Designation provides significant benefits including:

• Seven years of market exclusivity upon approval
• Tax credits for qualified clinical trials
• FDA application fee waivers
• Access to FDA protocol assistance

NeuroNOS, a Beyond Air (NASDAQ: XAIR) subsidiary, has appointed Nobel Prize laureate Professor Dan Shechtman to its Scientific Advisory Board. Shechtman, who won the 2011 Nobel Prize in Chemistry for discovering quasicrystals, joins fellow Nobel laureate Professor Roger Kornberg in advancing treatments for Autism Spectrum Disorder (ASD) and Alzheimer's Disease (AD).

The company's proprietary platform combines behavioral techniques, AI, and wet lab capabilities to develop neurological disorder treatments. NeuroNOS is currently conducting preclinical studies to support an FDA IND application, with plans to begin first-in-human clinical trials for ASD in 2026. Their lead drug candidate, BA-102, is advancing through preclinical development.

Professor Shechtman, currently a Distinguished Professor at the Technion, brings expertise in materials science, structural chemistry, and innovation to strengthen the company's scientific capabilities.

Beyond Air (NASDAQ: XAIR) has published promising results from its pilot study of the LungFit™ GO device for treating Nontuberculous Mycobacterial (NTM) pulmonary disease in the Annals of the American Thoracic Society journal.

The 12-week multi-center trial, supported by the U.S. Cystic Fibrosis Foundation, enrolled 15 patients with chronic refractory NTM lung disease. Patients successfully self-administered high-dose nitric oxide (NO) treatments at home with over 90% compliance rate. The study demonstrated that patients could safely self-administer up to 250 ppm NO treatments with no serious adverse events or treatment discontinuations.

Key findings include:

• High compliance with over 2,400 self-administered inhalations
• Meaningful improvements in quality of life domains
• Maintained respiratory and physical function
• Trends showing reduction in microbial load
• One subject achieved culture conversion during follow-up

NeuroNOS, a subsidiary of Beyond Air (NASDAQ: XAIR), announces groundbreaking research publication in Translational Psychiatry demonstrating a novel mechanism in early-stage Alzheimer's disease (AD). The study, led by CSO Prof. Haitham Amal, identifies significant disruptions in nitric oxide (NO)-related pathways and S-nitrosylation across two AD mouse models.

The research reveals the role of nitrosative stress, impaired neurotransmission, and mTOR hyperactivation, suggesting that targeted inhibition of NO production could be a promising therapeutic strategy. The company has filed five patent families and is preparing for clinical trials, with plans to initiate first-in-human autism trials in the US in 2026.

NeuroNOS's platform focuses on treating complex neurological disorders including autism, Alzheimer's, and brain cancers. The company has discovered a common link between autism and AD involving the neuronal nitric oxide synthase (nNOS) enzyme, supporting their strategy of targeting NO pathways across multiple neurological conditions.

Beyond Air (NASDAQ: XAIR) has announced Vanderbilt University Medical Center (VUMC) as its first luminary site, marking a significant milestone in the company's mission to advance tankless nitric oxide delivery technology. LungFit PH, their innovative device, generates nitric oxide from room air without requiring traditional high-pressure cylinders.

Craig Rooks, Sr. Director of Respiratory Care at VUMC, highlighted how the device enhances workflow efficiency in ICU settings and enables anesthesiologists to manage it directly in operating rooms. This implementation is particularly important as VUMC prepares to expand its heart and lung transplant programs following a record year of heart transplants in 2024.

The collaboration aims to showcase the technology's benefits to potential customer hospitals, with VUMC serving as a demonstration site for respiratory therapists, anesthesiologists, and medical directors considering the cylinder-free, iNO delivery system.

NeuroNOS, a subsidiary of Beyond Air (NASDAQ: XAIR), has secured $2 million in equity financing from private investors to advance its innovative autism therapy development. The funding will accelerate preclinical development of a small-molecule drug designed for injectable and oral treatment of children with autism.

The therapy, based on research by Prof. Haitham Amal at Hebrew University of Jerusalem, targets nitric oxide (NO) regulation in the brain. The research demonstrated elevated NO levels in children with ASD, and inhibiting NO production reversed autism-like phenotypes in multiple models. The findings have been validated in over 700 animals, human stem cell-derived neurons, and blood samples from children with autism.

NeuroNOS has partnered with a U.S.-based contract manufacturer and is in advanced stages of formulation development, initially focusing on subcutaneous injection with plans for an oral formulation. First-in-human studies are anticipated to begin in 2026.