This section highlights FDA-related milestones and regulatory updates for drugs developed by Beyond Air (XAIR).
Over the past two years, Beyond Air has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BA-102 and LungFit. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
BA-102 - FDA Regulatory Timeline and Events
BA-102 is a drug developed by Beyond Air for the following indication: For the treatment of Phelan-McDermid Syndrome (PMS).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BA-102
- Announced Date:
- April 21, 2025
- Indication:
- For the treatment of Phelan-McDermid Syndrome (PMS)
Announcement
NeuroNOS a subsidiary of Beyond Air announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead investigational therapy, BA-102, for the treatment of Phelan-McDermid Syndrome (PMS), a syndrome associated with Autism Spectrum Disorder (ASD).
AI Summary
NeuroNOS, a subsidiary of Beyond Air, recently received Orphan Drug Designation from the FDA for its investigational therapy BA-102. This key designation is for the treatment of Phelan-McDermid Syndrome (PMS), a rare genetic disorder closely linked with Autism Spectrum Disorder. PMS is usually caused by deletions or mutations impacting the SHANK3 gene, leading to global developmental delays, intellectual disabilities, speech impairments, and other autism-related behaviors.
The designation gives NeuroNOS important benefits, such as market exclusivity for seven years after approval, tax credits for clinical trials, fee waivers, and access to FDA protocol assistance. The company plans to begin first-in-human U.S. clinical trials for this therapy in 2026, marking a significant step toward developing a targeted treatment that could improve the lives of patients and families affected by PMS.
Read Announcement- Drug:
- BA-102
- Announced Date:
- April 21, 2025
- Indication:
- For the treatment of Phelan-McDermid Syndrome (PMS)
Announcement
NeuroNOS, a subsidiary of Beyond Air announced that Plan to initiate first-in-human U.S. clinical trials of lead drug candidate for treating ASD in 2026
AI Summary
NeuroNOS, a subsidiary of Beyond Air, announced plans to begin first-in-human clinical trials in the United States in 2026. The trials will evaluate BA-102, its lead drug candidate aimed at treating Autism Spectrum Disorder (ASD). BA-102 is designed for patients with Phelan-McDermid Syndrome (PMS), a rare neurodevelopmental disorder that is often linked to ASD. PMS usually occurs due to deletions or mutations in the SHANK3 gene and can cause developmental delays, intellectual disabilities, and severe speech impairments. By focusing on the genetic basis of the condition, NeuroNOS aims to offer new treatment options for people who currently have few alternatives. The planned clinical trials mark an important milestone in the company’s efforts to advance targeted therapies for ASD and related neurodevelopmental disorders.
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LungFit PH - FDA Regulatory Timeline and Events
LungFit PH is a drug developed by Beyond Air for the following indication: Persistent pulmonary hypertension of the newborn (PPHN).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LungFit PH
- Announced Date:
- January 24, 2025
- Indication:
- Persistent pulmonary hypertension of the newborn (PPHN)
Announcement
Beyond Air, Inc. announced that the LungFit® PH has received market authorization from the Australian Therapeutic Goods Administration (TGA) for sale as a Class IIb medical device to deliver nitric oxide, a vasodilator, generated by the device into the inspiratory limb of the patient breathing circuit of a ventilator in a way that provides a constant concentration of nitric oxide, as set by the user, to the patient throughout the inspired breath.
AI Summary
Beyond Air, Inc. announced that its LungFit® PH device has been approved by the Australian Therapeutic Goods Administration (TGA) as a Class IIb medical device. This device is designed to deliver a steady and controlled amount of nitric oxide—a substance that helps widen blood vessels—to ventilated patients. The LungFit® PH works by generating nitric oxide from the surrounding air and ensures that the user-set concentration is maintained throughout each breath.
The approval paves the way for the device’s use in Australian hospitals, with shipments scheduled to begin in the coming months via Getz Healthcare. This latest clearance complements recent approvals in the United States and the European Union, marking a significant step in expanding the global use of LungFit® PH to provide critical respiratory care in a sustainable and efficient way.
Read Announcement
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