Beyond Air, Inc. XAIR
Beyond Air, Inc. (Nasdaq: XAIR) is a respiratory medical device company. Its next catalyst on record is LungFit GO (NTM): Discussions with FDA to identify a path forward (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: LungFit GO (NTM) — Discussions with FDA to identify a path forward (2026). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| UNO (ultra-high concentration NO) via Beyond Cancer | solid tumors | device-combination | Phase 1 |
| BA-102 / BA-101 nNOS inhibitors via NeuroNOS | Phelan-McDermid syndrome / autism; glioblastoma | small molecule | Pre-clinical |
| LungFit PH (first generation, PMA approved June 2022) | PPHN | device-combination | NA_NON_THERAPEUTIC |
| LungFit PH II (PMA supplement submitted June 2025) | PPHN / cardiac surgery label expansion, transport-ready device | device-combination | NA_NON_THERAPEUTIC |
| LungFit GO (high-dose NO) | nontuberculous mycobacteria (NTM) lung infection | device-combination | NA_NON_THERAPEUTIC |
| LungFit PRO (high-dose NO) | viral community-acquired pneumonia; bronchiolitis | device-combination | NA_NON_THERAPEUTIC |
Recent results and decisions
- Nov 14, 2025submitted PMA supplement for second-generation LungFit PH submitted to FDA June 2025; approval and launch anticipated before end of calendar 2026.
PMA supplement for the second-generation LungFit PH submitted to U.S. FDA in June 2025.
Filing - Nov 10, 2025positive Phase 1a Part A (n=10) completed; median OS not yet reached, expected to exceed 23 months.
Latest results to date from the Phase 1a trial show median overall survival (mOS) has not yet been achieved, with median survival expected to exceed 23 months.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
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- Full catalyst list with filing sentences, deals, registered trials, Excel export
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.