Apnimed's OSA drug NDA accepted by FDA, PDUFA date set for February 2027
Apnimed reported second-quarter 2026 results alongside FDA acceptance of the NDA for AD109, proposed name Oxnimbi, and completion of its upsized IPO.
SEC filing
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Friday, September 11
Tuesday, September 8
Wednesday, August 12
Apnimed posts Phase 2 MARIPOSA results showing AD109 cut AHI4 versus placebo
Friday, July 31
Apnimed prices IPO at $16 per share ahead of Nasdaq debut
The company is offering 12 million shares as its lead sleep apnea drug candidate awaits FDA decision by February 28, 2027.
SEC filing
Friday, July 10
Apnimed files for IPO as FDA reviews Oxnimbi NDA for sleep apnea
The company disclosed FDA feedback questioning whether its Phase 3 data show a clinically meaningful benefit, even as it seeks Nasdaq listing under "APMD."
SEC filing