Belgium's Nyxoah falls on delayed launch of sleep apnea device

U.S.-listed shares of Belgian medical device maker Nyxoah NYXH.BR, NYXH.O fall ~15% to $9.63

Co says U.S. FDA has issued an "Approvable Letter" for Genio system to treat moderate to severe sleep apnea

Obstructive sleep apnea patients stop breathing briefly while sleeping

FDA issues approvable letters when it classifies a device as approved, pending information such as review of manufacturing

Piper Sandler analyst Adam Maeder says the update "derisks" U.S. regulatory approval process

Says approval and launch expected to be delayed by about 1-2 quarters, but revenue impact to be "negligible in the bigger picture"

Co was expecting approval by the end of 1Q25

NYXH fell 16.4% in the last 12 months