Apnimed Inc.’s lead oral therapy for obstructive sleep apnea has delivered a second round of positive phase III data, bringing a potential U.S. FDA filing closer. Top-line results taken from the second pivotal late-stage study show AD-109 (aroxybutynin 2.5mg/atomoxetine 75 mg) hit its primary endpoint with clinically meaningful and statistically significant drops in airway obstruction at 26 weeks.
Mosanna Therapeutics secured $80 million in a series A round to develop MOS-118 as a treatment for the nearly 1 billion people globally with obstructive sleep apnea (OSA). The company has completed the formulation work to make the drug into a nasal spray and the initial proof-of-concept animal studies and is now ready to enter clinical trials in patients with OSA.
Mirroring results reported in a phase IIb study, Apnimed Inc.’s first of two pivotal trials testing AD-109 as an oral therapy in obstructive sleep apnea hit primary and secondary endpoints. Should similar findings emerge from a second phase III trial, expected to read out in a couple of months, the privately held firm anticipates a U.S. NDA filing in early 2026.
To increase diagnosis across Australia, the partnership will see Compumedics Ltd. of Melbourne supply its Somfit devices and electrodes to Philips’ pharmacy-based sleep programs in pharmacies across Australia.
As Wall Street looks ahead to phase III data due soon with Mineralys Therapeutics Inc.’s lorundrostat for uncontrolled or resistant hypertension, analysts are also weighing the odds of the firm in phase II with the same compound for obstructive sleep apnea.
One potentially serious complication of obstructive sleep apnea (OSA) is pulmonary hypertension (PH). Based on previous research that revealed involvement of perivascular immune and inflammatory responses in regulation of vascular remodeling and PH processing, researchers from Fudan University investigated the immunologic factors linked to OSA-induced PH.
Kyorin Pharmaceutical Co. Ltd. has acquired Bayer AG’s phase II obstructive sleep apnea candidate, BAY-2925976, in a deal worth €85M (US$89.3 million) plus sales-based royalties and commercial milestones.
Nyxoah SA recently raised $27 million after selling three million shares in a bid to shore up its capital base as it prepares to commercialize Genio — its obstructive sleep apnea technology — in the U.S.
In obstructive sleep apnea (OSA), the collapse of the upper airway at sleep onset leads to a decrease in blood oxygen levels, frequent arousals from sleep and consequently fatigue and daytime sleepiness.
