Apnimed Prepares FDA Filing for Sleep Apnea Pill

Apnimed, a Cambridge, Massachusetts-based company valued at $400 million, is preparing to file for FDA approval of a nightly pill for obstructive sleep apnea. The medication combines two existing drugs and is intended to keep throat muscles from relaxing fully during sleep while allowing the brain to rest.

The company acquired rights to the treatment from Harvard researchers who first observed its effects in 2016. Dr. Luigi Taranto Montemurro, now Apnimed's chief scientific officer, tested the drug combination on a patient at Brigham and Women's Hospital and noted normal breathing where pauses had previously occurred.

The standard treatment remains a continuous positive airway pressure machine, known as CPAP, which forces air into the throat. Many patients refuse the device or avoid diagnosis because of discomfort. Untreated sleep apnea raises risks of heart disease, stroke, and other conditions.

Researchers have tested at least 40 drug candidates over the years without success until the current combination showed results.

Apnimed has raised $260 million from investors including Morningside, Alpha Wave Global, and Sectoral Asset Management. The firm is considering additional fundraising options, including a possible IPO later this year, to support commercial launch. Dr.

Larry Miller, Apnimed's cofounder and CEO, said the company expects millions of patients could use the drug. If approved, the pill could reach the market in the first half of 2027.