Apnimed is having sweet dreams of an IPO that could fund the planned commercial launch of an obstructive sleep apnea (OSA) therapy that is currently awaiting an FDA approval decision.
The therapy, called Oxnimbi or AD109, is a drug combination that targets a cause of upper airway collapse in people with OSA. Apnimed reported two phase 3 wins for AD109 in 2025 and submitted an approval application to the FDA in April this year.
That application included data from last year's 660-patient LunAIRo study, which demonstrated a 46.8% reduction in the number of nightly breath-stopping events for individuals taking Oxnimbi at 26 weeks, compared to just a 6.8% drop for the placebo cohort.
The Massachusetts-based company has yet to set out how many shares it expects to offer—or at what price—but disclosed in a July 10 Securities and Exchange Commission filing that the top priority for the IPO proceeds would be funding the regulatory process for Oxnimbi in OSA as well as a potential commercial launch.
Oxnimib is a combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a noradrenaline reuptake inhibitor that is also used in attention-deficit/hyperactivity disorder. The once-daily pill targets the motor neurons that control breathing during sleep and boosts their activity so that throat muscles don’t relax, which is what causes breathing disruptions in patients with OSA.
Should Oxnimib get approved, it would become the first prescription drug designed specifically for adults with sleep apnea—of which there are an estimated 80 million in the U.S. alone. While Eli Lilly’s Zepbound became the first ever FDA-approved sleep apnea med in December 2024, it is only approved for adults with obesity.
The most common treatment for apnea at the moment is wearing a cumbersome mask hooked up to a CPAP machine while sleeping. That device pumps air into the airway so that pressure doesn’t drop low enough for muscles to collapse.
The approval application is for OSA in adults, but Apnimed suggested it may seek to expand the indication to children and adolescents at some point in the future.
While Oxnimib is Apnimed’s sole clinical-stage treatment, the company said it is also working on preclinical-stage programs focused on sleep-related breathing disorders and related comorbidities. Apnimed said in the filing that it may use a slice of the IPO proceeds to fund this R&D work, as well as license suitable drugs if it comes across them.
Apnimed had been running a joint venture with Shionogi since 2023, with the companies kicking off a phase 2a trial of a sleep disorder candidate last year while adding a second asset to that entity’s pipeline. However, Apnimed agreed to sell its side of the venture to Shionogi for $100 million upfront in March.
Around the time that deal was signed, Apnimed had $46.9 million in the bank and employed 65 people full-time, according to Friday’s filing.
Apnimed is now headed up by Kevin Lind, who took over as CEO last month from Apnimed founder Lawrence Miller, M.D. Lind had previously set up Longboard Pharmaceuticals and served as the neuro biotech’s CEO through to its $2.6 billion acquisition by Lundbeck in 2024.
Apnimed has been gearing up for a commercial launch for a while, including tapping Pfizer veteran Graham Goodrich as chief commercial officer at the start of 2024.
The company's potential path to the Nasdaq follows a boom period for biotech IPOs, including recent record-breaking listings from the likes of Kailera Therapeutics and Parabilis Medicines.