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The Markets
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Pharma & Biotech

Numinus Wellness positioned to lead in MDMA-assisted therapy as FDA approval nears

Numinus Wellness Inc. (TSX:NUMI, OTC:LKYSF) said it is well-positioned to be a key provider of MDMA-assisted therapy (MDMA-AT) as it expects Food and Drug Administration (FDA) approval for the therapy in 2024.

The company said, in anticipation of regulatory approval, it has taken initiatives to prepare for a rapid rollout of MDMA-AT services, including the reallocation of resources towards revenue-producing activities, cost containment initiatives, and preparation for insurance reimbursement systems.

"With the Multidisciplinary Association for Psychedelic Studies (MAPS) anticipated to receive approval for MDMA-assisted therapy in the first half of 2024, we're excited to be positioned as a leading psychedelic-assisted therapy clinical operator and we're already taking steps to ensure Numinus is ready to provide broader access to this important treatment as soon as regulators allow," Numinus CEO Payton Nyquvest said in a statement.

Among its initiatives, Numinus highlighted that its cost containment measures have resulted in approximately $4.2 million of annualized savings, extending the company’s cash runway past anticipated MDMA approval.

Additionally, the company noted it was positioned to provide psychedelic-assisted therapy insurance reimbursement, with a well-established US insurance payor program in place.

The company expects its insurance-payor relationships and infrastructure will provide the opportunity for it to reimburse its clients for future psychedelic-assisted therapies.

Numinus Wellness is a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies.

Contact the author at emily.jarvie@proactiveinvestors.com

Follow her on Twitter @emilyjjarvie

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