U.S. FDA Approves Nova Mentis Orphan Drug Application

Rhea-AI Summary

Nova Mentis Life Science Corp. has received approval from the U.S. FDA for its psilocybin drug's Orphan Drug Application targeting Fragile X Syndrome (FXS), the leading inherited cause of autism. This designation grants NOVA significant benefits, including seven to ten years of market exclusivity and eligibility for federal tax credits. Notably, NOVA is the first biotech firm to have psilocybin recognized for FXS treatment by both FDA and EMA. The company plans to initiate phase 2 clinical studies supported by real-world evidence data.

Positive

• FDA approval of psilocybin for FXS provides seven to ten years of market exclusivity.
• Tax benefits including 25% federal tax credit for clinical research costs.
• Eligibility to apply for competitive research grants for clinical studies.

Negative

• None.

Psilocybin Fragile X Syndrome Treatment

 VANCOUVER, BC, Nov. 2, 2021 /PRNewswire/ - Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) ("NOVA" or the "Company"), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders, is pleased to announce that the U.S. FDA has approved the Company's proprietary psilocybin drug Orphan Drug Application to  treat patients with fragile X syndrome (FXS), the most common inherited cause of autism spectrum disorder (ASD).

"NOVA has established a unique position in the field of psychedelic therapy by having its FXS program achieve orphan drug status in both the United States and European Union,"says Will Rascan, NOVA's CEO & President. "I am pleased to announce that we are the first biotech company to have psilocybin registered for treatment of FXS in the drug regulatory logs of both the FDA and EMA."

Medicines that have been granted an orphan designation from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) receive  benefits, including but not limited to: 

• Seven-Ten years of market exclusivity: FDA and EMA cannot approve the same drug for the same indication.
• 25% federal tax credit for expenses incurred in conducting clinical research within the United States.
• Waiver of Prescription Drug User Fee Act (PDUFA) fees: a value of approximately $2.9 million.
• Ability to qualify to compete for research grants from the Office of Orphan Products Development (OOPD) to support clinical studies.
• Eligibility to receive regulatory assistance and guidance from the FDA in the design of an overall drug development plan.

"The attainment of Orphan Drug status in both the U.S. and Europe is a significant milestone towards launch of psilocybin FXS phase 2 clinical studies," stated Dr. Marvin S. Hausman MD, Chairman of NOVA's Scientific Advisory Board. "The U.S. FDA has issued guidance concerning the usage of observational clinical study Real-World Evidence (RWE) to support the potential benefits of a medical product ⁽¹⁾.  NOVA intends to immediately launch an IRB approved ASD observational study to provide baseline clinical biomarker RWE data in support of its psilocybin IND to treat FXS."  

(1)   https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence 

About Nova Mentis Life Science Corp.

Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. The goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and Fragile X Syndrome (FXS).

On Behalf of the Board

Will Rascan, President & CEO
Nova Mentis Life Science Corp.

Phone: 778-819-0244
Toll Free: 1-833-542-5323

Twitter: @novamentislsc
Instagram: @novamentislsc
Facebook: @novamentislsc

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

This news release contains statements that constitute "forward-looking statements." Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause Nova Mentis Life Science's actual results, performance or achievements, or developments in the industry to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects," "plans," "anticipates," "believes," "intends," "estimates," "projects," "potential" and similar expressions, or that events or conditions "will," "would," "may," "could" or "should" occur.

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SOURCE Nova Mentis Life Science Corp.

FAQ

What is the significance of the FDA approval for Nova Mentis's psilocybin drug (NMLSF)?

The FDA approval allows Nova Mentis's psilocybin drug to be used to treat Fragile X Syndrome, providing significant market exclusivity and tax incentives.

How does orphan drug status benefit Nova Mentis (NMLSF)?

Orphan drug status grants benefits such as market exclusivity, tax credits for research, and waived fees, enhancing Nova's competitive edge.

What are the next steps for Nova Mentis after FDA approval (NMLSF)?

Nova Mentis plans to launch phase 2 clinical studies and conduct observational studies to support its IND for FXS.

How does Nova Mentis (NMLSF) differentiate itself in the biotechnology space?

Nova Mentis is a leader in psilocybin-based therapeutics for neuroinflammatory disorders, with unique regulatory approvals in both the U.S. and Europe.