Research & Development
Moberg Pharma plans to meet with regulators to discuss new topical treatment for onychomycosis
14 October 2020 -

Swedish pharmaceutical company Moberg Pharma AB (STO:MOB) revealed on Wednesday that it intends to request pre-submission meetings with regulatory agencies concerning MOB-015, its main asset.

MOB-015 is a novel topical treatment for onychomycosis, a fungal nail infection.

Moberg Pharma presented topline results in June 2020 from the second of two clinical Phase 3 studies for MOB-015. The company will now finalise the necessary documentation and expects to submit a registration application in Europe in the second half of 2021.

"After thorough analysis of the data with our scientific advisors and partners, we see strong potential for MOB-015 and are now through submission preparations pursuing the next key steps toward market approval," said Anna Ljung, CEO of Moberg Pharma. "There is great need for better topical treatments with the ability to really cure the fungal infection. The superior mycological cure enables a unique position for MOB-015."

After the European meetings, Moberg Pharma intends to discuss next steps for the US market in an advice meeting with the US Food and Drug Administration (FDA).

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