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).
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial