STOCKHOLM, Oct. 6, 2023 /PRNewswire/ -- Moberg Pharma AB (OMX: MOB) has completed the recruitment of 384 patients with onychomycosis (nail fungus) for the ongoing MOB-015 phase 3 study in North America. The aim is to provide a pivotal part of the clinical data set for registration and commercialization of MOB-015 in the U.S.. Topline results are expected in January 2025.
Moberg Pharma AB (OMX: MOB) has signed a distribution agreement with Padagis Israel Agencies Ltd. for MOB-015 in Israel and the Palestinian...
STOCKHOLM, Nov. 8, 2021 /PRNewswire/ -- Moberg Pharma AB (OMX: MOB) has entered into a collaboration with Allderma AB for the launch of MOB-015 (for nail fungus) in Sweden, Norway and Denmark. Allderma is managed by the commercial leaders which were responsible for the successful Nordic launch of Nalox®, Moberg Pharma's first-generation nail fungus product.
STOCKHOLM, Sept. 22, 2021 /PRNewswire/ -- Moberg Pharma AB (OMX: MOB) today announces that it has received approval of the pediatric plan for MOB-015 from EMA's paediatric committee (PDCO). This approval enables the company to pursue a full marketing authorization application providing up to ten years of exclusivity in Europe following approval. The company's timeline remains, with planned submission for MOB-015 in Europe this year and expected market approval in 2023.
STOCKHOLM, Nov. 6, 2020 /PRNewswire/ -- The Board of Directors of Moberg Pharma AB (OMX: MOB) today announces its intention to distribute the operations of BupiZenge® (BUPI) to the shareholders of Moberg Pharma by distributing 90 percent of the shares in a subsidiary (name to be changed to OncoZenge AB) through a so-called Lex ASEA distribution, and convenes an extraordinary general meeting to resolve accordingly. The business consists of developing the BUPI project under the brand name BupiZenge® for treatment of oral mucositis. Moberg Pharma estimates the capital requirement to take BupiZenge® through phase 3 at SEK 60 million. Moberg Pharma is therefore evaluating the opportunity to distribute OncoZenge according to Lex Asea and list its shares on Nasdaq First North Growth Market. Moberg Pharma has hired Erik Penser Bank to evaluate opportunities for financing OncoZenge as a separate company.
STOCKHOLM, Oct. 14, 2020 /PRNewswire/ -- Moberg Pharma AB (OMX: MOB) announced today its decision to request pre-submission meetings with regulatory agencies, with the goal of submitting a registration application in the second half of 2021 in Europe.
STOCKHOLM, June 25, 2020 /PRNewswire/ -- Moberg Pharma AB (OMX: MOB) announces that MOB-015 (topical terbinafine) met the primary endpoint in the European Phase 3 study including 452 onychomycosis patients, showing non-inferiority versus topical ciclopirox. Mycological cure was achieved in 84 percent of patients, which is unprecedented for a topical treatment and even higher than reported for oral treatments. The pattern is consistent with the results from the North American Phase 3 study, with low complete cure rates despite the high mycological cure rates. Moberg Pharma will discuss next steps with partners and regulatory agencies.
Moberg Pharma AB (OMX: MOB) has now completed the expert evaluation of the results from the North American Phase 3-study. The analysis conducted with key opinion leaders (KOLs) has confirmed the validity of the data presented in December 2019 and increased the understanding of the study outcomes. Key conclusions include: i) MOB-015 delivers a very high mycological cure rate that compares favorably to oral antifungal drugs with the added advantage of an earlier onset of action; ii) Confirmation that the proprietary vehicle technology increases the hydration and permeability of the nail plate enabling efficient terbinafine delivery, however it also confounds the assessment of clinical cure and complete cure and iii) A likely solution to the problem - a shorter dosing regimen with the potential to deliver superior complete cure rates.