Moberg Pharma AB

Moberg Pharma's MOB-015 Fails Primary Endpoint in North American Phase 3 Onychomycosis Trial

5 months ago

• Moberg Pharma's MOB-015 did not meet the primary endpoint in its North American Phase 3 trial for onychomycosis using an 8-week daily dosing regimen followed by weekly maintenance. • The study's results indicated that the reduced dosage regimen was insufficient, reinforcing the need for a longer daily treatment, as approved in the EU, for effective topical treatment. • Bayer Consumer Health will halt the launch of MOB-015 due to strategic reasons, leading Moberg Pharma to regain full rights for MOB-015 in the EU and reassess its US strategy. • Moberg Pharma will shift its focus to the European market, aiming for a stronger presence and commercial role, while also exploring potential partnerships for further development.

Moberg Pharma's MOB-015 Phase 3 Trial Shows Lower Than Expected Clinical Cure Rate

8 months ago

• Moberg Pharma reports that a subset of patients in their North American Phase 3 study of MOB-015 achieved clinical cure for nail fungus at a rate lower than anticipated. • Cipher Pharmaceuticals, which holds Canadian marketing rights to MOB-015, acknowledges the update from Moberg Pharma regarding the clinical trial results. • Cipher Pharmaceuticals emphasizes that the outcome of the MOB-015 trial does not currently impact the company's sales and earnings profile. • Cipher Pharmaceuticals remains focused on the integration of the Natroba™ business and other potential growth opportunities.

Moberg Pharma's MOB-015 Phase 3 Trial Faces Uncertainty After Subgroup Analysis

8 months ago

• Moberg Pharma reports lower than expected clinical cure rates in a subset of patients from its ongoing North American Phase 3 trial of MOB-015 for onychomycosis. • The Phase 3 study, conducted across 33 centers in the US and Canada with 384 patients, is crucial for potential US registration and commercialization of MOB-015. • The company emphasizes data integrity and awaits topline results before speculating on the future potential of MOB-015, a topical terbinafine formulation. • Moberg Pharma will host a conference call to discuss the implications of these findings with its CEO, CMO, and CSO.