Oncxerna Therapeutics, Inc.

Mereo BioPharma's Setrusumab Phase 3 Trial Progresses; Alvelestat Receives Positive EMA Opinion

6 months ago

• Mereo BioPharma's setrusumab Phase 3 Orbit study for osteogenesis imperfecta is ongoing, with a second interim analysis expected in mid-2025. • Alvelestat, for Alpha-1 Antitrypsin Deficiency-associated Lung Disease, received a positive EMA opinion on its European Orphan Designation application. • The European Commission is expected to make a final decision on Alvelestat's Orphan Designation in the first quarter of 2025. • Mereo BioPharma's current cash and cash equivalents are expected to fund operations into 2027, covering key milestones.

Mereo BioPharma Advances Rare Disease Pipeline with Setrusumab and Alvelestat

a year ago

• Mereo BioPharma's partner, Ultragenyx, anticipates completing enrollment for the Phase 3 Orbit study of setrusumab in Osteogenesis Imperfecta (OI) by the end of Q1 2024. • A global Phase 3 study design for alvelestat in Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD) has been aligned upon following interactions with the FDA. • Mereo BioPharma has signed a global licensing deal with ReproNovo SA for the development and commercialization of leflutrozole. • The company's current cash reserves are projected to sustain operations into 2026, supporting ongoing clinical trials and development programs.

Mereo BioPharma Announces Updated Operating Plan to Maximize Shareholder Value

3 years ago

Mereo BioPharma Group plc has announced an updated operating plan aimed at maximizing shareholder value by reducing headcount by 40% and significantly cutting expenses. The plan extends the company's cash runway into 2026 and focuses on advancing its core rare disease programs. Updates on lead programs include progress on setrusumab for Osteogenesis Imperfecta, alvelestat for Alpha-1 antitrypsin deficiency, and etigilimab in combination with nivolumab for cancer treatment.