MREO - Mereo stock rises 12% on FDA fast-track status for lung disease drug alvelestat

• The U.S. Food and Drug Administration (FDA) granted fast track designation to Mereo BioPharma alvelestat (MPH-966) to treat Alpha-1 Antitrypsin Deficiency (AATD)-associated lung disease.
• The London-based company said it plans to have an end-of-phase 2 meeting with the FDA to discuss the design of a registration-enabling study for alvelestat for AATD-associated lung disease, including a potential opportunity for an accelerated approval pathway.
• AATD is a genetic disorder characterized by low levels of a protein called alpha-1 antitrypsin (A1AT). The disorder can cause pulmonary emphysema, a progressive lung disease, which can cause shortness of breath, chronic cough and asthma, according to the company.
• Mereo said it intends to provide update on Oct. 31 on a phase 2 trial called ASTRAEUS of alvelestat in severe AATD-associated emphysema — top-line data from which were reported in May.
• MREO +12.01% to $1.12 premarket Oct. 17

For further details see: