Scholar Rock Pulls Europe Drug Filing
Scholar Rock withdrew its European application for its muscle weakness drug following manufacturing issues at a partner facility. The company plans to resubmit the filing using an alternative site to expedite review.
Insights:
Scholar Rock pulled its European application for apitegromab on Friday afternoon, shifting to an alternative manufacturing site after inspection hurdles. The withdrawal resets a key regulatory review for the spinal muscular atrophy treatment in Europe. The setback tests investor patience as the firm works toward a potential U.S. decision by September 30.
