Savara plunges after FDA refuses to accept application for lung disease drug

Shares of drugmaker Savara SVRA.O fall 34.86% to $1.85 premarket

Co receives FDA's 'Refusal to File' (RTF) letter for its application for its therapy Molbreevi to treat patients with autoimmune PAP, a rare lung disease

Upon preliminary review, the FDA says it determined that co's application submitted in March 2025 was not sufficiently complete to permit substantive review and requested additional data related to chemistry, manufacturing and controls

Co says FDA did not request or recommend additional efficacy studies and RTF is not the result of safety concerns

SVRA expects to resubmit application in Q4

Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of proteins and fats in the alveoli of lungs

Up to last close, stock down 7.5% YTD