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US FDA recommends against Savara seeking approval of lung disorder drug

Savara Inc. said the U.S. Food and Drug Administration has recommended that the company should not seek marketing approval for its drug Molgradex to treat a rare lung disorder.

The FDA noted in its written response that the data for inhaled formulation of Molgradex does not provide enough evidence of the effectiveness and safety of the drug.

The Austin, Texas-based company, which focuses on orphan lung diseases, was developing the drug to treat patients with autoimmune pulmonary alveolar proteinosis, or aPAP, a lung disorder caused by an immune system malfunction.

In June, Savara disclosed results from Impala, a phase 3 trial study of the drug, where Molgradex failed to improve lung function compared to placebo in patients with aPAP.

The company said it is working to determine the next steps for the Molgradex development program.

Savara's stock price was down 57.26% to $1.06 as of 1:30 p.m. ET on Oct. 2.

The U.S. regulator granted Molgradex a fast-track designation in May.