Bavarian Nordic gets Breakthrough status for its RSV vaccine candidate

Shares of Bavarian Nordic (OMX: BAVA) were down 3.7% at 164.55 Danish kroner by late morning today, despite announcing that the US Food and Drug Administration has granted Breakthrough Therapy designation for the Danish company's vaccine candidate, MVA-BN RSV, for active immunization for prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults aged 60 years or older.

The designation has been granted upon the assessment of preliminary clinical evidence for MVA-BN RSV, indicating that the vaccine candidate may demonstrate substantial improvement over available therapy on a clinically significant endpoint. The designation provides an option to work more closely with the FDA for the development and review of MVA-BN RSV, Bavarian Nordic noted.

Candidate has a clearly differentiated approach