FDA issues second CRL to Supernus for Parkinson’s drug-device combo

It seems Su­per­nus Phar­ma­ceu­ti­cals will need a su­per ef­fort to get its Parkin­son’s treat­ment ap­proved.

The FDA re­ject­ed the com­pa­ny’s ther­a­py for a sec­ond time in 18 months, with Su­per­nus say­ing in a news re­lease on Mon­day that the reg­u­la­tor doesn’t think the ap­pli­ca­tion for SPN-830 is “ready for ap­proval in its cur­rent form.”

Su­per­nus shares $SUPN were down 10% pre­mar­ket but re­bound­ed slight­ly, trad­ing down about 4% af­ter the mar­ket opened on Mon­day morn­ing.

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