FDA spurns Su­per­nus for Parkin­son's drug, not­ing ap­pli­ca­tion is­sues 'across sev­er­al ar­eas'

Su­per­nus has found it­self in the crosshairs of the FDA once again.

A pitch for a Parkin­son’s dis­ease treat­ment was re­ject­ed by reg­u­la­tors, the biotech an­nounced Mon­day, send­ing it back to the ap­pli­ca­tion draw­ing board. The re­jec­tion is not the first time this pro­gram, dubbed SPN-830, has faced scruti­ny: Su­per­nus pre­vi­ous­ly re­ceived an RTF for it back in No­vem­ber 2020.

Mon­day’s news ini­tial­ly sent Su­per­nus shares down about 10% pre-mar­ket, but the stock re­bound­ed to about flat in ear­ly morn­ing trad­ing. “SPN-830 re­mains a key pri­or­i­ty for Su­per­nus,” CEO Jack Khat­tar said in pre­pared re­marks.

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