$Minerva Neurosciences (NERV.US)$ Roluperidone NDA receives CRL from FDA 🙁 ⚠️ FDA cited clinical deficiencies: ▪️ Insufficient substantial evidence of effectiveness ▪️ lacks data on concomitant antipsychotic admin. ▪️ lacks data to establish change in negative symptoms of schizophrenia ▪️ inadequate number of subjects exposed at proposed dose ℹ️Add'l info on Roluperidone… ⇒ for negative symptoms of schizophrenia ⇒ NDA ⇒ PDUFA: 02/26/24
$Viking Therapeutics (VKTX.US)$skyrocketed 77% after positive drug trial news Tuesday, leading to what proved to be a strong morning for pharmaceutical stocks. Here are some top stocks in the sector climbing on drug trial and earnings news: $Janux Therapeutics (JANX.US)$shares shot up 205% to $36.00 after the company announced updated clinical data for both of its clinical programs, reaching over $1.50B in market cap. $Ligand Pharmaceuticals (LGND.US)$gained 23%...
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Roluperidone NDA receives CRL from FDA 🙁
⚠️ FDA cited clinical deficiencies:
▪️ Insufficient substantial evidence of effectiveness
▪️ lacks data on concomitant antipsychotic admin.
▪️ lacks data to establish change in negative symptoms of schizophrenia
▪️ inadequate number of subjects exposed at proposed dose
ℹ️Add'l info on Roluperidone…
⇒ for negative symptoms of schizophrenia
⇒ NDA
⇒ PDUFA: 02/26/24
Here are some top stocks in the sector climbing on drug trial and earnings news:
$Janux Therapeutics (JANX.US)$shares shot up 205% to $36.00 after the company announced updated clinical data for both of its clinical programs, reaching over $1.50B in market cap.
$Ligand Pharmaceuticals (LGND.US)$gained 23%...
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