Neu­ro­crine was forced to con­cede that its lead drug – al­ready on track at the FDA with an ap­pli­ca­tion for tar­dive dysk­i­ne­sia — just flunked a Phase II tri­al in Tourette syn­drome.

The VMAT2 in­hibitor im­proved symp­toms among the pa­tients tak­ing the drug, but failed to hit the pri­ma­ry end­point for the change-from-base­line in the Yale Glob­al Tic Sever­i­ty Scale at week 8. The biotech, though, is keep­ing the hard da­ta un­der wraps for now.

Don’t look for the com­pa­ny $NBIX to throw in the tow­el. Their state­ment im­plied that they’re go­ing to take what they learned from this set­back and ap­ply it again in an­oth­er study.

Their stock slid a bit more than 5% in af­ter-hours trad­ing, an ini­tial in­di­ca­tion that in­vestors didn’t see the set­back as cat­a­stroph­ic.

“At present, we are not dis­clos­ing spe­cif­ic de­tails of this study in or­der to avoid the po­ten­tial in­tro­duc­tion of as­sess­ment bias in the on­go­ing Phase II T-Force GREEN study of pe­di­atric Tourette pa­tients,” not­ed CEO Kevin Gor­man. “We look for­ward to the pe­di­atric study read­out next quar­ter and our sub­se­quent dis­cus­sion with the FDA on our plans for Phase III de­vel­op­ment of In­grez­za in Tourette syn­drome.”

A to­tal of 124 pa­tients were en­rolled in 32 cen­ters.

Just a few days ago the FDA an­nounced that they were scrap­ping plans for a pan­el re­view of the drug for tar­dive dysk­i­ne­sia, a move that sev­er­al an­a­lysts took as a pos­i­tive in­di­ca­tion of its re­cep­tion at the agency. The PDU­FA date for that in­di­ca­tion is set for April 11.

Chris O’Brien, the chief med­ical of­fi­cer of Neu­ro­crine, said:

Through this ini­tial place­bo-con­trolled study we gained valu­able in­sights in­to the con­duct of clin­i­cal tri­als in Tourette pa­tients, in­clud­ing pa­tient iden­ti­fi­ca­tion meth­ods and ap­pro­pri­ate study in­clu­sion/ex­clu­sion cri­te­ria. As we have done with our pre­vi­ous ear­ly Phase II stud­ies in both en­dometrio­sis and tar­dive dysk­i­ne­sia, we will ap­ply these new in­sights to fu­ture Tourette stud­ies.

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

Codiak BioSciences has filed for Chapter 11 bankruptcy, spelling an end to the employment of most executives, including founder Doug Williams, as the biotech says it “expects to consummate a sale.”

The eight-year journey at Codiak is nearing an end with Williams; CFO Linda Bain; medical chief David Mauro; scientific head Sriram Sathyanarayanan; legal and compliance chief Yalonda Howze; and SVP of HR Nicole Barna all packing up their bags in the first few days of April. Chief technology officer Konstantin Konstantinov will stay.

Biotech Intra-Cellular Therapies touting new data Tuesday for its drug designed to treat major depressive disorder.

The biotech shared results from its Study 403 investigating lumateperone, or Caplyta, as a monotherapy to treat major depressive episodes. The study looked at major depressive disorder (MDD) and bipolar depression with “mixed features.” The trial had three populations: participants with both MDD and bipolar depression, patients with only MDD and patients with only bipolar depression.