A Flori­da biotech at­tempt­ing to de­vel­op a rapid-act­ing an­ti­de­pres­sant ran face-first in­to a brick wall Thurs­day.

Rel­ma­da Ther­a­peu­tics re­port­ed a Phase III fail for its lead com­pound, REL-1017, in ma­jor de­pres­sive dis­or­der, not­ing the pro­gram did not sep­a­rate from place­bo af­ter 28 days in a de­pres­sion rat­ing scale mea­sur­ing se­vere episodes. Though the da­ta were nu­mer­i­cal­ly sim­i­lar, Rel­ma­da did not re­port a p-val­ue to il­lus­trate by how much REL-1017 whiffed.

In­vestors were hav­ing none of it. Be­fore the mar­ket opened Thurs­day morn­ing, Rel­ma­da shares $RLMD cratered near­ly 80%, send­ing the stock price to its low­est point in more than three years.

Re­searchers were at­tempt­ing to show an an­ti­de­pres­sive ef­fect us­ing the Mont­gomery-As­berg De­pres­sion Rat­ing Scale, which quan­ti­fies the sever­i­ty of de­pres­sive episodes in adults. Af­ter 28 days, pa­tients who took the drug saw their scores de­crease by 14.8 points com­pared to 13.9 points from those on place­bo.

Rel­ma­da blamed an un­fore­seen spike in the place­bo re­spons­es, de­scrib­ing re­sults from cer­tain tri­al sites as “para­dox­i­cal.” The biotech says it will try to fig­ure out why this proved to be the case, go­ing as far as to say a post-hoc analy­sis that ex­clud­ed the ques­tion­able sites showed a sta­tis­ti­cal­ly sig­nif­i­cant ben­e­fit.

The goal is to cre­ate a de­pres­sion drug that acts rapid­ly, as op­posed to ap­proved SS­RIs that may take weeks to start work­ing. The FDA ap­proved a rapid-act­ing NM­DA re­cep­tor an­tag­o­nist for MDD in Au­gust, to be mar­ket­ed as Au­veli­ty by Ax­some Ther­a­peu­tics.

Rel­ma­da is run­ning two ad­di­tion­al Phase III stud­ies to see if REL-1017 works in com­bi­na­tion with oth­er ther­a­pies. But Thurs­day’s fail­ure makes the biotech’s mar­gin for er­ror ra­zor-thin giv­en this is Rel­ma­da’s on­ly clin­i­cal pro­gram.

Pre­vi­ous stud­ies had shown two dose lev­els to be ef­fec­tive in treat­ment-re­sis­tant de­pres­sion. REL-1017 is de­signed as a pill tak­en oral­ly once per day. The biotech’s oth­er pro­gram fo­cus­es on psilo­cy­bin and its de­rivates af­ter sign­ing a li­cense agree­ment last year with Ar­bor­men­tis.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.