Two months af­ter get­ting ham­mered on the fail­ure of its lead late-stage study for a rare type of seizures, Sage Ther­a­peu­tics is claim­ing a vic­to­ry in a pair of Phase III stud­ies for the same drug in post­par­tum de­pres­sion.

Sage re­port­ed this morn­ing that both of its late-stage stud­ies for brex­anolone (SAGE-547) for ma­jor post­par­tum de­pres­sion suc­cess­ful­ly edged out a place­bo — but failed to reg­is­ter the big im­prove­ment over a sug­ar pill that was seen in Phase II. And the biotech $SAGE says that it will use the da­ta to back an FDA sub­mis­sion for their drug — which re­quires a 60-hour in­fu­sion — next year.

Sage’s shares spiked in pre-mar­ket trad­ing on Thurs­day and then waf­fled for a but. By mid-day, though, the stock was up 51% as in­vestors bought in­to the up­beat tone.

Jeff Jonas

The biotech re­cruit­ed 226 pa­tients for these two stud­ies for an ail­ment that af­flicts huge num­bers of women each year. Typ­i­cal­ly a dis­ease like PPD would in­volve large num­bers of pa­tients in search of two pos­i­tive out­comes, but Sage be­lieves it’s right on track to break new ground and score a ma­jor OK.

The main goal of both stud­ies was a sig­nif­i­cant re­duc­tion in de­pres­sion scores 60 hours af­ter treat­ment. And on that lev­el the drug scored a 17.7-point mean re­duc­tion for the high dose and a 19.9-point im­prove­ment for the low dose in the first study for se­vere PPD com­pared to 14 points in the place­bo arm. In study two there was a 14.2-point vs 12-point dif­fer­ence in the mod­er­ate PPD group.

In Phase II, re­searchers re­port­ed a 12.2-point spread be­tween the drug and the place­bo, leav­ing Sage de­fend­ing a sig­nif­i­cant­ly re­duced mar­gin of im­prove­ment.

Re­searchers al­so not­ed that the drug ef­fect last­ed through 30 days in the first study, but did not mark a sta­tis­ti­cal­ly sig­nif­i­cant im­pact af­ter a month in the sec­ond study for mod­er­ate PPD, which could raise a red flag on dura­bil­i­ty.

That Phase II com­par­i­son may be a bit of a let­down, con­cedes Leerink’s Paul Mat­teis, but a win in Phase III is a ma­jor plus for Sage, which he be­lieves is head­ed for an ap­proval. Get­ting an oral ver­sion, he adds, would be a tremen­dous boost.

Nonethe­less, the pos­i­tive phase III PPD re­sults are a tech­nol­o­gy val­i­dat­ing event for SAGE who is seek­ing to re­ca­pit­u­late the mech­a­nism of bre­nax­olone in an oral for­mu­la­tion (SAGE-217) across an ar­ray of CNS dis­or­der. In the back­drop of a planned NDA fil­ing for bre­nax­olone, oral da­ta in ma­jor de­pres­sive dis­or­der rep­re­sent the next ma­jor event in 4Q.

There was at least one se­ri­ous ad­verse event as­so­ci­at­ed with the drug, which was not ex­plained in the com­pa­ny’s state­ment. But Sage says the safe­ty pro­file over­all was com­pa­ra­ble to the place­bo arm. More da­ta will be re­leased at an sci­en­tif­ic con­fer­ence.

Sage has mus­tered fierce sup­port as well as plen­ty of crit­ics for its R&D strat­e­gy, us­ing small stud­ies to high­light the po­ten­tial of a drug. And in this case, PPD rep­re­sents the kind of ma­jor mar­ket op­por­tu­ni­ty like­ly to re­quire a sig­nif­i­cant amount of da­ta to win over reg­u­la­tors.

Last Sep­tem­ber the biotech re­port­ed that the drug did no bet­ter than a sug­ar pill in treat­ing su­per-re­frac­to­ry sta­tus epilep­ti­cus.

Now we’ll see how the FDA feels about all of this.

Sage CEO Jeff Jonas tout­ed the re­sults as a game chang­er:

We be­lieve the da­ta rep­re­sent an un­prece­dent­ed op­por­tu­ni­ty in the de­vel­op­ment of treat­ments for PPD, and may serve as the cat­a­lyst for a par­a­digm shift in how the dis­ease is ap­proached and, if ap­proved, may change how PPD is treat­ed.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.