Aclaris Ther­a­peu­tics has found a way to get rid of the warts and all.

The com­pa­ny — which ear­li­er this month de­cid­ed to fo­cus on its ar­se­nal of ki­nase in­hibitors — on Mon­day un­veiled pos­i­tive da­ta from a piv­otal study test­ing its lead ex­per­i­men­tal drug for use in com­mon warts.

The drug, A-101, was test­ed in a 502-pa­tient study called THWART-2 — pa­tients en­rolled had one to six warts be­fore qual­i­fy­ing for the tri­al. Pa­tients ei­ther self-ad­min­is­tered A-101 top­i­cal so­lu­tion or a ve­hi­cle twice a week over a two-month pe­ri­od. A high­er pro­por­tion of pa­tients on the drug (a po­tent hy­dro­gen per­ox­ide top­i­cal so­lu­tion) saw their warts dis­ap­pear at day 60, ver­sus the ve­hi­cle (p<0.0001) — meet­ing the main goal of the study.  Each sec­ondary end­point al­so emerged in fa­vor of A-101, the com­pa­ny said.

Shares of the Wayne, Penn­syl­va­nia-based com­pa­ny $ACRS soared about 65.5% to $1.82 in pre­mar­ket trad­ing on Fri­day.

An­oth­er late-stage tri­al in com­mon warts is on­go­ing, and da­ta are ex­pect­ed in the fourth quar­ter.

“Giv­en no FDA ap­proved treat­ments for com­mon warts, which im­pacts 22M Amer­i­cans each year, it seems that there would be a rel­a­tive­ly ‘low bar’ for A-101 45% to re­ceive ap­proval, as­sum­ing the con­fir­ma­to­ry Ph3 THWART-1 da­ta al­so reads out pos­i­tive­ly,” Jef­feries an­a­lysts wrote in a note.

“With on­ly topline in­for­ma­tion, it is dif­fi­cult to com­pare to the pri­or A-101 Ph2 datasets as well as VR­CA’s re­cent­ly re­port­ed Ph2 da­ta for VP-102 in treat­ing com­mon warts.”

Ver­ri­ca Phar­ma­ceu­ti­cals $VR­CA ear­li­er this year dis­closed pos­i­tive da­ta from an open-la­bel mid-stage study test­ing its drug, VP-102, in pa­tients with up to six warts. Da­ta skewed in fa­vor of VP-102 on the pri­ma­ry end­point of com­plete clear­ance of all treat­able warts at day 84, as well as the sec­ondary goal of the per­cent­age re­duc­tion of warts. The top­i­cal ther­a­py com­pris­es a so­lu­tion of 0.7% can­tharidin — a blis­ter-in­duc­ing agent se­cret­ed by cer­tain bee­tles — which was his­tor­i­cal­ly used as an aphro­disi­ac. Top­i­cal can­tharidin has been used on warts and mol­lus­cum since the 1950s, al­though the chem­i­cal lost FDA ap­proval in 1962 af­ter man­u­fac­tur­ers failed to fur­nish ad­e­quate ev­i­dence sup­port­ing its ef­fi­ca­cy.

Weeks ago, Aclaris con­clud­ed a strate­gic re­view of its busi­ness — re­solv­ing to fo­cus its re­sources on its im­muno-in­flam­ma­to­ry pipeline (en­com­pass­ing ATI-450, ATI-1777 and oth­er pre­clin­i­cal drug can­di­dates). It is now look­ing for part­ners on its com­mer­cial busi­ness: Rosacea treat­ment Rhophade and se­b­or­rhe­ic ker­atoses ther­a­py Es­ka­ta. In ad­di­tion, the com­pa­ny is al­so seek­ing part­ners for a tri­fec­ta of ther­a­pies in de­vel­op­ment — ex­per­i­men­tal warts drug A-101, as well as the in­ves­ti­ga­tion­al alope­cia treat­ments ATI-501 (oral) and ATI-502 (top­i­cal).

As a re­sult, the com­pa­ny an­nounced 86 lay­offs. The re­struc­tur­ing is ex­pect­ed to keep the lights on un­til the third quar­ter of 2021.

“While we hold the mgt team in high re­gard as thought lead­ers in der­ma­tol­ogy, the com­pa­ny has ex­e­cut­ed poor­ly over the past year (e.g., botched Es­ka­ta launch, mixed clin­i­cal da­ta for the JAK alope­cia pro­grams)…” Jef­feries an­a­lysts said in a note dat­ed Sep­tem­ber 6.

In June, the com­pa­ny suf­fered a set­back af­ter a mid-stage study test­ing ATI-502 failed to im­prove scalp hair cov­er­age, which crushed its stock. Aclaris paid Rigel Phar­ma $8 mil­lion up­front in 2017 for glob­al li­cens­es to both ATI-501 and ATI-502.

The dis­clo­sure came days af­ter the FDA rep­ri­mand­ed the com­pa­ny for mak­ing “false or mis­lead­ing claims” in a pro­mo­tion­al video for Es­ka­ta.

“That said, we see val­ue in the cur­rent cap­i­tal­iza­tion. Look­ing ahead, with a sub $40M mar­ket val­ue (trad­ing at ~0.45x net cash), ACRS shares could re­bound if mgt can ex­e­cute on its re­vamped strat­e­gy,” the an­a­lysts added.

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.