The top­i­cal treat­ment for alope­cia area­ta that Aclaris Ther­a­peu­tics li­censed from Rigel Phar­ma has failed a mid-stage study for alope­cia area­ta, leav­ing the com­pa­ny with a drug that seems to have caused no harm but no ben­e­fit ei­ther.

Neal Walk­er Aclaris

While ex­ecs vowed to find a pos­si­ble way for­ward with sub­group analy­sis, the re­sults didn’t leave much room for hope. Nei­ther the 0.46% or 0.12% con­cen­tra­tions of ATI-502 proved su­pe­ri­or to place­bo in im­prov­ing scalp hair cov­er­age — at least not in a sta­tis­ti­cal­ly sig­nif­i­cant way. In fact, an un­ex­pect­ed­ly ef­fec­tive ve­hi­cle out­per­formed the low­er dose on sev­er­al end­points, which were al­ter­na­tive mea­sure­ments of hair loss sever­i­ty.

“We are sur­prised and ex­treme­ly dis­ap­point­ed by the re­sults of this Phase 2 tri­al,” pres­i­dent and CEO Neal Walk­er said in a state­ment.

So were in­vestors. Aclaris’ stock $ACRS has tum­bled 32.58% since the an­nounce­ment Wednes­day at mar­ket close and now sits at $3.00.

It con­tin­ues a down­ward tra­jec­to­ry trig­gered by the FDA’s re­quest for Aclaris to pull a pro­mo­tion­al video on a dif­fer­ent treat­ment sev­er­al days ago, stat­ing that the ad “makes false or mis­lead­ing claims” re­gard­ing their hy­dro­gen per­ox­ide top­i­cal so­lu­tion, Es­ka­ta, for raised se­b­or­rhe­ic ker­atoses.

Aclaris is now pin­ning its hopes on the up­com­ing Phase II read­out of ATI-501, an oral JAK1/JAK3 in­hibitor that goes af­ter the same dis­ease. The ba­sic mech­a­nism re­mains the same — stop­ping T cells from launch­ing an at­tack on fol­li­cle cells — but the hope is it will work for more se­vere pa­tients.

Both ATI-501 and ATI-502 were sub­jects of a 2017 li­cense agree­ment, where Aclaris paid Rigel $8 mil­lion up­front for world­wide rights.

“From a hair loss per­spec­tive we still re­main fo­cused on the cat­e­go­ry broad­ly and look for­ward to the re­sults of the oral work lat­er this year,” a sub­dued Walk­er told an an­a­lyst on a con­fer­ence call.

While the biotech al­so counts a “soft top­i­cal” JAK in its ar­se­nal — ob­tained from a $20 mil­lion buy­out of St. Louis-based Con­flu­ence Life Sci­ences — Walk­er said they are more in­ter­est­ed in de­ploy­ing it for oth­er types of hair loss as well as atopic der­mati­tis.

Aclaris is al­so test­ing ATI-502 for vi­tili­go, an­dro­ge­net­ic alope­cia and atopic der­mati­tis while await­ing Phase III re­sults for A-101, a top­i­cal ther­a­py for com­mon warts.

So­cial im­age: Shut­ter­stock

Celgene’s business team isn’t waiting for the big merger with Bristol-Myers Squibb to go through before syncing its strategy with the new mother ship.

Tuesday evening the big biotech unveiled a $530 million deal — $50 million in upfront cash — to amend their alliance with Jounce Therapeutics $JNCE to gain worldwide rights to JTX-8064, an antibody that targets the LILRB2 receptor on macrophages. Their old, $2.6 billion deal is being scrapped, leaving Jounce with a pipeline that includes the lead drug, the ICOS-targeting vopratelimab.

At PACT Pharma, the lofty goal to unleash a “tsunami” of T cells personalized for each patient has hinged on the ability to correctly identify the neoantigens that form something of a fingerprint for each tumor, and extract the small group of T cells primed to attack the cancer. It still has a long way to go testing a treatment in humans, but the biotech says it has nailed that highly technical piece of the process.

Vivek Ramaswamy’s Myovant $MYOV has closely matched its positive first round of Phase III data for their uterine fibroid drug relugolix, setting up a head-to-head rivalry with pharma giant AbbVie as the little biotech steers to the market with a planned filing in Q4.

Here’s how Myovant plans to prevail over the AbbVie $ABBV empire.

In the study, 71.2% of women receiving once-daily relugolix combination therapy achieved the clinical response they were looking for, compared to only 14.7% in the control arm. The data comfortably reflected the same outcomes in the first Phase III — 73.4% of women receiving once-daily oral relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo — which will reassure regulators that they are getting the carefully randomized data that qualifies for the FDA’s gold standard for success.

The executive team at Sage $SAGE have skirted another potential pitfall on its way to racking up a big future for its depression drug Zulresso.

Little Marinus Pharmaceuticals $MRNS had sought to challenge the Sage drug with an IV formulation — followed by an oral version — of ganaxolone for postpartum depression. But researchers say their Phase II study failed to positively differentiate itself from a placebo at 28 days — leaving them to hold up “clinically meaningful” data within the first day of administration compared to the control arm.

Roche set out to make a better flu medicine than Tamiflu as that franchise was headed to a generic showdown. Now they’ll see just how well Xofluza stacks up against the mainstay drug after handing off over-the-counter rights in the US to Sanofi.

Sanofi $SNY says it will now step in to negotiate a deal with the FDA to steer Tamiflu into the OTC market, a role that could well involve new studies to ease passage of the drug out of doctor’s hands and into the consumer end of the market. And the French pharma giant will have first dibs over “selected” OTC markets around the world as they push ahead.

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.