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

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Two and a half years after setting out on another foray into oncology R&D, a biotech headed by David Hung — of Medivation fame — has run into its first setback.

San Francisco-based Nuvation Bio announced early Monday the FDA placed a partial clinical hold on a Phase I dose-escalation study of NUV-422, its CDK inhibitor program for certain types of solid tumors. The trial began enrolling patients in December 2020, and, according to Nuvation, researchers were in the middle of exploring dose escalation and defining the maximum dose tolerable in patients.