Two years ago, Ver­ri­ca Phar­ma land­ed a $75 mil­lion IPO on the promise they could de­vel­op the first ever-FDA ap­proved drug for mol­lus­cum con­ta­gio­sum, an in­fec­tion that caus­es warts. Now that won’t hap­pen, at least not this sum­mer.

The FDA to­day re­ject­ed Ver­ri­ca’s ap­pli­ca­tion to have their lead top­i­cal drug VP-102 ap­proved for mol­lus­cum con­ta­gio­sum. The news like­ly came as lit­tle sur­prise to Ver­ri­ca or its in­vestors; the biotech dis­closed in late June that the FDA sent a let­ter say­ing “de­fi­cien­cies” in their ap­pli­ca­tion pre­clud­ed a dis­cus­sion around la­bel­ing or post-mar­ket­ing com­mit­ments.

Ver­ri­ca said the FDA want­ed more in­for­ma­tion on CMC — chem­istry, man­u­fac­tur­ing and con­trols — along with hu­man fac­tors, i.e. how a user will ac­tu­al­ly han­dle the prod­uct in the re­al world. In the June let­ter, Ver­ri­ca said the FDA had raised con­cerns about a change the com­pa­ny had made af­ter it be­came clear that a cer­tain safe­ty is­sue could arise if health­care work­ers did not cor­rect­ly fol­low the in­struc­tions for ap­ply­ing their ther­a­py. Ver­ri­ca added a fea­ture to ad­dress that is­sue, but that fea­ture af­fect­ed hu­man fac­tors test­ing and re­quired “ad­di­tion­al sta­bil­i­ty da­ta.”

The com­pa­ny said “the FDA did not iden­ti­fy any clin­i­cal de­fi­cien­cies.” They are sched­ul­ing a meet­ing with the agency short­ly to dis­cuss next steps.

Ted White

“We are con­fi­dent that we can work close­ly with the FDA to ful­ly ad­dress the is­sues raised in the let­ter and we con­tin­ue to be­lieve VP-102 re­mains vi­able for FDA ap­proval,” CEO Ted White said.

De­spite the re­jec­tion, Ver­ri­ca’s stock stayed buoy­ant, dip­ping just 3% on the news. That’s per­haps be­cause the com­pa­ny is aim­ing for oth­er in­di­ca­tions and be­cause the da­ta from piv­otal tri­als for VP-102 bol­ster the odds of even­tu­al ap­proval.

In one Phase III study re­leased last sum­mer, 46% of pa­tients who re­ceived VP-102 saw their warts clear com­plete­ly, com­pared to 18% for place­bo. In a sec­ond Phase III tri­al, 54% saw com­plete clear­ance, com­pared to 13% for place­bo. Over­all, pa­tients who re­ceived the drug saw a 69% and 83% re­duc­tion in le­sions, re­spec­tive­ly.

Ver­ri­ca is al­so now test­ing VP-102 in com­mon warts. Most re­cent­ly, they an­nounced that, in an open-la­bel Phase II study, 51% of pa­tients who re­ceived the high dose of the drug saw com­plete clear­ance of their le­sions by day 84. They will use that dose in a Phase III tri­al. A Phase II tri­al in gen­i­tal warts is al­so on­go­ing, and a Phase II for plan­tar warts will start soon.

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

AstraZeneca’s big gamble on Daiichi Sankyo’s antibody-drug conjugate Enhertu has already paid off with a big approval in breast cancer more than a year ago. But the partners have big plans for their blockbuster in the making, and a new nod in gastric cancer will raise their spirits even higher.

The FDA on Friday approved Enhertu to treat locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in patients who have previously undergone at least one round of treatment with a Herceptin-based regimen, AstraZeneca said in a release.