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.

Nearly three years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys’ Monjuvi, or tafasitamab-cxix, was cleared Friday for use in refractory diffuse large B-cell lymphoma (DBLCL). The approval sets up both MorphoSys and their commercial partner Incyte to compete with Gilead and Novartis in the ultra-competitive indication, where similar trial results and far easier delivery could allow them to cut a fair share of the market.

DBV Technologies’ long and winding saga with the FDA has ended — for now, at least — with a CRL for their peanut allergy skin patch.

The rejection comes 21 months after the company first filed for approval. At the time, the French biotech was in a two-way race with California’s Aimmune to produce the first FDA-approved treatment for peanut allergy. But since then Aimmune cleared that hurdle, while DBV, after a withdrawal and resubmission, indicated that communication between them and regulators had broken down.  In June, the company began cutting programs and employees.

Eli Lilly and the NIH are about to start a first-of-its-kind trial that researchers and developers have talked about for months as a way of providing temporary immunity to the most at-risk populations.

Lilly announced this morning that it will start a 2,400-person trial with the National Institute for Allergy and Infectious Diseases to test whether its experimental Covid-19 neutralizing antibody can prevent people in nursing homes and assisted living facilities from developing the disease. The idea, known as passive immunity, is that rather than waiting on a vaccine to induce people to develop antibodies, doctors can give them lab-grown antibodies. Ideally, those antibodies will either attack the new SARS-CoV-2 infection, if the patient has recently been exposed, or persist in the blood for several weeks and prevent infection or disease for that period.