It’s start­ing to feel like Te­va $TE­VA can’t catch a break. Af­ter an in­cred­i­bly rough se­ries of events that led to mas­sive lay­offs, re­struc­tur­ing, and po­lit­i­cal up­heaval, now Te­va has qui­et­ly sig­naled to in­vestors that the launch of its CGRP mi­graine med could be de­layed.

Te­va’s stock has tum­bled near­ly 10% in pre-mar­ket trad­ing on the news.

Te­va’s drug, called fre­manezum­ab (TEV-48125), came up with some im­pres­sive Phase III da­ta last fall, with 41% of pa­tients on their CGRP drug see­ing their mi­graine days cut in half, com­pared to 18% on the place­bo. The dou­ble blast of da­ta un­der­scores the late-stage race to reg­u­la­tors as some big and small play­ers an­gle for a slice of the new CGRP mi­graine mar­ket.

But now, fre­manezum­ab may hit a stum­bling block. Te­va’s part­ner Cell­tri­on, which man­u­fac­tures an ac­tive in­gre­di­ent in fre­manezum­ab, re­ceived a warn­ing let­ter from the FDA rais­ing is­sues over a man­u­fac­tur­ing fa­cil­i­ty in In­cheon, South Ko­rea.

The slow­down couldn’t come at a worse time for the com­pa­ny, as ri­vals Am­gen $AMGN and its part­ner No­var­tis $NVS were al­ready in the lead to com­mer­cial­ize their own CGRP mi­graine drug, Aimovig. The FDA has al­ready ac­cept­ed Am­gen’s ap­pli­ca­tion for Aimovig — hand­ing the com­pa­ny a PDU­FA date of May 17.

The CGRP field is grow­ing hot, with a line­up of de­vel­op­ers po­si­tion­ing their own late-stage prod­ucts for the last leg of the race.

Ear­li­er this year, Eli Lil­ly $LLY cel­e­brat­ed its Phase III re­sults for gal­canezum­ab, with a con­sis­tent 2-day re­duc­tion in month­ly mi­graines. And Al­ler­gan $AGN has a late-stage pro­gram un­der­way for an oral CGRP ther­a­py it in-li­censed from Mer­ck in 2015 with a $250 mil­lion up­front. Lit­tle Alder $AL­DR is plan­ning to join the com­mer­cial fight with their drug, as well. Then there’s Bio­haven $BHVN, which re­cent­ly in-li­censed a sim­i­lar drug from Bris­tol-My­ers Squibb and scored a very suc­cess­ful IPO ear­li­er this year.

Te­va not­ed the warn­ing let­ter on a slide for in­vestors, and said the com­pa­ny was “in ac­tive di­a­logue with the FDA in an ef­fort to main­tain our pri­or­i­ty date for the ap­proval.”

Typ­i­cal­ly takes 16-18 months to re­solve an FDA warn­ing let­ter, $TE­VA says. Com­pa­ny planned to have two API sup­pli­ers but the sec­ond sup­pli­er isn’t ready yet, Schultz says

— Em­ma Court (@em­mar­court) Feb­ru­ary 8, 2018

CEO Schultz says $TE­VA is hop­ing to work with FDA on franezum­ab CGRP ap­pli­ca­tion be­cause Cell­tri­on warn­ing let­ter was for fin­ished prod­ucts, not API. A sec­ond API sup­pli­er is in the works but not ready to go. Good news for ri­val $NVS

— Jes­si­ca Mer­rill (@Jes­si­cae­mer­rill) Feb­ru­ary 8, 2018

With little explanation for why Merck’s potential Covid-19 antiviral was less effective in reducing Covid hospitalizations and deaths in a full analysis of a Phase 3 trial versus an interim look, the FDA’s antimicrobial drugs advisory committee on Tuesday voted 13-10 in favor of the pill’s benefits outweighing the risks for adults within 5 days of developing Covid symptoms.

Molnupiravir will likely be authorized by FDA in the coming days for adults with mild or moderate Covid-19. While Pfizer’s antiviral may prove to be more effective, Merck’s pill will be another weapon in the armamentarium of Covid-19 treatments for countries around the world, adding to the mAb treatments already in use in the outpatient space from Regeneron, Eli Lilly and Vir/GlaxoSmithKline.

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After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.