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

Zo­genix shares are claw­ing back some of the val­ue they lost 2 months ago af­ter the FDA hit the biotech with a refuse-to-file no­tice on their ex­per­i­men­tal ther­a­py for Dravet syn­drome. 

Com­pa­ny ex­ecs said this morn­ing that they worked out reg­u­la­tors’  is­sues with the ap­pli­ca­tion for Fin­tepla, which cen­tered on a pair of big prob­lems: the ab­sence of non-clin­i­cal stud­ies need­ed to al­low as­sess­ment of the chron­ic ad­min­is­tra­tion of fen­flu­ramine and the in­clu­sion of an in­cor­rect ver­sion of a clin­i­cal dataset. Now they plan to re­sub­mit in Q3 af­ter get­ting off the hook on both scores — which trig­gered a sigh of re­lief among in­vestors.

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

Re­gen­eron and their part­ners at Sanofi have beat the No­var­tis/Roche team to the punch on an­oth­er key in­di­ca­tion for their block­buster an­ti-in­flam­ma­to­ry drug Dupix­ent. The drug team scored an ac­cel­er­at­ed FDA ap­proval for chron­ic rhi­nos­i­nusi­tis with nasal polyps, mak­ing this the first such NDA for the field.

An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.