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

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.

→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.

The Trump administration is not giving up just yet. On Wednesday, the HHS filed an appeal against a judge’s decision in July to overturn a ruling obligating drug manufacturers to disclose the list price of their therapies in television adverts — hours before it was stipulated to go into effect.

In May, the HHS published a final ruling requiring drugmakers to divulge the wholesale acquisition cost— of a 30-day supply of the drug — in tv ads in a bid to enhance price transparency in the United States. The pharmaceutical industry has vehemently opposed the rule, asserting that list prices are not what a typical patient in the United States pays for treatment — that number is typically determined by the type of (or lack thereof) insurance coverage, deductibles and out-of-pocket costs. Although there is truth to that claim, the move was considered symbolic in the Trump administration’s healthcare agenda to hold drugmakers accountable in a climate where skyrocketing drug prices have incensed Americans on both sides of the aisle.

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll