With a full slate of in­jectable CGRP mi­graine drugs po­si­tion­ing them­selves at the fin­ish line for FDA ap­provals for chron­ic cas­es, Al­ler­gan $AGN to­day took an­oth­er big step for­ward with its pill for acute cas­es. The com­pa­ny hailed a Phase III win for its first late-stage test of ubro­gepant, one of the mi­graine drugs it ac­quired from Mer­ck a lit­tle more than two years ago.

Re­searchers say the drug hit both of the co-pri­ma­ry end­points for acute mi­graine, with a sta­tis­ti­cal­ly sig­nif­i­cant beat for a place­bo arm in be­ing pain free and free of most symp­toms of mi­graine two hours af­ter ini­tial treat­ment.

David Nichol­son, Al­ler­gan

Al­ler­gan plans to pub­lish more of the da­ta lat­er in the year, with the sec­ond Phase III read­out com­ing in the first half of 2018. Al­ler­gan ex­ecs in turn ex­pect that will set up an NDA for next year.

Mean­while, Am­gen and No­var­tis are in the lead on the in­jectable side of the CGRP race, with the FDA re­view­ing their drug, Aimovig. The drug will like­ly be chal­lenged by a group of com­peti­tors rang­ing from Eli Lil­ly $LLY to Te­va $TE­VA and Alder $AL­DR that have all demon­strat­ed broad­ly sig­nif­i­cant da­ta in cut­ting the num­ber of mi­graine days ex­pe­ri­enced by a chron­ic suf­fer­er.

Com­mit­ted to in­no­va­tion in #mi­graine treat­ments. @Al­ler­gan An­nounces Pos­i­tive Top Line Phase 3 Re­sults for Ubro­gepant – an Oral CGRP Re­cep­tor An­tag­o­nist for the Acute Treat­ment of Mi­graine https://t.co/ytP2W1CpW5

— Brent Saun­ders (@brentl­saun­ders) Feb­ru­ary 6, 2018

“We are pleased with the fa­vor­able re­sults of our ACHIEVE I study, which sup­port the ef­fi­ca­cy, safe­ty, and tol­er­a­bil­i­ty pro­file of ubro­gepant. We are con­fi­dent that ubro­gepant, an oral cal­ci­tonin gene-re­lat­ed pep­tide (CGRP) re­cep­tor an­tag­o­nist will be an op­tion for the treat­ment of mi­graines in adults,” said David Nichol­son, Al­ler­gan’s head of R&D. “Al­ler­gan re­mains com­mit­ted to iden­ti­fy­ing, de­vel­op­ing and bring­ing to mar­ket ther­a­pies that ad­dress un­met need for pa­tients suf­fer­ing from this de­bil­i­tat­ing dis­ease.”

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Months after taking the helm at Verastem Oncology, Brian Stuglik has a plan to take the biotech in a “new strategic direction” — but not before some layoffs.

Left out of an upbeat press release spelling out its clinical plans, and buried below news of a $100 million private placement in an SEC filing, is a planned restructuring that will claim 31 jobs. Alongside some other cost-saving measures, Verastem expects to cut expenses down by $70 million to $80 million per year.

Former Sanofi chief Olivier Brandicourt, who departed his post with an unexpected early retirement last year, has made his move — as most C-suite executives inevitably do — to become a director on the board of a biopharma company.

RNAi player Alnylam is Brandicourt’s destination. Meanwhile, the Cambridge, Massachusetts-based drugmaker — which pioneered the first approval in the field — also disclosed the retirement of Alnylam co-founder Dr. Paul Schimmel from its board.

A coronavirus fear-induced bloodbath on the Nasdaq has not stopped Passage Bio from making a public debut — and an exuberant one.

By pricing an upsized offering at $18, the top of the range, the gene therapy biotech bagged $216 million from its IPO, 72% more than it’s originally penciled in.

The proceeds likely reflected confidence in Jim Wilson, who gathered all the tools he’s built over decades of gene therapy research to assemble the startup and teamed up with Frazier and OrbiMed to hone its focus on rare, monogenic disorders of the central nervous system. Just before the IPO, Deerfield partner Bruce Goldsmith took over from OrbiMed’s Stephen Squinto as CEO.