→ A herd of up­start biotechs will look to Wall Street for some ma­jor wind­falls this week as a burst of new of­fer­ings con­tin­ues to feed cash in­to the R&D sys­tem. To­day we learned that Bridge­Bio will look to raise in the neigh­bor­hood of $225 mil­lion by of­fer­ing 15 mil­lion shares for $14 to $16 each. And they have a string of joint bookrun­ners: J.P. Mor­gan, Gold­man Sachs, Jef­feries, SVB Leerink, KKR, Piper Jaf­fray, Mizuho Se­cu­ri­ties, BMO Cap­i­tal Mar­kets and Ray­mond James. If suc­cess­ful, Bridge­Bio will emerge with a mar­ket cap of around $1.7 bil­lion. There are 5 biotechs look­ing to IPO this week, in­clud­ing Akero and Pre­vail.

→ Rockville, MD-based CASI Phar­ma­ceu­ti­cals has in-li­censed an an­ti-CD19 T cell ther­a­py from Chi­na’s Ju­ven­tas. CASI is mak­ing an $11.6 mil­lion in­vest­ment in Ju­ven­tas in lieu of an up­front pay­ment. They’ll joint­ly con­tin­ue the de­vel­op­ment work.

→ Flex Phar­ma is hav­ing a lit­tle bit of trou­ble in ex­e­cut­ing its re­verse merg­er deal with Salarius Phar­ma­ceu­ti­cals. The failed biotech $FLKS says it needs to see more votes cast by share­hold­ers af­ter fail­ing to achieve a quo­rum — in per­son or proxy — at a spe­cial meet­ing. Its be­lea­guered shares dropped 24% to a mere 49 cents in pre-mar­ket trad­ing on Mon­day.

→ Ar­bu­tus Bio­phar­ma tapped William Col­lier as its next pres­i­dent and CEO. Col­lier suc­ceeds Mark Mur­ray, who is re­tir­ing on June 23. Col­lier has had over 30 years of ex­pe­ri­ence in the phar­ma­ceu­ti­cal in­dus­try. He served as pres­i­dent and gen­er­al man­ag­er, North Amer­i­ca at Vi­iV Health­care, in ad­di­tion to a stint at GSK $GSK as well. 

→ Med­ical ge­net­ics com­pa­ny, In­vi­tae Cor­po­ra­tion, is set to ac­quire Sin­gu­lar Bio to help in­crease ac­cess to ge­net­ic screen­ing in ear­ly preg­nan­cy. Sin­gu­lar Bio is “a pri­vate­ly held com­pa­ny de­vel­op­ing sin­gle mol­e­cule de­tec­tion tech­nol­o­gy that en­ables low­er costs and ex­pand­ed use of high-qual­i­ty, cell-free nu­cle­ic acid analy­sis, ini­tial­ly for ap­pli­ca­tion in non-in­va­sive pre­na­tal screen­ing (NIPS).”

→ In­cyte $IN­CY on Sat­ur­day pre­sent­ed 24-week re­sults from a mid-stage study of its JAK in­hibitor rux­oli­tinib, which showed the drug met the main goal of in­duc­ing ≥50% im­prove­ment in the fa­cial vi­tili­go. “This 24-week in­ter­val was the first part of a 3-part, 104-week study, and await 52- and 104-week da­ta to con­firm the safe­ty and ef­fi­ca­cy seen this week­end,” Cred­it Su­isse an­a­lysts wrote in a note. 

→ Calithera $CALA on Mon­day broke out da­ta from a mid-stage study test­ing its glu­t­a­m­i­nase in­hibitor, tela­gle­na­s­tat, in com­bi­na­tion with chemother­a­py everolimus. The tela­gle­na­s­tat com­bi­na­tion achieved a  me­di­an pro­gres­sion-free sur­vival (mPFS) of 3.8 months, while everolimus-treat­ed pa­tients ex­pe­ri­enced mPFS of 1.9 months. “While the top-line da­ta are en­cour­ag­ing, they do ap­pear to have de­te­ri­o­rat­ed vs. ear­li­er Phase I re­sults,” SVB Leerink an­a­lysts wrote in a note. 

→ A 15-month long sweep­ing in­ter­nal in­ves­ti­ga­tion en­com­pass­ing more than a mil­lion doc­u­ments, thou­sands of hours of se­cret video sur­veil­lance — in­stalled un­der the aus­pices of for­mer CEO Park­er “Pe­te” Pe­tit — and over 80 wit­ness­es, paint­ed a sor­did pic­ture of the scan­dalous past of the wound care com­pa­ny MiMedx in May. Ear­li­er this month, MiMedx begged its share­hold­ers not to fall for ma­ligned Pe­tit’s bid to re­turn to the com­pa­ny’s board, along with two of his busi­ness as­so­ciates. A pre­lim­i­nary vote count sug­gests stock­hold­ers have lis­tened, the com­pa­ny said on Mon­day.

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

Seven years after spinning out of Yale, Biohaven has entered the ranks of commercial-stage biotechs.

The FDA handed down an OK for its CGRP drug, rimegepant, as an acute treatment. Dubbed Nurtec, the orally dissolving pill will join Allergan’s (soon to be AbbVie’s) Ubrelvy and Lilly’s Reyvow on the market amid a new wave of migraine therapies reshaping the disease space.

In a pivotal Phase III trial, Nurtec hit the co-primary endpoints on pain freedom and freedom from most bothersome symptoms at two hours post dose, proving superior to placebo.