The ven­ture in­vestors at Medicxi are fund­ing a pair of biotech spin­outs from UK-based So­sei Hep­tares, which has been fine tun­ing its ex­per­tise in G pro­tein-cou­pled re­cep­tors for a num­ber of years now.

Francesco De Ru­ber­tis

Medicxi is of­fer­ing €40 mil­lion to kick­start two new com­pa­nies — the twins Orex­ia and In­ex­ia, which will tar­get Orex­in OX1 and OX2 for neu­ro­log­i­cal dis­eases. The Hep­tares sub­sidiary will put its re­searchers to work on the two projects, iden­ti­fy­ing nar­colep­sy as one key dis­ease on the menu.

Orex­ins are well known tar­gets in the biotech world. These neu­ropep­tides are in­volved in the reg­u­la­tion of sleep, wake­ful­ness and ap­petite.

Mal­colm Weir

Medicxi part­ner Francesco De Ru­ber­tis will sit on the board to watch over the firm’s in­vest­ment. Both of these groups have deep roots in the UK, with So­sei look­ing to build up the Hep­tares op­er­a­tion un­der Mal­colm Weir.

The VC’s cash should be enough to get through proof-of-con­cept stud­ies, fit­ting neat­ly in Medicxi’s as­set-cen­tric fo­cus, which of­ten fo­cus­es the mon­ey on ear­ly-stage re­search pro­grams stripped of as much over­head as they can.

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.