Six days af­ter Genen­tech rolled out dis­ap­point­ing ear­ly-stage da­ta on its IDO1 drug GDC-0919 (navox­i­mod) in-li­censed from NewLink Ge­net­ics, the big Roche sub­sidiary is kick­ing it out of the pipeline.

NewLink $NLNK an­nounced that Genen­tech has hand­ed back all rights to the drug, though its dis­cov­ery part­ner­ship con­tin­ues. The can­cer drug spe­cial­ist is walk­ing away from a $1 bil­lion-plus deal that was inked with $150 mil­lion up­front.

NewLink’s shares cratered once again on the news, falling 31% by mid-morn­ing.

This is the lat­est in a se­ries of gut punch­es to NewLink, which was sent reel­ing last year and was forced to re­struc­ture in the wake of the fail­ure of its pan­cre­at­ic can­cer vac­cine. IDO, a hot tick­et in biotech now with In­cyte $IN­CY ev­i­dent­ly well in the lead, was sup­posed to be its path back.

The writ­ing, though, was on the wall when in­ves­ti­ga­tors re­port­ed that GDC-0919 de­liv­ered on­ly a 10% over­all re­sponse rate in all tu­mor types in a com­bi­na­tion study with Tecen­triq — a PD-L1 check­point that is al­so un­der a cloud since the big Phase III fail­ure in blad­der can­cer. Genen­tech is not known for pur­su­ing fu­tile work in can­cer.

NewLink was al­so forced to con­cede 6 days ago that its in-house IDO in­hibitor in­dox­i­mod failed a Phase II study for breast can­cer, mak­ing this a very bad, no good, aw­ful week for the biotech.

Charles Link Jr.

“We are ob­vi­ous­ly dis­ap­point­ed in this de­ci­sion,” said Charles J. Link, Jr., CEO of NewLink Ge­net­ics, in a state­ment. “We re­main com­mit­ted to ad­vanc­ing our IDO path­way in­hibitor in­dox­i­mod, which con­tin­ues to gen­er­ate ex­cit­ing da­ta in com­bi­na­tion with an­ti-PD-1 agents, can­cer vac­cines, and chemother­a­py in mul­ti­ple can­cer types in­clud­ing melanoma, prostate can­cer, acute myeloid leukemia, and pan­cre­at­ic can­cer.”

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.

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

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.