Roche CEO Sev­erin Schwan may have pre­pared the staff at Spark for the fifth de­lay of its $4.3 bil­lion ac­qui­si­tion — adding a few months of cush­ion and push­ing the dead­line as far as April 30, 2020 — but that’s not stop­ping an­a­lysts from be­com­ing se­ri­ous­ly con­cerned.

Sev­erin Schwan Roche

The FTC’s dragged on in­ves­ti­ga­tion, which is hold­ing up the deal, points to some­thing big­ger than Spark or Roche, Mani Foroohar of SVB Leerink told Bloomberg. It sends a wor­ry­ing sig­nal to any buy­ers look­ing to make a move in gene ther­a­py M&A.

“For any­one try­ing to make that deal there’s a par­a­lyz­ing ef­fect,” Foroohar said in an in­ter­view with the news out­let. “What would’ve been seen as a low ex­e­cu­tion risk, low reg­u­la­to­ry risk, straight­for­ward deal is sud­den­ly some­thing caught up for a year and a half, and you have to look at di­vest­ing,” he said.

The group of po­ten­tial takeover tar­gets in­cludes uniQure and Bio­Marin, both of which have late-stage gene ther­a­py pro­grams lined up.

Gene ther­a­pies for he­mo­phil­ia, too. While ex­ecs and reg­u­la­tors have re­peat­ed­ly de­clined to shed light on the road­block, a com­mon as­sump­tion is that the FTC is prob­ing for po­ten­tial over­laps be­tween Spark’s ex­per­i­men­tal he­mo­phil­ia treat­ments and Roche’s new­ly launched Hem­li­bra. More re­cent­ly, the UK’s Com­pe­ti­tion and Mar­kets Au­thor­i­ty has al­so launched its own in­ves­ti­ga­tion.

Jef­feries an­a­lysts con­tend­ed that “there is un­like­ly any ma­jor is­sue” as the he­mo­phil­ia mar­ket is crowd­ed and gene ther­a­pies work quite dif­fer­ent­ly than Hem­li­bra, an an­ti­body that bridges two oth­er blood clot­ting fac­tors.

Hav­ing con­fi­dent­ly pre­dict­ed that the deal would close in the first half of this year, Roche is now look­ing to wrap it by year-end. Spark stock­hold­ers — which have col­lec­tive­ly ten­dered 25.2% of their shares — now have un­til Sep­tem­ber 3 to pon­der if there will be yet an­oth­er ex­ten­sion.

A couple years after licensing Novimmune’s emapalumab and turning around a quick FDA OK, Stockholm-based Sobi is betting up to $1.2 billion for rights to another rare disease drug.

The company is shelling out $250 million upfront and adding up to $915 million in milestones for rights to develop and commercialize Apellis Pharmaceuticals’ drug pegcetacoplan outside the US. Together, the companies will see the systemic C3 therapy through five registrational trials in hematology, nephrology and neurology.

The last four years have seen a sudden explosion in treatments for spinal muscular atrophy, a neurodegenerative condition that once led patients — often young ones — with a grim prognosis and no options. The prognosis still isn’t rosy, but now there are three FDA-approved options, enough to make the choice of one difficult.

Now a fourth potential option has entered the mix. Today, Scholar Rock announced the results from a proof-of-concept testing their SMA drug by itself and in combination with Ionis’ Spinraza, showing that all patient cohorts improved on standard scales used for measuring motor function in people with SMA.

Illumina is going to have a lot of work to do to prove Grail was worth those $8 billion.

Today, Exact Sciences announced that it will acquire Thrive, Grail’s chief rival among the early cancer detection startups, for a sizeable but relatively moderate $2.15 billion. The yawning gap in part reflects the vast differences in capital that have been invested to date in each company.  But both have gone toe-to-toe over the last year and a half, with Grail having published data in over 50 cancers but Thrive recently beating them to a key test for liquid biopsy companies.

EQRx is paying top dollar to bring a pair of PD-(L)1 drugs into its portfolio of fast-follow therapies, offering $150 million upfront in what could shape up to be a $1.3 billion alliance with China’s CStone.

As early as 2017 Celgene had bet on a made-in-China PD-1 via its pact with BeiGene, quickly followed by Arcus as the second checkpoint wave was looming; more recently Eli Lilly imported longtime partner Innovent’s PD-1 in a $1 billion deal. All are diving into a space now dominated by Merck’s Keytruda franchise, where six other players are trying to catch up by carving out their own niches — and more are on their way to tap into the various I/O pairings anchored by a PD-(L)1. But none so far has quite shared EQRx’s explicit mission to disrupt the multibillion-dollar market by offering a lower cost option.

Two weeks after the safety data monitoring group advised researchers to hit the hold button on a clinical trial of Eli Lilly’s antibody bamlanivimab (LYCoV55) for patients hospitalized with Covid-19, the trial overseers are back with fresh directions to shutter the study after losing faith that the drug could help this group of patients.

The monitors concluded, however, that there were no safety issues involved, which will likely encourage continued belief that Lilly can still nail down an emergency marketing application for less-sick patients.