An­oth­er day, an­oth­er de­lay. On Mon­day, Roche re­vealed that in ad­di­tion to the US Fed­er­al Trade Com­mis­sion, the UK’s Com­pe­ti­tion and Mar­kets Au­thor­i­ty is prob­ing the Spark Ther­a­peu­tics takeover deal, trig­ger­ing an­oth­er de­lay of the $4.3 bil­lion ac­qui­si­tion an­nounced in Feb­ru­ary.

Spark share­hold­ers now have un­til Ju­ly 31 to ten­der their shares.

Since its last up­date in mid-May, the per­cent­age of shares al­ready sold inched up to 21.1% from 21%, low­er than 26.1% and 29.4% reg­is­tered on pre­vi­ous dead­lines. These num­bers are still a far cry from the 50% re­quired to con­sum­mate the deal, but Roche has main­tained it’s not un­usu­al for “a sig­nif­i­cant por­tion of share­hold­ers” to wait un­til the last days of the of­fer pe­ri­od.

“We think this is ap­pro­pri­ate dili­gence by FTC but there is un­like­ly any ma­jor is­sue and the deal will close smooth­ly,” Jef­feries an­a­lysts wrote in a note, not­ing that he­mo­phil­ia mar­ket is crowd­ed and that the way a gene ther­a­py is en­gi­neered to work is a stark con­trast to Roche’s ex­ist­ing Hem­li­bra he­mo­phil­ia drug.

“If any­thing, the reg­u­la­tors should see the nu­mer­ous com­peti­tors as pos­i­tive for the mar­ket dy­nam­ics where­by price could po­ten­tial­ly come way down over time and all the play­ers will have to bat­tle for pa­tients (sim­i­lar to Hep C mar­ket in that re­spect)…For these fun­da­men­tal im­por­tant rea­sons, we don’t see how this will be an an­ti-com­pet­i­tive merg­er and un­der­stand the reg­u­la­tors are think­ing about it in the long-term,” they wrote.

Roche’s orig­i­nal dead­line for the deal clos­ing was set for the first half of 2019. “(I)t is un­like­ly that the trans­ac­tion will close dur­ing the first half of 2019. The par­ties ex­pect the trans­ac­tion to close in 2019,” a Roche spokesper­son tells End­points News.

Mean­while the UK’s CMA has al­so opened an in­ves­ti­ga­tion in­to the pro­posed takeover to de­ter­mine whether the deal could hurt com­pe­ti­tion in the UK. Pend­ing the out­come of its in­ves­ti­ga­tion, the CMA has is­sued an in­ter­im en­force­ment or­der  which pre­cludes Roche from in­te­grat­ing Spark in­to the com­pa­ny, and stip­u­lates the two main­tain and op­er­ate the two busi­ness­es sep­a­rate­ly — for now. Both firms are co­op­er­at­ing with the CMA, they said on Mon­day.

“The is­suance of an IEO does not of it­self mean that the CMA has sub­stan­tive con­cerns about the ac­qui­si­tion nor that the CMA has the le­gal pow­er to in­ter­vene to im­pose con­di­tions to the ac­qui­si­tion pro­ceed­ing,” the spokesper­son added.

Spark’s in­vestors ex­pressed their frus­tra­tion with the lat­est de­lay, as the com­pa­ny’s shares $ONCE tum­bled about 9% to $99.80 in ear­ly morn­ing trad­ing.

In a Feb­ru­ary Q&A doc­u­ment in­tend­ed to pla­cate em­ploy­ees, Spark sug­gest­ed that Roche in­tend­ed to al­low the Philadel­phia-based com­pa­ny to op­er­ate as an au­tonomous gene ther­a­py spe­cial­ist, while pour­ing in the re­sources to build a whole unit around it.

Im­age: Spark CEO Jef­frey Mar­raz­zo at an End­points News break­fast pan­el at the 2019 JP Mor­gan con­fer­ence in San Fran­cis­co – pho­to by Jeff Ru­mans for End­points News

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Magenta Therapeutics is pausing an early-stage clinical trial after a patient died. The death was deemed to be possibly related to its drug, MGTA-117.

The biotech said the pause of the Phase I/II trial is voluntary and gives it time to review all available data before deciding what to do next. It’s also reported the known information to the FDA.

The dose-escalation trial was designed to test whether MGTA-117, an antibody-drug conjugate, could serve as a more targeted alternative to high-intensity chemotherapy as a conditioning agent for cancer patients who are set to receive a stem cell transplant. It recruited patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.

Regeneron has won a patent case against Swiss pharma giant Novartis over the delivery system for its eye drug Eylea.

The US Patent Trial and Appeal Board ruled that Novartis’ pre-filled syringe for injecting its eye medication Lucentis was “unpatentable” and handed the victory to Regeneron and its AMD drug Eylea.

In the initial complaint in 2020, Novartis alleged to the US International Trade Commission that certain pre-filled syringes for the intravitreal injection, and ultimately Regeneron’s delivery system for Eylea, were infringing on Novartis’ patent. Regeneron filed a petition to review Novartis’ claims in 2021.