ALETH / LIFESCI-BRIEF / 2026-08-14 / US OVERHAULS CHILDHOOD VACCINESThe Aleth Briefs trace each story to its original source and show how the week unfolded.
The week in five lines:
The White House ordered an overhaul of US childhood vaccination schedules.
The FDA proposed 50% fee cuts for US-run trials.
Jazz and Actio agreed a $1.3bn rare-epilepsy deal.
Sionna dropped SION-719 after a phase 2 miss.
Definium’s LSD pill cleared a second phase 3.
Browse by day:
Weekend catch-up: WuXi ruling
Monday: US vaccines · Jazz-Actio · Sionna · UK Foundayo · MoonLake · Sobi-Innate
Tuesday: Autolus · Vaderis · Vykat XR
Wednesday: Definium · Cullinan-Taiho · MMR pushback · Sangamo auction
Thursday: US user fees · Tavneos
Weekend catch-up
A US federal judge blocked the Pentagon from enforcing WuXi AppTec’s designation as a Chinese military company.
A US District Court granted a preliminary injunction barring the Department of Defense from effecting the Section 1260H listing while WuXi’s challenge runs, finding the company likely to show the designation was arbitrary and capricious. WuXi had documented clients cancelling and moving work to rivals since the June listing.
WuXi AppTec Co., Ltd. v. US Department of Defense, 1:26-cv-02069 · CourtListener
Judge blocks listing of WuXi AppTec as ‘Chinese military’ · Pharma Manufacturing
Monday 10 August
The White House ordered a rewrite of US childhood vaccine schedules.
The executive order, “Delivering Gold Standard Childhood Vaccine Recommendations for Americans”, cuts the universally recommended childhood vaccinations from 17 to 11, moves shots including hepatitis B, rotavirus, influenza and COVID-19 to high-risk or shared decision-making categories, and directs that the MMR vaccine be given as three separate shots once single-disease versions exist in the US.
Gold standard childhood vaccine recommendations for Americans · White House
Jazz agreed to buy Actio Biosciences for up to $1.32bn.
Jazz Pharmaceuticals will pay $820m upfront and up to $500m in contingent consideration for the private biotech, whose lead asset ABS-1230 is a potential first-in-class KCNT1 ion channel inhibitor for a rare genetic epilepsy affecting 2,500 in the US. The deal extends the epilepsy business built on Epidiolex (cannabidiol, GW Pharma).
Acquiring Actio Biosciences, expanding rare epilepsy portfolio · Jazz Pharmaceuticals
Sionna’s cystic fibrosis add-on failed.
In the phase 2a PreciSION CF trial, SION-719 added to Trikafta shifted sweat chloride by a placebo-adjusted -1.0 mmol/L (p=0.7). Sionna Therapeutics will not take the NBD1 stabiliser forward as an add-on to standard of care. Sionna named SION-451 plus SION-2222 as its preferred pairing while it weighs next steps.
Topline data from two development programs in CF · Sionna Therapeutics
The MHRA authorised Lilly’s orforglipron, the first regulator in Europe to clear it.
Foundayo (orforglipron) is authorised for weight loss in adults with obesity or overweight plus a comorbidity, and separately for inadequately controlled type 2 diabetes. It is the second oral GLP-1 cleared for weight loss in the UK in two months, after Novo Nordisk’s oral Wegovy in June. NHS use will require NICE evaluation first.
UK first in Europe to authorise orforglipron for weight loss and diabetes · MHRA
MoonLake’s sonelokimab met its endpoints in first phase 3 in psoriatic arthritis.
In IZAR-1, 42.1% of biologic-naive patients on the nanobody’s 60 mg induction regimen reached ACR50, with wins across key secondary endpoints and no new safety signals. The trial runs to week 52, reading out fully in H1 2027; IZAR-2, in TNF-inadequate responders with a Skyrizi reference arm, completes enrolment in Q3 2026.
Positive topline results phase 3 of sonelokimab · MoonLake Immunotherapeutics
Sobi licensed Innate Pharma’s lacutamab in a deal worth up to $580m.
Sobi pays $75m at closing for global rights to commercialise the anti-KIR3DL2 antibody on any accelerated approval in Sézary syndrome, with up to $40m in near-term milestones and up to $465m tied to an option over full development rights.
Partnership with Innate Pharma to license lacutamab in T-cell lymphoma · Sobi
The FDA rejected ITM’s radiopharmaceutical over manufacturing issues.
The complete response letter for 177Lu-edotreotide (ITM-11) in gastroenteropancreatic neuroendocrine tumours rests on chemistry, manufacturing and controls (CMC) deficiencies and unresolved conditions at a third-party facility. It raised no clinical or safety concerns and asks for no new trials. The phase 3 COMPETE trial had beaten everolimus on progression-free survival. ITM intends to resubmit.
ITM Receives Complete Response Letter for 177Lu-edotreotide (ITM-11) · ITM
Revolution Medicines and BeOne Medicines agreed a RAS collaboration.
BeOne takes exclusive rights to Revolution’s four clinical RAS(ON) inhibitors in selected Asian markets ex-Japan and South Korea and will fund a global registrational phase 3. The pair will also test combinations pairing daraxonrasib and zoldonrasib with BeOne’s PRMT5 inhibitor and its EGFR x MET x MET trispecific antibody.
BeOne clinical and regional commercialization collaboration · Revolution Medicines
Silence Therapeutics’ divesiran hit in phase 2 and it priced a $175m offering.
In the 48-patient SANRECO polycythaemia vera trial, 88% on the siRNA responded against 19% on placebo, while phlebotomies fell to 0.2 against 2.1 (per pt, p<0.0001). Phase 3 starts H1’27. Silence priced an upsized $175m offering at $13.50 the next day.
AbCellera’s mAb cut hot flushes 83% in phase 2 and it priced a $200m offering.
A single 600 mg dose of ABCL635 cut daily moderate-to-severe hot flushes by 83% reduction against 33% placebo, with no serious adverse events among 92 postmenopausal women. AbCellera priced an oversubscribed $200m offering at $9.75.
Quanterix cut its 2026 revenue guidance by 15% and its shares fell about 40%.
Q2 revenue of $32.9m came in 9% below the company’s own May guidance, with pro forma revenue down 23% YoY, and the full-year range falls to $142m-$148m from $169m-$174m on weak academic and government demand and execution challenges.
Quanterix releases financial results for the second quarter of 2026 · Quanterix
Tuesday 11 August
Autolus confirmed Q2 Aucatzyl revenue of $45.7m, up 119% YoY.
Q2 net revenue for Aucatzyl reached $45.7m, up 119% YoY, taking H1 to $71.9m; the London-based company guides 2026 sales of $140-$150m. Enrolment continues in lupus nephritis, paediatric acute lymphoblastic leukaemia and multiple sclerosis.
Second quarter 2026 financial results and business updates · Autolus Therapeutics
Vaderis raised a $152m series B and started a phase 3 in a rare vascular disorder.
The Swiss biotech’s engasertib, an oral allosteric AKT inhibitor, enters the global phase 3 HEROIC study in hereditary haemorrhagic telangiectasia, which has no approved treatment anywhere. Goldman Sachs Alternatives and TCGX co-led the round.
Oversubscribed $152m Series B financing & Phase 3 study · Vaderis Therapeutics
Prader-Willi organisations flagged serious adverse events reported on Neurocrine’s Vykat XR.
A joint statement from PWSA USA, the Foundation for Prader-Willi Research and IPWSO urges careful patient selection and monitoring after post-marketing reports of oedema, respiratory and cardiac complications. Fierce Pharma reported seven deaths and >100 serious adverse events in the FDA’s adverse event system. Neurocrine, which took on Vykat XR (diazoxide choline) in its $2.9bn Soleno purchase, says the drug has “a compelling risk-benefit profile in the context of a very serious disease.”
PWS organizations share joint statement on VYKAT XR adverse events · PWSA USA
Neurocrine stands by blockbuster hopeful as docs raise safety flags · Fierce Pharma
Wednesday 12 August
Definium’s LSD pill cleared its second phase 3.
In the Voyage trial in generalised anxiety disorder, DT120 (lysergide) 100 µg cut the Hamilton Anxiety score by 11.6 points against 6.2 on placebo at week 12 (p<0.0001). It is the second positive phase 3 for the orally disintegrating tablet after June’s Emerge readout in major depression. The FDA has granted breakthrough therapy designation in anxiety. A second trial, Panorama, reads out in September.
Topline results from Phase 3 Voyage study of DT120 ODT · Definium Therapeutics
Taiho and Cullinan’s zipalertinib met its phase 3 goal in first-line lung cancer.
In a planned interim analysis of the 285-patient REZILIENT3 trial, the EGFR inhibitor plus chemotherapy improved progression-free survival in untreated EGFR exon 20 insertion non-small cell lung cancer. Pending FDA discussions, the partners plan to pursue US approval, which would take the drug into Rybrevant’s (J&J) territory.
Zipalertinib meets primary endpoint of PFS in Phase 3 REZILIENT3 · Taiho Oncology
Merck and GSK pushed back on splitting the MMR vaccine.
Both makers of the US combination shot told Reuters there is no published evidence to support separating it, and neither set out plans to. Merck said single-disease approvals could take “as many as 10“ years. No standalone measles, mumps or rubella shot has been sold in the US since Merck stopped making them in 2008.
Goal to split MMR vaccine could take a decade, experts say · Reuters via KFGO
Sangamo selected PTC and Lilly as winning bankruptcy-auction bidders.
PTC bid $111m at closing plus up to $100m in approval milestones for the Fabry disease gene therapy isaralgagene civaparvovec. Lilly takes the capsid, zinc finger and MINT platforms and the prion disease programme for $50m. Winning bids total $163.6m in cash, subject to approval by the US Bankruptcy Court (Delaware) in Q3.
Sangamo selects successful bidders following asset auction · Sangamo Therapeutics
Thursday 13 August
The FDA proposed a 50% fee cut for US-based phase 1 trials.
The proposed PDUFA VIII commitment letter, covering fiscal years 2028 to 2032, would halve the application fee where a filing includes clinical data from at least one phase 1 trial run in the US and begun after 1 October 2027.
PDUFA VIII: Fiscal Years 2028-2032 · FDA
EMA says Tavneos approval relied on “incorrect and misleading” trial data.
The CHMP recommended revoking Tavneos (avacopan) in June, with the European Commission making that decision legally binding across the EU on 4 August. The EMA has now published the grounds for that decision, concluding that the ADVOCATE trial supporting approval breached good clinical practice and that its data could no longer be relied on to demonstrate effectiveness. CSL’s Vifor unit is managing the withdrawal.
Tavneos: Article 20 referral · European Medicines Agency
EC adopts decision to revoke marketing authorisation for TAVNEOS (avacopan) · CSL
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