The Aleth Briefs trace each story to its original source and show how the week unfolded.
The week in five lines
Brussels unveiled its EU Biotech Act.
Sanofi struck two biotech deals in one day.
The US CDC ended universal newborn hepatitis B dosing.
Medline raised $6.3bn in the year’s biggest IPO.
The US Biosecure Act was signed into law.
In this edition
Weekend catch-up: Arcus/Gilead TIGIT failure; Innoviva gonorrhoea pill; Sobi-Arthrosi gout
Monday: Sanofi MS miss; Sanofi’s $2.84bn deal day; Enhertu first-line; FDA on Covid vaccines
Tuesday: EU Biotech Act; Medline record IPO; GSK asthma approval; US hepatitis B; Pfizer 2026
Thursday: Takeda psoriasis pill; Novo CagriSema filing; Daiichi-Merck ADC hold
Weekend catch-up
Arcus Biosciences and Gilead abandon upper-GI domvanalimab studies on phase 3 futility.
On Friday the partners said the phase 3 STAR-221 study in first-line advanced gastric and oesophageal cancer had been stopped for futility on the recommendation of its monitoring committee. The anti-TIGIT antibody domvanalimab with zimberelimab and chemotherapy did not improve overall survival against Opdivo (nivolumab) and chemotherapy across 1,040 patients. STAR-221 is another heavy setback for a class that Roche, Merck and BMS have stepped back from.
Innoviva won FDA approval for Nuzolvence, the second first-in-class oral gonorrhoea antibiotic cleared in as many days.
On Friday, a day after GSK’s Blujepa, the FDA approved Innoviva’s Nuzolvence (zoliflodacin), a single-dose oral antibiotic for uncomplicated urogenital gonorrhoea in patients aged 12 and over weighing at least 35 kg. Approval rested on a phase 3 trial in 930 patients in which one dose was non-inferior to injectable ceftriaxone plus oral azithromycin. Developed with the non-profit Global Antibiotic Research and Development Partnership.
Sweden’s Sobi agreed to buy Arthrosi Therapeutics for up to $1.5bn.
Announced on Saturday, the deal pays $950m upfront in cash with up to $550m more in clinical, regulatory and sales milestones. It brings pozdeutinurad (AR882), a once-daily oral URAT1 inhibitor in two fully enrolled phase 3 trials in progressive and tophaceous gout, with data due in 2026. The sale came shortly after Arthrosi closed a $153m series E. The acquisition takes rare-disease specialist Sobi into a common disease area where there have been few late-stage deals of this scale.
Monday 15 December
Sanofi’s BTK inhibitor tolebrutinib failed a phase 3 in primary progressive MS.
The phase 3 PERSEUS study in primary progressive multiple sclerosis, which accounts for about a tenth of MS, missed its primary endpoint. with no significant delay to confirmed disability progression against placebo. Sanofi will not seek registration in that disease form but remains confident in the drug for non-relapsing secondary progressive MS, where a US decision is pending.
Sanofi announced two biotech deals in one day worth up to $2.8bn.
Sanofi expanded its collaboration with Dren Bio, paying $100m upfront and up to $1.7bn in milestones for a next-generation B-cell-depleting therapy for autoimmune disease, building on its acquisition of Dren’s DR-0201 earlier in the year. Hours later it licensed ADEL-Y01, a tau-targeting Alzheimer’s antibody from South Korea’s ADEL, for $80m upfront within a total potential value of up to $1.04bn, plus tiered royalties.
The FDA approved Enhertu with Perjeta for first-line HER2-positive metastatic breast cancer.
The clearance, announced by AstraZeneca and Daiichi Sankyo, moves the antibody-drug conjugate Enhertu (trastuzumab deruxtecan) into the front line alongside Roche’s Perjeta (pertuzumab), the first new first-line option in over a decade. In the phase 3 DESTINY-Breast09 trial the combination cut the risk of disease progression or death by 44% against the standard taxane, trastuzumab and pertuzumab regimen, with median progression-free survival of 40.7 months against 26.9 months.
The FDA said it has no plans to put a boxed warning on Covid-19 vaccines.
FDA commissioner Marty Makary said the agency had no plans to add a boxed warning, its strongest label, to Covid-19 vaccines, contradicting a report days earlier that it was preparing to. He said some officials had recommended the warning but that leadership, including CBER director Vinay Prasad, did not consider it necessary. The exchange is the latest turn in an internal fight over vaccine safety messaging under the current US health leadership.
Tuesday 16 December
The European Commission unveiled an EU Biotech Act to slow biotech’s drift to the US and China.
In an initiative meant to close Europe’s innovation gap: the commission proposed faster clinical trials, smoother rules for cell and gene therapies, more biomanufacturing capacity and easier access to capital for start-ups, alongside new biosecurity screening. The Commission notes that EU biotech has grown at roughly twice the rate of the wider economy over a decade, contributing about €40bn to GDP.
Q&A on the European Biotech Act - European Commission
Medline raised $6.27bn in the biggest IPO of 2025.
The medical-supplies group, taken private in 2021 by Blackstone, Carlyle and Hellman & Friedman, priced 216 million shares at $29, the largest private-equity-backed listing on record by money raised. Shares began trading on the Nasdaq and jumped about 41% to around $41. Medline had shelved an earlier 2025 listing attempt because its China-heavy supply chain left it exposed to tariffs.
The FDA approved GSK’s twice-yearly asthma biologic Exdensur.
Exdensur (depemokimab) is an ultra-long-acting anti-IL-5 antibody dosed every six months, cleared as add-on maintenance for severe asthma with an eosinophilic phenotype in patients age 12 and over. In the phase 3 SWIFT-1 and SWIFT-2 trials it cut annual exacerbations by 58% and 48% against placebo over 52 weeks. GSK has guided to around £3bn ($4bn) in peak-year sales for the drug.
Exdensur (depemokimab) approved by the US FDA for severe asthma - GSK
GSK closes on approval of asthma hope depemokimab - pharmaphorum
The US CDC ended recommendation newborns receive a hepatitis B vaccine.
The CDC adopted the change following an 8-3 vote by its reshaped advisory committee on 5 December to replace the universal birth-dose policy, in place since 1991, moving to shared decision-making for babies born to mothers testing negative for hepatitis B. Where a mother is positive or status unknown, the birth dose and immunoglobulin still stand. Paediatric groups have opposed the move, the latest change to the US childhood schedule under health secretary Robert F Kennedy Jr.
Pfizer guided to lower 2026 revenue and leaned on obesity to fill the gap.
Pfizer forecast 2026 revenue of $59.5bn to $62.5bn, a midpoint below this year, and its shares fell about 5%. Falling Covid sales and a multi-billion-dollar patent cliff sit behind the outlook. The company plans around 20 pivotal trials next year, ten of them on the ultra-long-acting obesity assets it gained in its $10bn Metsera acquisition, its bet to rebuild growth after dropping two earlier obesity candidates.
Pfizer 2026 financial guidance - SEC (Pfizer Form 8-K)
Wednesday 17 December
The US Senate cleared the Biosecure Act, sending it to become law.
The Senate passed the 2026 National Defense Authorization Act by 77 to 20, carrying with it a softened Biosecure Act as Section 851. The provisions restrict federal contracts with biotech companies that the Office of Management and Budget designates as “companies of concern”; the enacted text names no firms and takes effect only after later guidance. The House had passed the package on 10 December. It ends a two-year effort that had repeatedly failed as standalone legislation.
BIOSECURE Act included in the FY2026 National Defense Authorization Act - Sidley
SASC leaders commend final passage of the FY2026 National Defense Authorization Act - US Senate Committee on Armed Services
Statement by the President on S. 1071 - The White House
Thursday 18 December
Takeda’s zasocitinib cleared two phase 3 psoriasis trials.
Takeda said the once-daily oral TYK2 inhibitor met co-primary endpoints in two LATITUDE-PsO studies in moderate-to-severe plaque psoriasis: >50% patients reached PASI 90, near-clear skin, at 16 weeks. Takeda, which acquired the molecule from Nimbus in 2023, plans to file in the US in FY2026. An oral that matches the class on skin clearance would set it against BMS’s Sotyktu in a crowded market.
Takeda’s zasocitinib delivers positive phase 3 plaque psoriasis data
Takeda completes acquisition of Nimbus Therapeutics’ TYK2 programme subsidiary
Novo Nordisk filed its next big obesity bet CagriSema for US approval.
Novo submitted a marketing application to the FDA for CagriSema, a once-weekly injection combining amylin analogue cagrilintide with semaglutide. In the phase 3 REDEFINE 1 it produced weight loss of 20.4% against 3.0% on placebo, rising towards 23% in patients who stayed on treatment. The filing is Novo’s attempt to strengthen its semaglutide franchise and counter Eli Lilly at the top of the obesity market.
Novo Nordisk files for FDA approval of CagriSema - Novo Nordisk
An October FDA hold on Daiichi-Merck’s I-DXd lung-cancer trial comes to light.
Trade reporting disclosed the FDA had verbally placed the phase 3 IDeate-Lung02 trial in small-cell lung cancer on partial clinical hold in October, after a higher-than-expected number of fatal interstitial lung disease events. The trial is of ifinatamab deruxtecan (I-DXd), an ADC in Daiichi Sankyo and Merck’s oncology alliance.
Patient deaths prompt partial hold on Daiichi/Merck’s phase 3 ADC - Fierce Biotech
Merck/Daiichi ifinatamab deruxtecan hit with clinical hold - BioPharma Dive