Grail files Galleri for FDA approval
Also this week: AZ commits $15bn to China, Roche’s obesity shot hits 22.5% weight loss & Medicare picks 15 more drugs for price talks.
ALETH / LIFESCI-BRIEF / 2026-01-30 / GRAIL FILES GALLERI FOR FDA APPROVALThe Aleth Briefs trace each story to its original source and show how the week unfolded.
The week in five lines
GRAIL filed Galleri for FDA approval
AstraZeneca committed $15bn to China.
Roche reported 22.5% placebo-adjusted weight loss for CT-388.
Medicare picked 15 more drugs for price talks.
FDA lifted Intellia’s phase 3 CRISPR trial hold.
In this edition
Weekend catch-up: NHS cancer register; Guardant injunction; Merck-Revolution talks end
Monday: UK biotech IPOs; AZ Cambridge; Genmab halt; Elevidys follow-up
Weekend catch-up
NHS England launched a national register for people carrying inherited variants that increase cancer risk.
The register covers >100 genes and gives the NHS a route to monitor and recall people for tests.
Thousands at risk of inherited cancers to receive regular NHS checks through world-first genetics programme - NHS England
Patent Court rejects Guardant’s injunction request against Sophia Genetics.
The Paris Local Division refused provisional measures over Sophia’s liquid-biopsy test. It found two patents more likely than not invalid for added matter and said infringement of the third had not been shown with sufficient certainty.
Final Order, Guardant Health v. Sophia Genetics, UPC_CFI_808/2025 - Unified Patent Court
Merck was no longer in talks to buy Revolution Medicines, The Wall Street Journal reported.
Merck No Longer in Talks to Buy Revolution Medicines - The Wall Street Journal
Monday 26 January
UK drug developers considering IPOs after a four-year domestic biotech drought.
The BioIndustry Association (BIA) told Fierce Biotech that companies were looking at Nasdaq. Baker McKenzie lawyers expected at least two possible London biotech listings in 2026.
‘Things are looking up’: British biotechs consider going public after years long IPO drought - Fierce Biotech
AstraZeneca kept its planned £200m Cambridge expansion on hold.
The company said its planning application preserved the option to build rather than restarting the project. The proposed site would employ about 1,000 people.
AstraZeneca keeps UK research site on pause, but options open - Fierce Biotech
Genmab stopped trial enrolment of cancer candidate acquired in $1.8bn ProfoundBio acquisition.
Endpoints reported that the halt affected an early-stage programme. Genmab bought ProfoundBio in 2024 to acquire its antibody-drug conjugate pipeline.
Sarepta said three-year data showed Elevidys slowed the loss of motor function in ambulatory Duchenne patients.
Elevidys (delandistrogene moxeparvovec) produced at least 70% less decline than a propensity-weighted external control on time to rise and the 10-metre walk or run. The follow-up covered 52 patients from EMBARK.
Tuesday 27 January
Roche’s CT-388 produced 22.5% placebo-adjusted weight loss
The highest once-weekly dose had not reached a weight-loss plateau at 48 weeks. Some 54% of recipients ended below the obesity threshold, against 13% on placebo, and Roche said phase 3 was expected to begin in Q1.
Waters shareholders approved the combination with BD’s Biosciences.
99% of shares represented at the meeting voted in favour. Waters said regulatory approvals were in place and expected the transaction to close on 9 February.
The FDA lifted the hold on Intellia’s phase 3 MAGNITUDE-2 CRISPR trial.
The decision restarts enrolment of patients with hereditary transthyretin amyloidosis with polyneuropathy. The MAGNITUDE cardiomyopathy trial remained paused.
The EU and India concluded negotiations on a free-trade agreement.
Once signed, ratified and in force, the agreement would eliminate or reduce tariffs on >96% of EU goods exports into India, including 11% tariffs on pharmaceuticals.
EU and India conclude landmark Free Trade Agreement - European Commission
CMS selected 15 medicines for the third Medicare price-negotiation cycle.
The round includes Part B medicines for the first time. Negotiations run through 2026 and the resulting prices take effect on 1 January 2028.
The FDA approved J&J’s Darzalex Faspro quadruplet for multiple myeloma.
Darzalex Faspro (daratumumab and hyaluronidase) can now be combined with bortezomib, lenalidomide and dexamethasone in adults ineligible for an autologous stem-cell transplant.
Wednesday 28 January
Eli Lilly signed a hearing-loss gene-editing deal with Seamless Therapeutics.
Seamless will design programmable recombinases that can make large, precise DNA changes without relying on the cell’s repair machinery. Lilly receives rights to develop the resulting therapies. Potential payments exceed $1.1bn.
The FDA placed two REGENXBIO gene therapies on clinical hold after a brain tumour was found in a treated child.
The five-year-old had received RGX-111 four years earlier. Preliminary analysis found AAV integration associated with PLAG1 overexpression. RGX-121 was also held because the programmes share relevant risks.
Cellares raised $257m to expand automated cell-therapy manufacturing.
BlackRock and Eclipse co-led the Series D, taking total capital raised to $612m. Cellares expects clinical manufacturing in H1 2026 and commercial-scale in 2027.
Danaher’s Q4 revenue rose 4.5% to $6.8bn.
Full-year revenue increased 3% to $24.6bn. The life-science tools group guided to 3% to 6% core revenue growth for 2026.
An NIH-funded study selected seven public programmes to assess feasibility of integrating whole genome sequencing into public health newborn screening.
BEACONS chose Iowa, Minnesota, New York, Oregon, Puerto Rico, South Carolina and Texas. Its gene list targets conditions that can be acted on during a child’s first year.
BEACONS Selects Seven Sites, Finalizes Gene List for Genomic Newborn Screening Study - Ariadne Labs
The FDA approved Tenpoint’s combination eye drop Yuvezzi for presbyopia.
Yuvezzi (carbachol and brimonidine) combines two established agents in a formul-ation for adults with blurry close-up vision due to age. Tenpoint plans a Q2 US launch.
Thursday 29 January
AstraZeneca committed $15bn to China through 2030.
The investment covers research and manufacturing, including cell therapy and radioconjugates. AstraZeneca said it would expand its existing R&D centres in Beijing and Shanghai and increase its Chinese workforce beyond 20,000.
Roche reported 2025 sales growth of 7%
Sales reached CHF 61.5bn +7% CER, or 2% in CHF. Roche forecast mid-single-digit sales growth at constant currencies for 2026.
Thermo Fisher Scientific’s 2025 revenue rose 4% to $44.6bn.
Q4 revenue increased 7% to $12.2bn. Adjusted earnings per share rose 5% for the year. Thermo guided to 2026 revenue of $46.-$47.2bn, representing growth of 4%-6%.
Sanofi deprioritised its next-generation mRNA seasonal flu vaccine programme, Fierce Biotech reported.
Sanofi said it did not anticipate a near-term launch. Its existing protein-based influenza portfolio remains in development and on the market.
Sanofi scraps attempt to develop mRNA seasonal flu vaccine - Fierce Biotech
GRAIL submitted Galleri for FDA premarket approval.
The final module completes the application for its multi-cancer early-detection (MCED) blood test. The filing draws on PATHFINDER 2 and the NHS-Galleri trial.
GRAIL Submits FDA PMA Application for the Galleri® Multi-Cancer Early Detection Test
Repertoire and Eli Lilly signed an autoimmune collaboration worth up to $1.9bn plusroyalties.
Repertoire receives $85m upfront and up to $1.84bn in milestones. It will use its DECODE platform to nominate tolerising therapies before Lilly takes over clinical development and commercialisation.
Friday 30 January
AstraZeneca agreed to pay CSPC $1.2bn upfront for eight long-acting obesity and diabetes programmes.
AstraZeneca would receive ex-China rights to the portfolio, led by once-monthly GLP-1/GIP candidate SYH2082. Closing was expected in Q2. CSPC can receive up to $3.5bn in development and regulatory milestones, plus sales payments and royalties.
ALETH · OPEN ACCESS RESEARCH