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ALETH / LIFESCI-BRIEF / 2026-02-13 / FDA REFUSES TO REVIEW MODERNA’S FLU SHOT

FDA refuses to review Moderna's flu shot

Also this week: Isomorphic Labs “well beyond AlphaFold 3”, ICON accounting probe, Lilly in vivo CAR-T bet & BridgeBio's height-improvement pill meets phase 3 goal.

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines:

Browse by day:

Weekend catch-up

Roche’s oral BTK inhibitor fenebrutinib matched Ocrevus in primary progressive multiple sclerosis (PPMS).

In the 985-patient phase 3 FENtrepid trial, fenebrutinib met its primary endpoint of non-inferiority to Ocrevus (ocrelizumab) and cut risk of disability progression by 12% at 24 weeks. Fatal events ran at 1.4% against 0.2% on Ocrevus. Roche will submit its full phase 3 package once the relapsing-MS study FENhance 1 reads out in H1 2026.

Eli Lilly and Innovent Biologics signed their seventh collaboration, an oncology and immunology alliance worth up to $8.9bn.

Innovent will be paid $350m upfront and is eligible for up to $8.5bn in milestones plus royalties, and will run development to phase 2 proof-of-concept in China while Lilly gets rights everywhere outside Greater China.

Monday 9 February

Eli Lilly agreed to buy Orna Therapeutics for up to $2.4bn.

The deal takes Lilly into in vivo CAR-T, where a patient’s own cells are reprogrammed into cell therapies without being removed from the body. Orna’s lead candidate is a CD19-directed in vivo CAR-T for B-cell-driven autoimmune diseases, built on circular RNA. It is one of the largest acquisitions of an in vivo cell-therapy company to date.

Novo sued Hims & Hers for patent infringement over compounded semaglutide.

Novo’s complaint accuses Hims of infringing its US patent covering semaglutide, and seeks a permanent injunction and damages. Hims had said over the weekend it would stop offering the compounded pill after the FDA signalled enforcement.

The FDA issued a complete response letter for REGENXBIO’s RGX-121, its gene therapy for Hunter syndrome.

REGENXBIO disclosed that the agency had turned down its accelerated-approval filing for the ultra-rare paediatric disease, questioning the trial’s eligibility criteria, its natural-history control and the surrogate endpoint used. The FDA set out requirements, including a new controlled study, that are hard to run in such a small population.

DSM-Firmenich agreed to sell its Animal Nutrition & Health business to CVC at an enterprise value of about €2.2bn including an earn-out of up to €0.5bn.

The Swiss group expects to receive €1.2bn in value after closing, of which roughly €0.6bn is net cash, with it retaining a 20% stake in the unit, which had about €3.5bn of net sales in 2025. The sale, due to close by the end of 2026, largely completes its exit from animal nutrition to concentrate on fragrance, taste and health.

Takeda struck a multi-year AI drug discovery deal with Iambic Therapeutics worth >$1.7bn.

Takeda gains access to Iambic’s platform, including its generative model NeuralPLexer, to advance small-molecule programmes in oncology, gastrointestinal disease and inflammation. Iambic takes upfront and technology-access payments and is eligible for milestones that could exceed $1.7bn plus royalties.

Tuesday 10 February

The FDA refused to review Moderna’s next-generation flu vaccine.

Moderna said the Center for Biologics Evaluation and Research (CBER) had issued a refusal-to-file letter for mRNA-1010, objecting solely to the trial’s comparator arm, a licensed standard-dose flu vaccine, which it said did not reflect the best-available standard of care. Moderna said the letter raised no safety or efficacy concern.

Moderna rejected the reasoning, noting the FDA had reviewed both phase 3 designs before the trials began and that the filing rested on two positive studies in 43,808 participants that met all primary endpoints. It has requested a Type A meeting.

AstraZeneca reported 8% sales growth for 2025 and held its $80bn 2030 target.

Revenues rose 8% at CER (9% AER) to $58.7bn and core earnings per share 11% at CER to $9.16, and chief executive Pascal Soriot reaffirmed the 2030 goal, underpinned by more than 25 planned blockbusters and expansion in the US and China.

CSL said CEO Paul McKenzie would retire and, a day later, issued a profit warning.

Company veteran Gordon Naylor, a former Seqirus president, steps in as interim with the plasma and vaccines group under investor pressure. First-half net profit came in at US$401m, down 81% at constant currency, after about US$1.1bn of impairments against CSL Seqirus and CSL Vifor assets tied to falling US vaccine demand.

Isomorphic Labs unveiled a drug design engine it says goes well beyond AlphaFold 3.

The London-based Alphabet company said its proprietary engine roughly doubles AlphaFold 3’s accuracy on the hardest ligand-binding cases, reaching about 50% on cases with little similarity to training data, against about 23% for AlphaFold 3.

Wednesday 11 February

Madrigal paid $60m upfront for six preclinical siRNA programmes from China’s Ribo, worth up to $4.4bn.

The licence gives Madrigal exclusive global rights to the MASH candidates, built on Ribo’s GalSTAR liver-targeting platform, to combine with its approved MASH drug Rezdiffra (resmetirom). Another deal to build its combination options around Rezdiffra.

The FDA approved Keytruda in platinum-resistant ovarian cancer, a tumour type the drug had never cracked.

Merck said the agency cleared Keytruda plus paclitaxel with or without Avastin for adults with PD-L1-positive platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer in the second or third line. The FDA cleared Agilent’s PD-L1 IHC 22C3 pharmDx as the companion diagnostic alongside it.

Thursday 12 February

Sanofi named a new chief executive to succeed Paul Hudson.

Sanofi has appointed Belén Garijo, chief executive of Merck KGaA since 2021 and the first woman to lead a DAX40 company, to the top job. Sanofi said Garijo would bring increased rigour to its strategy and R&D, with the growth of Dupixent under scrutiny.

BridgeBio’s infigratinib met its phase 3 goal in achondroplasia.

The oral FGFR1-3 selective tyrosine kinase inhibitor improved annualised height velocity by a mean 2.10 cm/year over placebo at week 52 in the PROPEL 3 trial in children (p<0.0001), and met its key secondary on height Z-score. BridgeBio plans US and European filings in H2 2026, setting up a challenge to BioMarin’s Voxzogo.

European life sciences investors managing >€24bn launched a coalition.

Novo Holdings, Sofinnova, Forbion, Omega Funds and HealthCap were among the members founding the European Life Sciences Coalition in Brussels, alongside Invest Europe, to press for more capital to scale the region’s biotech companies.

The coalition put Europe at 7% of global life sciences venture capital against 63% for the United States and 14% for China, and noted that 66 of 67 EU biotech companies to list in the past six years chose to do so outside the EU.

ICON disclosed an accounting investigation and pulled 2025 guidance.

The CRO said a probe into revenue recognition had preliminarily found revenue in 2023 and 2024 may each have been overstated by less than 2%. It delayed its full-year results to 30 April and said it expects to report one or more material weaknesses.

The FDA removed three risk statements from boxed warnings on six menopausal hormone therapy products.

The agency approved labelling changes stripping the warnings on cardiovascular disease, breast cancer and probable dementia from Prometrium, Divigel, Cenestin, Enjuvia, Estring and Bijuva, after a scientific-literature review begun in November 2025.

PTC Therapeutics withdrew its US filing for the Duchenne drug Translarna.

PTC pulled its NDA resubmission for Translarna in nonsense-mutation DMD after the FDA indicated the data were unlikely to meet its threshold of substantial evidence of effectiveness, This was its third failed attempt to secure US approval for the drug.

Friday 13 February

Novartis said Vanrafia slowed kidney-function decline in IgA nephropathy, though its key secondary endpoint missed significance.

In the phase 3 ALIGN study, Vanrafia showed an eGFR difference over placebo of 2.39 mL/min/1.73 m² at week 136, the final analysis’s key secondary endpoint, that fell short of statistical significance (p=0.057). Vanrafia already holds accelerated US and China approval and Novartis plans to file for approval in 2026 regardless of the miss.

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