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ALETH / LIFESCI-BRIEF / 2026-10-23 / MODERNA PULLS BACK ON DETAILED CANCER DATA

Moderna pulls back on detailed cancer data

Also this week: EQT’s €10.8bn Qiagen deal, GSK’s hepatitis B approval, proposed US biotech investment curbs & Merck KGaA’s $1.3bn Silence deal.

The Aleth Briefs link to the sources behind the stories and show how the week unfolded.

The week in five lines:

Browse by day:

Monday 19 October

Merck KGaA agreed to buy London’s Silence Therapeutics for $1.3bn.

The German group will pay $20 in cash per ADS, a 130% premium to Friday’s close, valuing the equity at $1.3bn and the enterprise at $1.1bn. It gains divesiran, an siRNA drug for the blood disorder polycythaemia vera that is heading into phase 3. The UK scheme of arrangement is expected to close in Q1 2027.

Roche licensed ADCs from China’s Hansoh for $400m upfront and >$15bn in contingent milestones.

Hansoh also receives $110m on the deal’s first anniversary, plus tiered royalties. The collaboration covers two preclinical ADCs and additional programmes against Roche-proposed targets. Hansoh will take them through phase 1a before handing development outside mainland China, Hong Kong, Macau and Taiwan to Roche. Hansoh retains rights in those territories. The deal is the partners’ second in ADCs.

Disc Medicine’s bitopertin met every primary and secondary endpoint in a phase 3 trial in erythropoietic protoporphyria.

In the 183-patient APOLLO trial, Disc reported a 41.4% placebo-adjusted reduction in blood protoporphyrin IX. Patients gained 12.2 additional pain-free hours in light during month six vs placebo. Disc plans to resubmit its FDA application by end 2026.

The FDA granted accelerated approval to GSK’s Jemperli (dostarlimab) for MSI-high or mismatch repair-deficient locally advanced rectal cancer.

It is the first immunotherapy approved for these stage II and III patients and could spare some of them chemotherapy, radiation and surgery. In the phase 2 AZUR-1 trial, 68% of evaluable patients (98/144) achieved a sustained clinical complete response at 12 months without surgery. No disease recurrences were reported among responders after a median follow-up of >2 years.

EyePoint’s vorolanib eye insert missed the primary endpoint in its second phase 3 trial in wet age-related macular degeneration.

Preliminary topline results from LUCIA failed to establish that the six-monthly insert was non-inferior to Eylea (aflibercept) given every eight weeks. Patients gained 2.5 letters of vision against 6.1 with Eylea, while receiving 38% fewer injections after loading doses. EyePoint is now focused on its diabetic macular oedema trials, which are expected to read out in Q4 2027.

City Therapeutics closed its Nasdaq IPO, raising $230m.

The RNAi developer sold 12.78m shares at $18, including the full exercise of the underwriters’ option. Trading began on 16 October under the symbol CTY.

Tuesday 20 October

The FDA approved GSK’s Hibsago, a six-month hepatitis B treatment aimed at functional cure.

Hibsago (bepirovirsen) is a first-in-class antisense drug. In the B-WELL phase 3 trials, 19% of patients in the approved population reached functional cure: HBV DNA and HBsAg remained undetectable for at least 24 weeks after stopping all treatment. Standard antivirals alone typically achieve <1% functional cure after a year. The drug received priority review and Breakthrough Therapy designation. Patients can inject themselves after the first dose.

Myriad Genetics agreed to sell its prenatal testing business to Labcorp for $210m in cash.

Labcorp expects the business to add about $160m of revenue in year one. The deal should close by early 2027. The proceeds exceed half Myriad’s pre-announcement market value, and it expects the disposal to improve its growth and profitability.

The median net launch price of new US drugs rose 35% in real terms from 2022 to 2025, to $257,000 a year, ICER and West Health found.

About one in four drugs launched in 2025 cost >$500,000 a year net. Only about one in three newly approved drugs previously reviewed by the Institute for Clinical and Economic Review were priced at or below its value benchmark. During the first year after approval, only a third of outpatient prescriptions were filled within 30 days of an attempt to fill them.

Sanofi partnered with Cambridge, UK, start-up ScionxBio to make longer-lasting versions of some of its mRNA candidates.

ScionxBio, formed through a split of Eleven Therapeutics, will optimise the molecules with its TERA platform through in vivo validation. Sanofi will then take over development and commercialisation. The disease areas are undisclosed.

Wednesday 21 October

EQT agreed to take Qiagen private at a €10.8bn enterprise value.

The Swedish buyout firm’s EQT XI fund offers €46.50 a share in cash, a 40.3% premium to Qiagen’s price before takeover reports surfaced in July. The enterprise value is equivalent to about $12.1bn, including net debt. ADIA and CPP Investments are co-investing. Qiagen’s boards recommend the offer. It needs acceptances from >50% of shares and should close in mid-2027, subject to regulatory and other conditions.

Cencora agreed to buy American Oncology Network, a physician-led group of >350 cancer care providers, at an enterprise value of up to $2.4bn.

Cencora already owns about 4%. If existing stockholders retain a quarter of the equity, it expects to pay about $1.7bn to increase its ownership to 75%. The enterprise value includes up to $100m in contingent value rights.

Abbott plans to spin off its nutrition business, which has $8.5bn in annual sales and brands including Ensure and Similac.

The planned tax-free distribution to Abbott shareholders should complete by the end of 2027. Daniel Salvadori, who runs established pharmaceuticals and nutrition, will lead the new company.

Thermo Fisher Scientific’s Q3 revenue rose 9% to $12.1bn (+6% organic).

Adjusted EPS rose 15% to $6.68.

Roivant’s Lisraya (brepocitinib) met its primary and all key secondary endpoints in two phase 3 trials in non-infectious uveitis.

Across the 371 patients in CLARITY-1 and CLARITY-2, median time to treatment failure exceeded 48 weeks on the drug, against about 12 weeks on placebo in each trial. In the pooled analysis, 62% had inactive disease without steroids at week 48, against 20%. Priovant plans a US filing in H1 2027.

The FDA granted accelerated approval to AstraZeneca’s Ultomiris to reduce proteinuria in adults with primary IgA nephropathy at risk of progression.

Approval rests on a 43.4% placebo-adjusted reduction in urine protein at 34 weeks, from an interim analysis of the phase 3 I CAN trial. Whether the drug slows kidney function decline is not yet established.

The UK government confirmed it will keep accepting CE marked medical devices in Great Britain indefinitely.

CE marked (EU approved) devices make up >90% of those registered for use in Great Britain and will not require a separate UKCA approval. The UKCA mark remains available as the domestic route. The consultation drew >1,000 responses.

Astellas signed a miniprotein drug discovery deal with AI Proteins, which is eligible for >$400m in upfront and milestone payments.

Astellas holds an exclusive worldwide licence to resulting candidates and will handle development and commercialisation. AI Proteins would earn royalties on any sales.

Eli Lilly’s triple agonist retatrutide reduced obstructive sleep apnoea severity in two phase 3 trials published in NEJM.

In adults with overweight or obesity but without diabetes, the weekly 9mg dose reduced the apnoea-hypopnoea index by a mean 34.3 events an hour at 80 weeks, against 9.9 on placebo, from a baseline of 58.6. In patients with type 2 diabetes, the corresponding reductions were 24.7 and 10.3 events an hour.

Thursday 22 October

Moderna and Merck’s personalised cancer vaccine cut melanoma recurrence or death risk by 42% in phase 3.

In INTerpath-001, intismeran autogene, an mRNA therapy tailored to each patient’s tumour, was added to Keytruda after surgery for stage IIB–IV melanoma. At a median 24.6 months’ follow-up, estimated two-year recurrence-free survival was 82.2%, versus 70.0% with Keytruda alone (hazard ratio 0.58). The risk of distant metastasis or death fell 38%. Overall survival data are not yet mature. The results have been accepted for publication in NEJM. The companies are discussing the data with regulators.

The data leaked online on Thursday, prompting the release two days before the scheduled ESMO presentation. Moderna’s shares fell about 25% intraday. Moderna had risen over fourfold following August’s initial data. Analysts at UBS and William Blair characterised the pullback as a sell-the-news reaction following that rally.

The US Treasury proposed adding biotechnology to its curbs on outbound investment.

The draft rules implement the Comprehensive Outbound Investment Security (COINS) Act, passed in the 2026 National Defense Authorization Act. US investors would have to notify Treasury of certain transactions involving companies linked to countries of concern and would be barred from others. The Act names five technology sectors. The Treasury Secretary added biotechnology to the proposed regulations. Treasury is seeking feedback on the draft.

Roche’s sales rose 7% CER in Q3, and it confirmed its 2026 outlook.

Nine-month group sales grew 6% CER. Diagnostics sales rose 4% to CHF10.3bn, as core lab and pathology demand outweighed China’s healthcare pricing reforms. Roche now aims to bring up to 20 new medicines to patients by 2030. The day before, Roche announced pooled phase 3 data showing its oral MS drug fenebrutinib reduced annual relapse by 55% against teriflunomide in relapsing MS.

Gilead agreed to pay $1.275bn upfront for PepStar Therapeutics’ oral IL-23 receptor inhibitor programme.

Lead drug HCXT-2001 is a clinical-stage oral macrocyclic peptide. Gilead sees potential as a daily treatment for IBD, alone or with emvistegrast.

AbbVie’s lutikizumab met its phase 3 endpoint in hidradenitis suppurativa.

At week 16, 31.4% of patients reached HiSCR75, against 23.4% on placebo. This requires at least a 75% reduction in the combined abscess and inflammatory nodule count, with no increase in abscesses or draining fistulae. The 1,400-patient INTREPID trial also met eight ranked secondary endpoints.

Friday 23 October

Lycia Therapeutics priced its enlarged Nasdaq IPO to raise $318m.

The company priced 17.64m shares at $18, with trading expected to begin on Friday under the symbol LYCA. The offering is expected to close on 26 October. Lycia develops drugs that degrade disease-causing proteins outside cells. Its lead IgE degrader is in phase 1 for allergic disease.

Talks to merge Johnson & Johnson’s orthopaedics business with Smith & Nephew collapsed over who would run the combined company, the FT reported.

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