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ALETH / LIFESCI-BRIEF / 2026-10-02 / ASTRAZENECA TO INVEST $2BN IN SUMMIT

AstraZeneca takes $2bn stake in Summit

Also this week: Lilly's EloraTZP cut more weight than Zepbound, Sanofi pays Regeneron $1bn upfront to extend alliance & Novo agrees to license Hengrui's weekly obesity pill.

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

The week in five lines:

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Weekend catch-up

Merck and Daiichi Sankyo withdrew their FDA application for a B7-H3 antibody-drug conjugate (ADC) in lung cancer.

The partners pulled the accelerated approval filing after the FDA said the data, including from the phase 2 IDeate-Lung01 trial, did not support it. Enrolment continues in the phase 3 IDeate-Lung02 trial.

The FDA approved Mirum’s Atebrioz for the ultra-rare bone disorder fibrodysplasia ossificans progressiva.

Atebrioz (zilurgisertib), an oral ALK2 inhibitor licensed from Incyte, is cleared for patients aged 12 and over. In the PROGRESS study, new heterotopic bone volume fell by 3.2 cm³ at week 24, against an increase of 24.6 cm³ on placebo. Mirum expects a US launch in October and puts annual revenue potential at >$200m.

The FDA approved Roche’s Gazyva for frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome.

The indication covers patients aged two and over who are in complete remission. In the phase 3 INShore study, 95% of patients on Gazyva (obinutuzumab) were relapse-free after week 8 and in complete remission at one year, against 73% on mycophenolate mofetil. Genentech calls it the first FDA-approved treatment for the disease in 70 years. It is Gazyva’s second immune-mediated approval, after lupus nephritis.

Ten of 20 myeloma patients given one Carvykti infusion after one to three prior lines remained alive and progression-free at five years.

At the International Myeloma Society meeting in Glasgow, 10 of 20 patients treated with Carvykti (ciltacabtagene autoleucel) in CARTITUDE-2 Cohort A remained progression-free without maintenance at a median 60.7 months of follow-up, and 69.2% were alive at five years.

BioWorld counted a record $199.2bn of biopharma deal value in the first eight months of 2026.

The January-August total was $186.5bn in 2025 and $111.9bn in 2019. May ($41.9bn) and June ($34.6bn) were among this year’s strongest months. BioWorld published figures on the med-tech sector, seeing $81.0bn of med-tech M&A value through August 2026, more than double a year earlier. The January-August total was $32.8bn in 2025. BioWorld puts the rebound down to fewer, bigger deals.

Scrip found that AI-led companies took five of the ten largest biopharma venture rounds of 2026.

Recent financings included Isomorphic Labs’ $2.1bn Series B, Earendil Labs’ $787m raise, Chai Discovery’s $400m Series C and Enveda’s $311m Series E. The concentration points to investors backing AI-led companies at biotech scale, particularly those combining computational platforms with their own drug-development pipelines.

The FDA approved AbbVie’s Juvmo for Parkinson’s disease.

Juvmo (tavapadon) is the first selective D1/D5 receptor agonist approved for the disease, taken once daily with or without levodopa. In the phase 3 TEMPO-3 trial it increased daily on-time without troublesome dyskinesia by 1.7 hours, against 0.6 hours on placebo.

Monday 28 September

Merck licensed a KRAS G12D inhibitor for $400m upfront.

SciBrunch Therapeutics granted worldwide rights to SPR2015, a preclinical oral molecular-glue inhibitor, in a deal worth up to $2.13bn with milestones. The transaction has closed.

Kodiak Sciences’ tarcocimab matched Eylea in a phase 3 trial in wet age-related macular degeneration.

In DAYBREAK, tarcocimab tedromer was non-inferior to Eylea (aflibercept) on vision gains at one year, and 54% of patients reached a six-month dosing interval under strict treat-to-dryness retreatment rules. Kodiak’s second candidate, tabirafusp alfa tedromer, also met its vision endpoint. Kodiak plans a three-indication filing for tarcocimab in Q4 2026.

Roche is returning antibody emugrobart to Chugai after an interim obesity analysis.

An interim analysis of the phase 2 GYMINDA study, which paired the anti-myostatin antibody with GLP-1/GIP drugs, found clinically meaningful weight loss unlikely. Chugai is preparing to restart development in spinal muscular atrophy, which Roche dropped in March, and is weighing an out-licence.

Mirum’s brelovitug met the primary endpoint of a phase 3 trial in chronic hepatitis delta.

At week 24 of AZURE-1, 56% of patients on 300 mg weekly and 45% on 900 mg every four weeks reached combined viral response and ALT normalisation, against none on delayed treatment (p<0.0001). Mirum plans to file a Biologics License Application (BLA) in H1 2027 and puts annual revenue potential at >$1bn.

AstraZeneca agreed to invest $2bn in Summit for about 12% of the company.

AstraZeneca is buying newly issued convertible preferred stock that gives it rights equivalent to about 12.0% of Summit’s common stock. The two will test Summit’s PD-1/VEGF bispecific ivonescimab with AstraZeneca’s Claudin 18.2 ADC sonesitatug vedotin in gastrointestinal cancers, each keeping the rights to its own drug. A memorandum of understanding points to a wider programme pairing ivonescimab with more AstraZeneca cancer drugs. Akeso, which engineered ivonescimab, keeps the rights in China and other regions.

The FDA approved Egetis Therapeutics’ Emcitate, the first US treatment for MCT8 deficiency.

Emcitate (tiratricol), a thyroid hormone receptor agonist, treats peripheral thyrotoxicosis in the X-linked disorder, in which median life expectancy is about 35 years. The Swedish company also received a rare paediatric disease priority review voucher, which it may sell in Q4 2026.

Tuesday 29 September

Novo Nordisk agreed to license Hengrui’s weekly obesity pill for up to $2.6bn.

Novo will pay $300m upfront for rights to HRS-1596 outside mainland China, Hong Kong, Macao and Taiwan. The phase 1-ready GLP-1/GIP dual agonist is designed for once-weekly oral dosing, and Hengrui has Chinese approval to start phase 1 trials in weight management and type 2 diabetes. The deal is expected to close in Q4 2026.

uniQure’s Huntington’s disease gene therapy missed significance on its primary measure at four years.

In 12 high-dose patients at 48 months, AMT-130 slowed progression on the composite cUHDRS score by 44% against an external control (p=0.144), and on Total Functional Capacity by 61% (nominal p=0.008). uniQure says missing data in the updated control understate the effect. Its BLA is anchored on previously reported 36-month data. An updated analysis of 15 high-dose patients at that timepoint showed 80% slowing on cUHDRS.

PhRMA named former House Majority Leader Eric Cantor as its next president and chief executive.

Cantor, latterly vice chairman of Moelis & Company, starts on 9 November. He succeeds Stephen Ubl, who has led the US drug industry’s lobby since 2015.

Oura postponed its IPO of up to $2.2bn, citing uncertainty in the market.

The smart ring maker had planned to sell 50 million shares at $40 to $44. It has 5.7 million paying members and expects revenue to rise 90% in its 2026 financial year.

Lilly’s retatrutide cut weight by 20.8% over 80 weeks in obesity and type 2 diabetes.

At the European Association for the Study of Diabetes (EASD) meeting in Milan (published in The Lancet), 59.5% of patients on the 12 mg dose in the phase 3 TRIUMPH-2 trial no longer met the BMI criteria for obesity, and HbA1c fell by up to 1.6%. Lilly plans to file in Q1 2027.

Bristol Myers Squibb tightened liver monitoring in the long-term extension of its phase 3 admilparant trial after liver injuries and a trial participant’s death.

BMS submitted the amendment for European trial sites in May, classifying liver injury as a newly important potential risk. A spokesperson confirmed a “limited number” of liver events, including a death involving liver injury, but said it was unclear whether the patient received admilparant. Shares in BMS and Contineum, which has a similar drug, fell late on Tuesday. BMS expects results by the end of the year.

Wednesday 30 September

Merck detailed phase 2b tulisokibart results in hidradenitis suppurativa.

At week 16, 72% of patients on the top dose of the anti-TL1A antibody reached HiSCR50, and 41% reached HiSCR75 against 15% on placebo. Merck, which gained tulisokibart in its $10.8bn Prometheus acquisition, will take it into phase 3 in the skin disease. Merck first said the study had met its endpoints in its Q2 results on 4 August.

Lilly’s EloraTZP cut more weight than Zepbound in type 2 diabetes.

In a 48-week phase 2b trial in 367 adults with obesity or overweight and type 2 diabetes, presented at EASD, the eloralintide and tirzepatide combination cut weight by up to 23.3% against 14.8% on Zepbound 15 mg. HbA1c fell by up to 2.9%, against 2.4%. Adverse events led 10.8% to 27.0% of patients on EloraTZP to stop treatment, against 2.9% on Zepbound, with gastrointestinal events most common. Lilly attributed the higher discontinuation rate partly to escalating doses of both drugs simultaneously and plans an optimised escalation schedule in phase 3.

The Centers for Medicare and Medicaid Services (CMS) finalised its GLOBE drug-pricing demonstration for Medicare Part B.

GLOBE will test a new rebate formula for certain Part B drugs against prices in economically comparable countries. The model starts on 1 January 2027, with a five-year performance period from 1 April 2027. CMS now projects $440m of Medicare Part B savings over the seven-year payment period, down from $11.9bn in the proposed rule.

Thursday 1 October

Sanofi to pay Regeneron $1bn upfront to widen their antibody alliance.

The Dupixent (dupilumab) partners will co-develop four long-acting Regeneron antibodies, against IL-13, IL-4 and IL-4Rα plus an IL-4xIL-13 bispecific, with up to $7bn more in milestones. The two will share development and commercialisation costs and split future profits 50:50, and the Dupixent profit share is unchanged. Only the IL-13 antibody REGN20423 is in the clinic, in phase 1 for atopic dermatitis. Regeneron leads research and development; Sanofi leads global commercialisation.

Boehringer Ingelheim’s survodutide cut weight by up to 13.1% in a phase 3 trial in obesity and type 2 diabetes.

In SYNCHRONIZE-2, 752 treated adults lost up to 13.1% at 76 weeks against 3.1% on placebo, on the efficacy estimand. HbA1c fell by up to 1.21%. Gastrointestinal side effects led 18% of patients on survodutide to stop treatment, against 1.2% on placebo. Boehringer said discontinuations usually occurred during dose escalation and later trials allow more flexible titration.

Regeneron’s trevogrumab halved lean-mass loss as an add-on to Wegovy in a phase 2 trial.

In COURAGE, adding 75 mg of trevogrumab to Wegovy (semaglutide) 2.4 mg reduced lean-mass loss by 50.7% relative to Wegovy alone at 26 weeks, without meaningfully adding to weight loss. In an MRI substudy it prevented about 70% of thigh-muscle loss. Regeneron plans a phase 2 in adults with obesity and low muscle mass.

Friday 2 October

AstraZeneca and Daiichi Sankyo agreed a clinical collaboration with Summit to test Datroway with ivonescimab.

The companies will evaluate the combination across multiple tumour types, including lung and breast cancers, beginning with a phase 3 trial in first-line triple-negative breast cancer. Each will retain development and commercial rights to its own drug and share trial costs.

Novartis agreed to pay Abogen $575m upfront for an mRNA-encoded T-cell engager.

China’s Abogen Biosciences has agreed to grant worldwide rights to ABO2203, a CD19xCD3 T-cell engager for autoimmune disease that is encoded in mRNA so the body makes the engager itself. Novartis also gets options on other programmes from Abogen’s RNA platform. If all options are exercised, milestones could reach $7.2bn.

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