Aleth LifeSci Brief: 10-14 Nov 2025
Big progress in cardiology at AHA
ALETH / LIFESCI-BRIEF / 2025-11-14 / BIG PROGRESS IN CARDIOLOGY AT AHAIn this edition
Wednesday: FDA drug chief; UK animal testing; UK-China science; Grail FDA filing
Friday: Merck buys Cidara; BMS-J&J blood thinner; Lundbeck-Avadel; Kura AML approval
Stories of the week: cardiology data at AHA
Amgen’s Repatha cut the risk of a first major cardiac event by a quarter in people who had never had one.
In the Phase 3 VESALIUS-CV trial presented at AHA (published in NEJM) >12,000 high-risk adults with atherosclerotic disease or high-risk diabetes but no prior heart attack or stroke were enrolled, a population far larger than that for existing PCSK9 drugs. Repatha (evolocumab) produced a 25% relative reduction in the three-point composite of coronary heart disease death, heart attack or ischaemic stroke, a 19% cut in the wider four-point measure, and a 36% reduction in heart attacks alone. The question the result opens is how far upstream cholesterol-lowering should now move.
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AstraZeneca’s baxdrostat cut blood pressure by 14 mmHg in patients whose hypertension resists the usual drugs.
The Phase III Bax24 trial measured a placebo-adjusted fall of 14.0 mmHg in 24-hour average systolic pressure at 12 weeks, on top of standard care, in people with resistant hypertension. Seven in ten patients on baxdrostat brought their average below 130 mmHg, against fewer than two in ten on placebo. Baxdrostat, an aldosterone synthase inhibitor that came to AstraZeneca through its $1.3bn purchase of CinCor, was presented at AHA and published in The Lancet.
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Baxdrostat Bax24 Phase III trial full results - AstraZeneca
Merck’s oral PCSK9 pill matched the LDL cuts of the injectables it hopes to displace.
In the Phase 3 CORALreef Lipids trial presented at AHA, enlicitide decanoate, a once-daily tablet, lowered LDL cholesterol by 55.8% against placebo at week 24; a companion trial in inherited high cholesterol showed a 59.4% cut. The existing PCSK9 drugs, from Amgen and from Sanofi and Regeneron, are antibodies given by injection, so a pill at similar potency widens the market to patients who will not or cannot inject.
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Merck’s enlicitide decanoate significantly reduced LDL-C in Phase 3 CORALreef Lipids trial - Merck & Co
Monday 10 November
Pfizer won the obesity biotech Metsera, and Novo Nordisk walked away.
Novo said it would not raise its Metsera offer again, ending a fortnight of open bidding. Its final proposal on 6 November, matched Pfizer on headline terms: $65.60 a share in cash plus contingent value rights of up to $20.65. What it could not match was certainty, with the US antitrust risk in Novo’s two-step structure hanging over the vote.
Pfizer completed the purchase on 13 November for $65.60 in cash, an enterprise value of about $7bn, plus a contingent right (CVR) of up to $20.65 tied to clinical and regulatory milestones. Metsera is now a wholly owned subsidiary of Pfizer, which has its way back into obesity. Novo kept its discipline and cash.
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Roche’s fenebrutinib met its goals in two phase 3 multiple sclerosis trials at once.
FENhance 2, in relapsing MS, significantly cut the annual relapse rate against teriflunomide over at least 96 weeks. FENtrepid, in primary progressive MS, was non-inferior to Roche’s own Ocrevus on delaying confirmed disability progression, with a numerical edge for fenebrutinib appearing by week 24. Fenebrutinib is a dual BTK inhibitor, a class in which Merck KGaA and Sanofi have struggled; the last relapsing-MS study, FENhance 1, reads out in H1 2026.
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Personalis won Medicare coverage for its ultrasensitive test to track breast cancer recurrence.
Coverage applies to Medicare patients with stage II and III disease across the main subtypes, for monitoring recurrence for up to six years after treatment. Reimbursement is the gate that decides whether a MRD test reaches routine use, and Personalis cited data that its NeXT Personal assay flagged recurrence a median of 15 months before standard imaging. The decision extends the company into a monitoring market where rivals are still building their own coverage cases.
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Tuesday 11 November
Eli Lilly signed three pipeline deals, spread across RNA medicine, gene therapy and AI.
It agreed to pay SanegeneBio up to $1.2bn in milestones, plus an upfront payment and equity, for a global RNAi collaboration in cardiometabolic disease built on Sanegene’s tissue-targeting delivery platform, with dosing potentially as infrequent as twice a year.
It bought worldwide rights to MeiraGTx’s AAV gene therapy for a form of childhood blindness, Leber congenital amaurosis type 4, for up to $475m, after the therapy produced vision gains in all 11 children treated.
Lastly, it committed >$100m to Insilico Medicine to widen its use of the biotech’s Pharma.AI discovery platform. The three together buy Lilly early- and mid-stage optionality in metabolic disease, ophthalmology and computational discovery, at a price that is mostly contingent.
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SanegeneBio announces RNAi licensing and research collaboration with Lilly - SanegeneBio
MeiraGTx enters strategic collaboration with Eli Lilly and Company - MeiraGTx
Insilico and Lilly enter a research and licensing collaboration to advance AI-driven drug discovery - Insilico Medicine
MGI Tech and South Africa launched a programme to sequence 110,000 genomes.
The Chinese sequencing firm signed a memorandum with the South African Medical Research Council and the Department of Science, Technology and Innovation to build the country’s first national genomic reference database, starting with a pilot of up to 10,000 genomes. The programme put Africa’s first DNBSEQ-T7 sequencer to work at the SAMRC’s centre in Cape Town. A state-backed programme at this scale sets a country’s genomic infrastructure, and its vendor, for years.
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MGI Tech joins forces with SAMRC and DSTI to launch South Africa’s 110K Human Genome Program - MGI Tech
Wednesday 12 November
The FDA named Richard Pazdur, its longtime oncology chief, to run the centre that reviews nearly all new drugs.
Pazdur takes over the Center for Drug Evaluation and Research (CDER) a week after its previous director, George Tidmarsh, resigned abruptly. A 26-year veteran and the founding head of the agency’s Oncology Center of Excellence, he will keep running that until a successor is found. Commissioner Marty Makary called him a regulatory innovator; the industry will read the appointment as a steadying hand at CDER.
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The UK published a roadmap to phase out animal testing.
Of a total of £75m investment, £60m will fund a central hub pulling together data, technology and expertise, and £16m is committed jointly by the Medical Research Council, Innovate UK and the Wellcome Trust for human-relevant laboratory models. The government set firm milestones: an end to animal testing for skin and eye irritation in new drug development by the end of 2026, and removal of mouse testing for botulinum toxin by 2027. Scientists cautioned that for many uses there is still no meaningful alternative to animals.
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The UK narrowed its science pact with China, cutting sensitive fields out of state-backed work.
After a meeting in Beijing, the two countries signed an updated agreement that limits government-supported collaboration to four areas: health, climate and environment, planetary sciences and astronomy, and agriculture and food. The text notes that some sub-sectors sit outside government support on national-security grounds. The 2017 deal it replaces had also covered satellites, remote-sensing technology and robotics, which are now absent; the Financial Times reported the change as a security-driven scaling back, made even as a senior minister called China a strong scientific nation.
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Joint statement from the 11th UK and China Joint Commission Meeting - gov.uk
UK scales back science and technology collaboration with China over security risks - Financial Times
Grail set an early-2026 FDA filing for Galleri as its revenue grew.
Q3 revenue rose 26% to $36.2m, with Galleri sales up 29% to $32.8m on >45,000 tests sold. The company said it expects to complete its premarket approval submission to the FDA in the first quarter of 2026, the first firm regulatory marker for a blood test it has so far sold as a laboratory-developed test. An approval decision would shape the still-unproven market for multi-cancer screening.
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Thursday 13 November
Novartis’s next-generation malaria drug beat the standard of care and held up against resistant parasites.
The Phase III KALUMA trial of KLU156, branded GanLum, met its primary endpoint of non-inferiority to Coartem, with a PCR-corrected cure rate of 97.4% against 94.0%. GanLum combines ganaplacide, a compound with an entirely new mechanism, and a new once-daily formulation of lumefantrine; further analysis showed it was highly effective against mutant parasites tied to partial drug resistance. Developed with the Medicines for Malaria Venture, it would be the first major non-artemisinin advance in malaria treatment since 1999, as resistance to the artemisinin-based therapies spreads.
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Novartis Phase III trial of next-generation malaria treatment KLU156 (GanLum) meets primary endpoint - Novartis
Siemens will hand most of its Siemens Healthineers stake to its own shareholders.
The engineering group said it plans to deconsolidate the medical-technology maker by transferring 30% of its shares directly to Siemens AG holders, a route it called the preferable option. That drops its stake from about 67% to 37% or below, with the aim of falling under 20% over time. A shareholder vote is set for the February 2027 annual meeting, and the move hands one of Europe’s largest imaging and diagnostics firms a much freer float.
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Friday 14 November
Merck agreed to buy Cidara Therapeutics for about $9.2bn, taking on a long-acting flu drug J&J once handed back.
The all-cash offer of $221.50 a share is a 109% premium. Cidara’s lead asset, CD388, pairs a neuraminidase inhibitor with an antibody Fc fragment to prevent influenza A and B in a single dose, and is in the Phase 3 ANCHOR study; Cidara reacquired it from J&J in 2024. For Merck the logic is that Keytruda loses exclusivity from 2028, and preventive respiratory assets are one way to fill the gap. The deal is expected to close in Q1 2026.
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Merck to acquire Cidara Therapeutics, Inc., diversifying its portfolio to include late-phase antiviral agent - Merck & Co
BMS and J&J stopped a phase 3 trial of their blood thinner for futility.
The Librexia ACS study tested milvexian, an oral Factor XIa inhibitor, in patients after an acute coronary syndrome; a preplanned interim look found it unlikely to hit its primary efficacy goal, with no new safety concerns. The failure closes one route for a molecule the partners had tipped for multibillion-dollar sales. The two other Librexia studies, in atrial fibrillation and secondary stroke prevention, continue, with data due in 2026.
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Update on Phase 3 Librexia ACS trial - Bristol Myers Squibb
Lundbeck gatecrashed Alkermes’ agreed deal for Avadel with a higher offer.
Avadel disclosed an unsolicited proposal from Lundbeck worth up to $23.00 a share: $21.00 in cash plus a contingent right of up to $2.00 tied to sales of its narcolepsy medicine Lumryz and of valiloxybate, valuing the company at $2.4bn. That tops the up-to-$20.00 a share Avadel agreed with Alkermes in late October, and its board judged the Lundbeck approach the superior offer. Avadel’s sleep-medicine business now has a live contest around it.
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Avadel receives unsolicited proposal from Lundbeck - Avadel Pharmaceuticals
The FDA approved Kura Oncology and Kyowa Kirin’s menin inhibitor for a form of acute leukaemia.
KOMZIFTI (ziftomenib), an oral drug, was cleared for adults with relapsed or refractory NPM1-mutated acute myeloid leukaemia (AML), the first once-daily targeted therapy for that group. Approval rested on the KOMET-001 trial in 112 patients, which showed a 21.4% rate of complete remission or complete remission with partial haematologic recovery and a median response lasting 5.0 months. The clearance gives Kura its first marketed product and validates Kyowa Kirin’s bet on the partnership struck a year earlier.
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