Clinical trial coverage on Peptide News Digest pulls in Phase 1 through Phase 3 readouts across the peptide universe — GLP-1 obesity and cardiometabolic trials (SELECT, SURMOUNT-4, ACHIEVE-3, REDEFINE-1, SYNCHRONIZE-1), peptide vaccine work (AMPLIFY-201, MEL39), peptide-drug conjugate trials, and antimicrobial peptide programs.
Most of the noise sits with Lilly and Novo, but the interesting reads are usually elsewhere: Bicycle Therapeutics on solid tumors, Lirum on Ewing sarcoma, Cerapedics on lumbar fusion, Pelage on hair loss. Real-world evidence and registry data also land here when they reframe what the randomized trials showed.
Each entry names the sponsor, the phase, and the endpoint. Browse the latest below, or jump to the readouts by drug at #semaglutide, #tirzepatide, or #orforglipron.
The 26th International AIDS Conference (AIDS 2026) opens Sunday July 26, 2026 in Rio de Janeiro, Brazil and runs through July 31. Gilead Sciences and Merck's Phase 3 ISLEND-1 and ISLEND-2 detailed data on the investigational once-weekly oral HIV treatment regimen islatravir 2 mg / lenacapavir 300 mg (ISL/LEN) is scheduled for the late-breaking session on Wednesday July 29. Topline numbers released July 21 showed 0% of once-weekly ISL/LEN participants had HIV-1 RNA at 50 copies/mL or higher at Week 48 in ISLEND-1 (versus 0.3% of participants who remained on daily Biktarvy). In ISLEND-2, 0.3% of participants receiving weekly ISL/LEN had HIV-1 RNA at 50 copies/mL or higher versus 1.3% on daily standard of care regimens. Safety profile was generally similar to comparator regimens with no new signals identified. Lenacapavir is a first-in-class HIV capsid inhibitor (peptide-adjacent modality); islatravir is a nucleoside reverse transcriptase translocation inhibitor (NRTTI). The data will support planned regulatory submissions and represents the first once-weekly oral HIV treatment regimen to clear Phase 3 endpoints. Merck also plans to present daily, weekly, and monthly HIV treatment and prevention pipeline updates at AIDS 2026.
Arrowhead Pharmaceuticals (NASDAQ: ARWR) reported positive Phase 3 topline results Thursday July 23, 2026 from the SHASTA-3 and SHASTA-4 studies of plozasiran, an ApoC-III-targeting siRNA administered as a 25 mg subcutaneous injection once every three months, in adults with severe hypertriglyceridemia (sHTG). Both trials met their primary endpoint: median triglyceride reductions of 79% (SHASTA-3) and 81% (SHASTA-4) at Month 12 versus approximately 27% for placebo. All prespecified secondary endpoints were met, including a statistically significant reduction in the rate of acute pancreatitis events compared with placebo. Arrowhead shares rose approximately 19% on the readout. The company plans to file a supplemental New Drug Application (sNDA) with the US FDA before the end of 2026 for the sHTG indication (which extends the current Redemplo label from familial chylomicronemia syndrome), and Arrowhead intends to use the SHASTA-3, SHASTA-4, and MUIR-3 program data for marketing authorization filings across multiple global geographies. Plozasiran is a nucleic-acid therapeutic (siRNA), an adjacent-modality to peptides that operates through RNA interference at the ApoC-III gene expression level to lower circulating triglycerides.
Boehringer Ingelheim announced Thursday July 16, 2026 the start of a Phase 2 clinical trial evaluating BI 3034701, its investigational triple GLP-1/GIP/NPY2 receptor agonist peptide, in patients with obesity and overweight. BI 3034701 is a potential first-in-class triple agonist designed to activate three complementary biological pathways: GLP-1 and GIP receptors reduce appetite and regulate metabolism, and the neuropeptide Y2 (NPY2) receptor modulates central hunger signaling. Phase 1 studies previously showed a generally favorable safety and tolerability profile that supported advancing the program. BI 3034701 is based on Gubra-discovered technology and licensed to Boehringer Ingelheim, which is responsible for global clinical development and commercialization. The program adds a distinct third target to the emerging next-generation obesity landscape: Eli Lilly's retatrutide (GLP-1/GIP/glucagon triple agonist in TRIUMPH Phase 3), Novo Nordisk's UBT251 (GLP-1/GIP/glucagon triple in Phase 1/2a), and Boehringer's dual glucagon/GLP-1 survodutide (Phase 3, 16.6% weight loss in obesity). The NPY2 receptor target is novel to the class and could carry a distinct safety and tolerability profile alongside the incretin-plus-incretin backbone.
Eli Lilly (NYSE: LLY) presented Kisunla (donanemab-azbt) modified titration regimen data and TRAILBLAZER-ALZ 2 long-term extension results at AAIC 2026 in London on Wednesday July 15, 2026 during the closing-day Developing Topics Session titled 'Donanemab in Early Symptomatic Alzheimer's Disease: Evidence to Address Clinical Questions.' The modified titration regimen for Kisunla used a 350 mg starting dose ramping to the standard 1,400 mg by week 4, which significantly reduced cases of ARIA-E (amyloid-related imaging abnormalities with edema) brain swelling relative to the standard titration schedule. The Phase 3 TRAILBLAZER-ALZ 2 long-term extension data documented that patients who met the criteria for ending treatment at 52 weeks maintained low amyloid levels through 154 weeks of follow-up, with an amyloid reaccumulation rate of 2.4 centiloid per year (comparable to the natural accumulation rate seen in untreated cognitively unimpaired individuals). John Sims, Eli Lilly senior medical director, framed the readout around a 1,400 mg once-yearly maintenance-dose hypothesis: 'If someone needed it, [1,400 mg once a year] could potentially keep that amyloid down and keep it low and steady.' Lilly is running an addendum study of the TRAILBLAZER-ALZ 6 trial to characterize the ability of a maintenance dose given at least a year after original treatment completion to sustain amyloid clearance.
Biogen (NASDAQ: BIIB) presented full Phase 2 CELIA study data for diranersen (BIIB080), an investigational tau-targeting antisense oligonucleotide (ASO) delivered intrathecally, at AAIC 2026 in London on Tuesday July 14, 2026 during the Developing Topics in Phase 2 Clinical Trials Session (2:00-3:30 PM BST). The 76-week placebo-controlled study evaluated three doses (60 mg every 24 weeks, 115 mg every 24 weeks, and 115 mg every 12 weeks) and did not meet its primary endpoint of dose response on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at Week 76. Strong reductions in tau pathology occurred across all studied doses, generally consistent with the Phase 1b study. Prespecified analyses of cognitive endpoints demonstrated slowing of clinical decline across all doses, with the effect particularly pronounced at the lowest 60 mg q24w dose. Biogen framed the results as the first randomized Phase 2 evidence of a tau-directed therapy showing both biomarker impact and cognitive benefit, and plans to advance diranersen to registrational Phase 3 development.
Eisai and Biogen announced Tuesday July 14, 2026 that data from the real-world Lecanemab in Early Alzheimer's Disease (LEADER) Study, presented at AAIC 2026 in London during the Developing Topics Session '#3-33-DEV-A: Lecanemab Three Years Post-Approval: A Comprehensive Multicenter, Real-World, Retrospective Study (LEADER) in Diverse US Clinical Settings,' documented durable clinical outcomes with LEQEMBI in early Alzheimer's disease. The analysis included 432 early Alzheimer's disease patients from diverse US clinical settings who had received at least seven LEQEMBI infusions as of May 2026. Over an average of 17 months of treatment, 75.9% of patients remained clinically stable and 6.6% improved (moving from mild Alzheimer's disease dementia to mild cognitive impairment due to Alzheimer's disease). 87% of patients chose to remain on LEQEMBI treatment. Results were consistent across sex, race, ethnicity, and APOE genotype, supporting long-term benefits of continuous treatment outside of a controlled clinical trial setting.
Vaccinex (NASDAQ: VCNX) presented new biomarker data from the Phase 1b/2 SIGNAL-AD trial of pepinemab, a humanized IgG4 monoclonal antibody targeting Semaphorin 4D (SEMA4D), at AAIC 2026 in London on Monday July 13, 2026 from 9:00-10:30 AM London time at ExCeL London. Elizabeth Evans, PhD, Chief Operating Officer and Senior VP of Discovery and Translational Medicine, chaired the Featured Research Session 'Alzheimer's therapy: mechanisms beyond amyloid' and presented results titled 'Glial Biomarkers Associated With Disease Progression Are Regulated By SEMA4D Blocking Antibody Pepinemab in Patients With Early-Stage AD.' The presentation showed that SEMA4D blockade regulates glial biomarkers associated with disease progression in early Alzheimer's disease, supporting the mechanistically distinct approach of targeting neuroinflammation and reactive astrocytes rather than amyloid or tau directly. Vaccinex outlined plans for an enlarged Phase 2b SIGNAL-AD2 study to test the intervention at scale.
Voyager Therapeutics (NASDAQ: VYGR) presented six-month Good Laboratory Practice (GLP) toxicology data for VY1706, its investigational blood-brain-barrier-crossing AAV gene therapy targeting tau for Alzheimer's disease, in a Developing Topics late-breaking poster at AAIC 2026 in London on Monday July 13, 2026. The updated six-month data extends the prior three-month timepoint (64% reduction reported earlier this month): a single intravenous dose delivered sustained tau protein reduction up to 75% in key brain regions of non-human primates over six months. VY1706 was well tolerated with no adverse clinical pathology and no histopathological findings up to the highest dose tested. Notably, the program showed none of the typical AAV liver transaminase elevations at any dose level throughout six months, plasma neurofilament levels remained generally stable with no dose-related increases, and there were no cellular immune activations. Voyager received FDA Investigational New Drug (IND) clearance for VY1706, enabling initiation of a clinical trial in adults with early Alzheimer's disease with dosing expected in the second half of 2026.
Eisai announced Monday July 13, 2026 that its investigational anti-microtubule-binding region (MTBR) tau antibody etalanetug (development code E2814) reduced levels of plasma extracellular MTBR-tau243 (eMTBR-tau243), a novel fluid biomarker of Alzheimer's disease tau tangle pathology, in findings presented during a Featured Research Session at AAIC 2026 in London. Etalanetug reduced plasma eMTBR-tau243 by 78% at 3 months and by more than 90% at 9 months. The biomarker was largely absent in healthy adults and detected only in patients with dominantly inherited Alzheimer's disease (DIAD), suggesting it reflects disease-related tau pathology at the pathological source (neurofibrillary tangle formation) rather than tau physiology broadly. eMTBR-tau243 consists of tau fragments that include amino acid residue 243 and MTBR sequences, arising during the formation of neurofibrillary tangles, and can now be measured with a blood test to track tau pathology non-invasively. Etalanetug is Eisai's second-generation Alzheimer's antibody program beyond lecanemab (LEQEMBI, amyloid protofibril-directed), extending the company's franchise from amyloid to tau.
Longeveron (NASDAQ: LGVN) presented additional CLEAR MIND Phase 2a clinical data analysis for laromestrocel, its investigational allogeneic mesenchymal stem cell (Medicinal Signaling Cell) therapy, at AAIC 2026 in London on Monday July 13, 2026 from 7:30 AM-4:15 PM BST. The poster titled 'Laromestrocel Stabilizes Brain Inflammation In Key Alzheimer's Disease Gray And White Matter Regions As Assessed Using Free Water MRI' extends the CLEAR MIND Phase 2a program that Longeveron first published in Nature Medicine in March 2025. Free water MRI, a diffusion-based imaging technique that quantifies extracellular water and correlates with neuroinflammation, showed that laromestrocel-treated patients maintained stable brain inflammation levels in key gray and white matter regions relevant to Alzheimer's disease pathology. The findings support a clinically relevant and durable anti-inflammatory mechanism of action for laromestrocel and indicate potential blood biomarker correlates for tracking treatment response. Laromestrocel is administered as an intravenous infusion; the program targets neuroinflammation as a disease-modifying mechanism distinct from amyloid and tau approaches.
Denali Therapeutics (NASDAQ: DNLI) co-founder and CEO Ryan Watts, PhD delivered the opening plenary address at the Alzheimer's Association International Conference (AAIC) 2026 in London on Sunday July 12, 2026, titled 'Accelerating the Discovery and Development of Medicines for Neurodegeneration.' The presentation covered advances in neurodegeneration biology, biomarkers for diagnosis and treatment-effect assessment, and biologic therapies designed to cross the blood-brain barrier. Denali's proprietary TransportVehicle (TV) platform leverages the body's iron transport system (transferrin receptor) to shuttle antibodies, enzymes, and oligonucleotides into the brain. AVLAYAH (tividenofusp alfa-eknm) received FDA accelerated approval March 2026 as the first FDA-approved biologic specifically designed to cross the blood-brain barrier, for the treatment of neurologic manifestations of Hunter syndrome in certain pediatric patients. DNL628 is enabled by Denali's Oligonucleotide TransportVehicle (OTV) and targets the MAPT gene encoding tau, with data expected 1H 2027; DNL921 is a separate Alzheimer's candidate with Phase 1/2b data expected in 2027. The plenary framing ties to the Lonza-Nona Biosciences TfR1 blood-brain-barrier deal covered in Saturday's digest.
Eisai and Biogen announced Sunday July 12, 2026 that new clinical data presented at AAIC 2026 in London support that the LEQEMBI (lecanemab) subcutaneous autoinjector (SC-AI) formulation offers efficacy and safety comparable to intravenous (IV) administration in people with early Alzheimer's disease. Data were featured during the Developing Topics Session titled 'Lecanemab Subcutaneous Formulation in Early Alzheimer's Disease: Emerging Clinical Evidence and Practical Use Considerations,' covering the SC formulation, long-term use across diverse patient groups, maintenance dosing, and at-home administration. The findings support a fully subcutaneous treatment pathway from initiation through maintenance treatment, offering greater convenience and flexibility for patients and care partners. The FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025; the SC autoinjector data at AAIC 2026 extends that framework to initial treatment and long-term dosing. Lecanemab is a humanized IgG1 monoclonal antibody selective for amyloid protofibrils; the July 12 dataset is peptide-adjacent to the broader biologic-CNS delivery coverage.
Voyager Therapeutics (NASDAQ: VYGR) presented Developing Topics late-breaking poster data at AAIC 2026 in London (July 12-15) featuring VY1706, its investigational blood-brain-barrier-crossing AAV gene therapy targeting intracellular and extracellular tau for Alzheimer's disease. The 3-month GLP non-human primate toxicology study showed VY1706 was well tolerated at a single intravenous dose up to the highest level tested (5E13 vg/kg), with no adverse clinical pathology or histopathological findings. Tau protein was reduced up to 64% in key brain regions of non-human primates at 13 weeks following a single IV dose. Voyager received FDA Investigational New Drug (IND) clearance for VY1706 in H1 2026, enabling initiation of a clinical trial in adults with early Alzheimer's disease with dosing expected in the second half of 2026. The program extends the same BBB-delivery-plus-tau-reduction thesis that Denali's DNL628 OTV pursues via anti-tau ASO; both address the same therapeutic hypothesis through different modalities (AAV gene therapy vs. anti-sense oligonucleotide).
Biogen (NASDAQ: BIIB) will present Phase 2 CELIA study data for diranersen (BIIB080), an investigational tau-targeting antisense oligonucleotide (ASO), at AAIC 2026 in London during the Developing Topics in Phase 2 Clinical Trials session on Tuesday July 14, 2:00–3:30 PM BST. The 18-month CELIA study evaluated diranersen in patients with early Alzheimer's disease and is the first study to show reduction in tau pathology and cognitive benefit for a tau-targeted therapy. Biogen will present clinical, biomarker, and safety data that build on the May 2026 topline announcement and further characterize the molecule as the program advances toward Phase 3 development. Diranersen targets MAPT RNA to reduce tau production at its source, a differentiated approach to addressing abnormal tau both inside and outside neurons. The CELIA readout is a peptide-adjacent nucleic-acid biologic milestone that shifts the tau treatment conversation from 'reducing pathology' to 'reducing pathology and moving cognition.'
Acumen Pharmaceuticals (NASDAQ: ABOS) will present data on its Enhanced Brain Delivery (EBD) technology and early Alzheimer's disease insights for sabirnetug (ACU193) at AAIC 2026 in London (July 12-15, both in-person and online). Sabirnetug is a humanized monoclonal antibody discovered and developed based on its selectivity for soluble amyloid-beta oligomers (AβOs, a highly toxic and pathogenic form of Aβ) relative to Aβ monomers and amyloid plaques. Soluble AβOs bind to neurons, inhibit synaptic function, and induce neurodegeneration; the mechanism differentiates sabirnetug from plaque-directed anti-amyloid antibodies (lecanemab, donanemab) that clear fibrillar Aβ. Acumen advances sabirnetug in the ongoing Phase 2 ALTITUDE-AD trial in early symptomatic AD, following positive Phase 1 INTERCEPT-AD results. Topline ALTITUDE-AD results are expected in late 2026. The Enhanced Brain Delivery technology component further connects to the day's broader BBB-delivery theme anchored on Denali's opening plenary and the Lonza-Nona deal.
The Alzheimer's Association International Conference (AAIC 2026) opens Sunday July 12 and runs through Wednesday July 15 at the ExCeL London, drawing approximately 12,000 researchers and health-care professionals from around the globe. The peptide-adjacent centerpiece already flagged in Wednesday's Vaccinex announcement is the Featured Research Session on Monday July 13 for pepinemab (humanized IgG4 anti-Semaphorin 4D monoclonal antibody), chaired by Elizabeth Evans, PhD, presenting new glial biomarker data from the Phase 1b/2 SIGNAL-AD study alongside plans for the expanded Phase 2b SIGNAL-AD2 trial. AC Immune (NASDAQ: ACIU) will present three programs from its Morphomer platform: a first-in-class TDP-43 PET tracer with encouraging early human imaging data in frontotemporal dementia and ALS, a novel brain-penetrant NLRP3 inhibitor in Phase 1 that supports an orally delivered CNS therapy profile, and an alpha-synuclein Morphomer showing potent, brain-penetrant inhibition of pathology with neuroprotective effects. Eisai will present 50-plus abstracts spanning the lecanemab (LEQEMBI) Alzheimer's disease portfolio, including biomarker, long-term safety, and clinical-utility readouts.
AstraZeneca and Ionis Pharmaceuticals announced Thursday July 9, 2026 that the Phase 3 CARDIO-TTRansform trial of Wainua (eplontersen) did not meet its primary efficacy endpoint in adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). The trial enrolled over 1,400 patients and was the largest Phase 3 study conducted in the ATTR-CM population to date; the primary endpoint was a composite of cardiovascular mortality and recurrent CV clinical events through 140 weeks compared with placebo. Prespecified subgroup analyses showed nominally significant reductions in composite events with eplontersen monotherapy versus placebo, while patients also receiving a baseline TTR stabilizer showed no incremental effect. Eplontersen is an antisense oligonucleotide (a nucleic-acid therapeutic modality distinct from peptides but adjacent in the metabolic-and-cardiovascular therapeutic territory this site tracks); the drug is already FDA-approved as Wainua for hereditary transthyretin amyloidosis polyneuropathy. Full CARDIO-TTRansform results will be presented at the European Society of Cardiology (ESC) Congress in August 2026. AstraZeneca and Ionis shares fell on the readout.
Vaccinex (NASDAQ: VCNX) announced Wednesday July 8, 2026 that it will present new glial biomarker data from the Phase 1/2 SIGNAL-AD study of pepinemab and plans for the expanded Phase 2B SIGNAL-AD2 trial at the Alzheimer's Association International Conference (AAIC) 2026 in London on July 13. Elizabeth Evans, PhD, Chief Operating Officer and Senior VP of Discovery and Translational Medicine, will chair the Featured Research Session. Pepinemab is a humanized IgG4 monoclonal antibody targeting Semaphorin 4D (SEMA4D). The mechanism blocks SEMA4D signaling through astrocyte plexin-B1 receptors, reducing reactive astrocyte activation and downstream neuroinflammation — a disease-modifying approach mechanistically distinct from amyloid- or tau-targeting strategies. Pepinemab is a monoclonal antibody rather than a peptide, but the SEMA4D program sits in the peptide-and-biologic neurodegeneration territory this site tracks alongside the Vera Therapeutics Trutakna (atacicept fusion protein) approval covered yesterday. AAIC readouts to watch: cerebrospinal-fluid glial fibrillary acidic protein (GFAP) and neurofilament light chain (NfL) biomarker shifts on pepinemab treatment.