Last Week in Biomedicine

About Last Week in Biomedicine

Every Tuesday, we break down 10 of the most significant biopharma stories and buzzworthy clinical trial breakthroughs from the previous week. The podcast highlights major Phase 2 and Phase 3 trial results, breakthrough therapies, biotech innovations, FDA updates, and emerging treatments shaping the future of medicine. From obesity and cancer to autoimmune disease, neurodegeneration, cardiovascular disease, diabetes, and rare genetic disorders, each episode delivers a fast, accessible look at the data, discoveries, and therapies driving the next generation of healthcare.

Publisher

TrialBreaks

Category

health & fitness

Language

en

Explicit

No

First episode

12 May 2026

Latest episode

9 Jul 2026

Latest episodes

17 episodes in the feed.

1. 

   9 Jul 2026

   Last Week in Biomedicine | Jun 29–Jul 3 | Part 2 of 2: Baby Pompe Disease Trial, DLBCL Combo Win

   Part 2 covers three more standout stories from the same week: a Phase 3 trial that gives babies with a devastating enzyme disease a fighting chance, a first-of-its-kind cell therapy approved to make bone-marrow transplants safer, and a new lymphoma combination that could give aggressive-blood-cancer patients another option after other therapies fail. In Part 2 we cover: 4. Sanofi — Nexviazyme (avalglucosidase alfa) for infantile-onset Pompe disease (Phase 3) 5. Orca Bio — Tregzi (allogeneic regulatory T-cell immunotherapy) for adults with blood cancers undergoing matched-donor bone-marrow transplant (FDA approval) 6. Genmab / AbbVie — Epkinly (epcoritamab) plus lenalidomide for relapsed or refractory diffuse large B-cell lymphoma (Phase 3) What could this mean for patients? The Sanofi Baby-COMET result is the most emotionally consequential story of the week. Infantile-onset Pompe disease is usually fatal in a baby's first year without treatment, and a Phase 3 trial hitting every primary and secondary endpoint means more infants may reach toddlerhood breathing on their own — an outcome that was unimaginable a generation ago. Catch Part 1 if you missed it. Subscribe at TrialBreaks.com. #biomedicine #clinicaltrials #science #Pompedisease #enzymereplacement #rarediseases #genetherapy #celltherapy #bonemarrowtransplant #GVHD #hematology #lymphoma #DLBCL #bispecificantibody #immunotherapy #oncology

2. 

   7 Jul 2026

   Last Week in Biomedicine | Jun 29–Jul 3 | Part 1 of 2: CRISPR for Toddlers, KRAS Lung Cancer Win

   CRISPR gene editing crossed a major line this week: the FDA now allows Casgevy — the first CRISPR therapy of any kind — for children as young as 2 with sickle cell disease, meaning we can potentially prevent a lifetime of pain crises and organ damage instead of treating them after the fact. Part 1 also digs into a rare kind of trial where a new lung cancer drug takes on the already-approved competition, and a New England Journal of Medicine paper on the first oral pill for a form of childhood dwarfism. In Part 1 we cover: 1. Vertex Pharmaceuticals / CRISPR Therapeutics — Casgevy (exagamglogene autotemcel) for sickle cell disease and transfusion-dependent beta thalassemia in children ages 2 and up (FDA approval — label expansion) 2. Roche / Genentech — divarasib for KRAS G12C-mutant non-small cell lung cancer (Phase 3) 3. BridgeBio Pharma / Kyowa Kirin — oral infigratinib for achondroplasia in children (Phase 3, published in NEJM) What could this mean for patients? Casgevy in toddlers is the story with the biggest potential ripple effect. Sickle cell disease starts hurting kids in infancy, so treating a 2-year-old before repeated strokes and organ damage sets in could redefine what growing up with sickle cell looks like. It's also a proof point that CRISPR-based cures can be delivered safely in very young children — a green light for other pediatric gene-editing programs in development. Part 2 drops Thursday morning. Subscribe at TrialBreaks.com. #biomedicine #clinicaltrials #science #CRISPR #genetherapy #sicklecell #lungcancer #KRAS #achondroplasia #oncology #rarediseases #pediatrics #hematology #NEJM #immunotherapy

3. 

   2 Jul 2026

   Last Week in Biomedicine | June 22–26 | Part 2 of 2: Thyroid Eye Disease, ADHD + Anxiety, Skyrizi Kids

   Part 2 covers a new drug for the bulging-eye autoimmune disease, the first Phase 3 ADHD trial designed for patients who also have anxiety, and a major pediatric expansion for a top-selling psoriasis biologic. In Part 2 we cover: 4. Viridian Therapeutics — Lumvoa (veligrotug) for thyroid eye disease, active and chronic (FDA approval) 5. Otsuka Pharmaceutical — centanafadine for adult ADHD with comorbid anxiety (Phase 3b) 6. AbbVie — Skyrizi (risankizumab) for pediatric plaque psoriasis and psoriatic arthritis (FDA approval) The biggest story in Part 2: Lumvoa is only the second IGF-1 receptor antibody ever approved for thyroid eye disease, but it has a much broader label than its predecessor — covering both the active early form and the chronic long-standing form that affects far more patients. For people who've lived with bulging eyes and double vision for years and were told nothing could help, this approval is genuinely new ground. Catch Part 1 if you missed it. Subscribe at TrialBreaks.com. #biomedicine #clinicaltrials #science #ophthalmology #thyroideyedisease #ADHD #anxiety #mentalhealth #dermatology #psoriasis #pediatrics #immunology #FDAapproval #autoimmune #IL23

4. 

   30 Jun 2026

   Last Week in Biomedicine | June 22–26 | Part 1 of 2: LSD Depression Phase 3, Trodelvy TNBC Approval

   This week, an LSD-based therapy hit its main goal in a Phase 3 depression trial — and two huge breast cancer approvals landed at the FDA on the same week. In Part 1 we cover: 1. Definium Therapeutics — DT120 (LSD-based orally disintegrating tablet) for major depressive disorder (Phase 3) 2. Gilead Sciences / Merck — Trodelvy (sacituzumab govitecan) ± Keytruda for first-line PD-L1+ metastatic triple-negative breast cancer (FDA approval) 3. Pfizer — Ibrance (palbociclib) + trastuzumab ± pertuzumab for HR+/HER2+ metastatic breast cancer maintenance (FDA approval based on Phase 3 PATINA) The biggest story: Definium's Emerge trial showed a single dose of DT120 produced rapid relief from major depression that lasted weeks — the first time an LSD-based therapy has cleared a pivotal Phase 3 in this disease. After years of mixed results for psilocybin and MDMA programs, this readout could reopenthe door for psychedelic medicines and give patients who don't respond to standard antidepressants a fundamentally new option. Part 2 drops Thursday morning. Subscribe at TrialBreaks.com. #biomedicine #clinicaltrials #science #psychiatry #depression #psychedelics#oncology #breastcancer #immunotherapy #ADC #FDAapproval #neuroscience#womenshealth #cancerresearch

5. 

   25 Jun 2026

   Last Week in Biomedicine | June 14–20 | Part 2 of 2: Mezigdomide Myeloma, HCM Heart Drug

   Part 2 of our week of June 14–20, 2026 wrap-up covers a new molecular glue for relapsed multiple myeloma that cut disease progression by half, a heart drug that may finally work forboth forms of hypertrophic cardiomyopathy, and a new combination regimen poised to upgrade the first-line standard of care in myelofibrosis. In Part 2 we cover:4. Bristol Myers Squibb — Mezigdomide for relapsed/refractory multiple myeloma (Phase 3) 5. Edgewise Therapeutics — EDG-7500 for obstructive and non-obstructive hypertrophic cardiomyopathy (Phase 2) 6. Karyopharm Therapeutics / Menarini — Selinexor plus ruxolitinib for first-line myelofibrosis (Phase 3) The most patient-impactful of these three is probably the Edgewise heart drug. Hypertrophic cardiomyopathy — a too-thick heart muscle that makes it hard to pump blood — is the most common inherited heart disease, but today'smyosin-inhibitor drugs only help people whose blood flow is physically blocked. EDG-7500 showed clear improvements in both the obstructive and non-obstructive forms, potentially more than doubling the number of patients who could benefit. Catch Part 1 if you missed it. Subscribe at TrialBreaks.com. #biomedicine #clinicaltrials #science #oncology #cardiology #hematology#myeloma #HCM #cardiomyopathy #myelofibrosis #CELMoD #sarcomere#drugdevelopment #precisionmedicine

6. 

   23 Jun 2026

   Last Week in Biomedicine | June 14–20 | Part 1 of 2: CRISPR HAE Cure, Narcolepsy Orexin Breakthrough

   This week opened with one of the most significant gene-editing milestones in clinical medicine: a single CRISPR infusion cut hereditary angioedema attacks by 87 percent in a Phase 3 trial, published the same day in the New England Journal of Medicine. Plus a first-in-class drug that may reshape how we treat narcolepsy, and the first new oral antifungal class in over 20 years. In Part 1 we cover: 1. Intellia Therapeutics — Lonvoguran ziclumeran (lonvo-z) for hereditary angioedema (Phase 3) 2. Takeda Pharmaceutical — Oveporexton (TAK-861) for narcolepsy type 1 (Phase 3) 3. F2G / Shionogi — Olorofim for invasive aspergillosis (Phase 3) The Intellia readout is the headline of the week. Hereditary angioedema causes sudden, painful and sometimes life-threatening swelling attacks, and current treatments require regular injections to suppress them. Lonvo-z is given once — a tiny package of CRISPR machinery shuts down the gene responsible for the attacks inside liver cells permanently — and 81 percent of patients were completely attack-free at one year. If this holds up, an entire category of chronic disease management could be replaced by single-dose curative gene editing. Part 2 drops Thursday morning. Subscribe at TrialBreaks.com. #biomedicine #clinicaltrials #science #CRISPR #genetherapy #raredisease #neurology #narcolepsy #orexin #infectiousdisease #antifungal #immunology #HAE #aspergillosis #drugdevelopment

7. 

   18 Jun 2026

   Last Week in Biomedicine | June 6–13 | Part 2 of 2: CagriSema Diabetes, Sickle Cell Plenary

   Part 2 of our June 6–13 wrap-up: Novo Nordisk's CagriSema beats semaglutide alone in three Phase 3 diabetes trials, Takeda's zasocitinib pill outperforms Sotyktu head-to-head in psoriasis, and Agios's mitapivat headlines the EHA Plenary with breakthrough Phase 3 sickle cell data. In Part 2 we cover: 4. Novo Nordisk — CagriSema (cagrilintide + semaglutide) for type 2 diabetes (Phase 3) 5. Takeda — Zasocitinib for moderate-to-severe plaque psoriasis (Phase 3) 6. Agios Pharmaceuticals — Mitapivat for sickle cell disease (Phase 3) Mitapivat is a once-daily pill that flips on an enzyme inside red blood cells so they can make more energy and resist the sickling that causes excruciating pain crises. The Phase 3 RISE UP data, presented at the prestigious EHA 2026 Plenary, showed it both raises hemoglobin and cuts pain crises — a long-overdue option for a disease with very few approved therapies that disproportionately affects Black communities globally. Catch Part 1 if you missed it. Subscribe at TrialBreaks.com. #biomedicine #clinicaltrials #science #diabetes #GLP1 #obesity #sicklecell #hematology #psoriasis #dermatology #immunology #raredisease #metabolic

8. 

   16 Jun 2026

   Last Week in Biomedicine | June 6–13 | Part 1 of 2: Retatrutide Weight Loss, Weekly HIV Pill

   A blockbuster week in biomedicine — Eli Lilly's retatrutide produced weight loss approaching bariatric surgery in Phase 3, and Gilead and Merck's once-weekly oral HIV pill cleared two Phase 3 trials. Plus the first in-vivo CRISPR therapy keeps stacking up Phase 3 wins. In Part 1 we cover:1. Eli Lilly — Retatrutide for obesity (Phase 3) 2. Gilead Sciences and Merck — Islatravir/Lenacapavir for HIV (Phase 3) 3. Intellia Therapeutics — Lonvoguran ziclumeran (lonvo-z) for hereditary angioedema (Phase 3) Retatrutide is the standout. By activating three gut hormone receptors at once — GLP-1, GIP, and glucagon — it drove mean weight loss up to about 30% in the TRIUMPH-1 trial, while also improving blood sugar, knee osteoarthritis pain, and sleep apnea. If that holds up, the next generation of obesity medicineswon't just shrink waistlines, they'll treat the cluster of conditions tied to obesity. Part 2 drops Thursday morning. Subscribe at TrialBreaks.com (TrialBreaks.com) #biomedicine #clinicaltrials #science #obesity #GLP1 #HIV #infectiousdisease #CRISPR #genetherapy #rarediseases #raredisease #metabolic #immunology

9. 

   11 Jun 2026

   Last Week in Biomedicine | May 30 – Jun 5 | Part 2 of 2: Talzenna Prostate Combo, IgG4 Disease First

   From a prostate cancer combo that uses your tumor's own broken DNA-repair against it, to the first drug ever to succeed in a rare autoimmune disease called IgG4-related disease — Part 2 of our weekly biomedicine recap covers three more major readouts from the week of May 30 – June 5, 2026. In Part 2 we cover: 4. Pfizer — Talazoparib plus enzalutamide for metastatic castration-sensitive prostate cancer with DNA-repair mutations (Phase 3) 5. Zenas BioPharma — Obexelimab for IgG4-related disease (Phase 3) 6. Karyopharm Therapeutics — Selinexor plus ruxolitinib for myelofibrosis (Phase 3) The IgG4-RD result may be the most quietly historic of the week: IgG4-related disease is a rare autoimmune condition where misbehaving B cells form fibrotic masses in organs throughout the body, and there has never been an approved therapy — patients rely on steroids long-term. Obexelimab, a clever 'bifunctional' antibody that calms B cells without killing them, cut the risk of disease flare by 56% in a 52-week Phase 3 trial — the first positive Phase 3 ever in this disease, published in the New England Journal of Medicine. We explain what makes the antibody design unusual and why a positive trial here could change rare-disease drug development more broadly. Catch Part 1 if you missed it. Subscribe at TrialBreaks.com (TrialBreaks.com) #oncology #prostatecancer #PARPinhibitor #autoimmune #IgG4 #rheumatology #rarediseases #myelofibrosis #hematology #targetedtherapy #precisionmedicine #biomedicine #clinicaltrials #science

10. 

    9 Jun 2026

    Last Week in Biomedicine | May 30 – Jun 5 | Part 1 of 2: Daraxonrasib Pancreatic Cancer, Ivonescimab Lung

    The biggest week in cancer research of 2026 dropped at the ASCO meeting in Chicago, and one drug stole the show: a new RAS-blocking pill that nearly doubled survival in metastatic pancreatic cancer, one of the deadliest diseases in medicine. In Part 1 we cover: 1. Revolution Medicines — Daraxonrasib for metastatic pancreatic cancer (Phase 3) 2. Summit Therapeutics and Akeso — Ivonescimab for first-line squamous non-small cell lung cancer (Phase 3) 3. Eli Lilly — Selpercatinib for adjuvant RET fusion-positive non-small cell lung cancer (Phase 3) Daraxonrasib targets RAS, the 'on switch' that drives roughly a third of all cancers and almost every pancreatic tumor. Unlike earlier RAS drugs that hit only one specific mutation, daraxonrasib blocks the active form of multiple RAS variants at once — and the result was a near-doubling of median overallsurvival from 6.6 months to 13.2 months in patients who had already failed first-line chemo. Doctors at the ASCO Plenary called the data 'transformative' and gave a standing ovation. We break down the science, explain why pancreatic cancer has been so untreatable, and walk through what RAS-ON inhibitors could mean for other tumors in the years ahead. Part 2 drops Thursday morning. Subscribe at TrialBreaks.com (TrialBreaks.com) #oncology #pancreaticcancer #lungcancer #precisionmedicine #RAS #immunotherapy #bispecificantibody #PD1 #targetedtherapy #ASCO2026 #biomedicine #clinicaltrials #science

11. 

    4 Jun 2026

    Last Week in Biomedicine | May 23–29 | Part 2 of 2: Apogee Eczema, TG Therapeutics MS

    In Part 2 we cover the remaining clinical trial readouts from the week of May 23–29, 2026 — a Phase 2 atopic dermatitis breakthrough and a Phase 3 multiple sclerosis convenience win. 4. Apogee Therapeutics — Zumilokibart for Moderate-to-Severe Atopic Dermatitis (Phase 2) 5. TG Therapeutics — BRIUMVI (ublituximab-xiiy) for Relapsing Forms of Multiple Sclerosis (Phase 3 ENHANCE) Apogee Therapeutics delivered a strong Phase 2 result in moderate-to-severe atopic dermatitis — 65.9% of mid-dose patients achieved a 75% reduction in disease severity at 16 weeks, compared with 23.4% on placebo. TG Therapeuticsshowed that a single Day-1 infusion of BRIUMVI gives the same drug exposure as the current two-dose initiation, simplifying multiple sclerosis treatment for thousands of patients. Catch Part 1 if you missed it. Subscribe at TrialBreaks.com (TrialBreaks.com) #dermatology #atopicdermatitis #multiplesclerosis #neurology #biomedicine #clinicaltrials #science #medicalresearch

12. 

    2 Jun 2026

    Last Week in Biomedicine | May 23–29 | Part 1 of 2: BMS Myeloma, GSK Hep B Cure, Pfizer Lung Cancer

    In Part 1 we cover the three biggest clinical trial readouts from the week of May 23–29, 2026 — including two ASCO 2026 opening-day announcements that reshape oncology. 1. Bristol Myers Squibb — Mezigdomide for Relapsed or Refractory Multiple Myeloma (Phase 3) 2. GSK — Bepirovirsen for Chronic Hepatitis B Infection (Phase 3) 3. Pfizer — LORBRENA (lorlatinib) for ALK-Positive Non-Small-Cell Lung Cancer (Phase 3, 7-year update) The biggest story: Bristol Myers Squibb's mezigdomide became the first Phase 3 win for the new CELMoD drug class, cutting disease progression risk in half for patients with relapsed or refractory multiple myeloma. The trial showed medianprogression-free survival of 18 months on mezigdomide combination versus 8.3 months on standard of care — a doubling of how long patients stay disease-stable. Part 2 drops Thursday. Subscribe at TrialBreaks.com (TrialBreaks.com) #oncology #multiplemyeloma #lungcancer #hepatitisB #biomedicine #clinicaltrials#science #medicalresearch

13. 

    28 May 2026

    Last Week in Biomedicine | May 18–22 | Part 2 of 2: Bladder Cancer Conjugate, HPV Cervical Win

    Part 2 of our May 18–22, 2026 roundup digs into a first-in-class Bicycle Toxin Conjugate for bladder cancer, a non-surgical DNA immunotherapy clearing HPV-driven cervical pre-cancer, anoff-the-shelf cancer vaccine extending remission in ovarian cancer, an engineered IL-2 antibody pulling responses out of melanoma that had resisted every checkpoint inhibitor, and a topical hair-loss drug that may finally give men a side-effect-light alternative to finasteride. In Part 2 we cover:6. Bicycle Therapeutics — Zelenectide Pevedotin (BT8009) for Advanced Bladder (Urothelial) Cancer (Phase 2/3)7. ApolloBio (with INOVIO) — VGX-3100 for HPV-16/18 High-Grade Cervical Pre-Cancer (Phase 3)8. OSE Immunotherapeutics — Tedopi for Platinum-Sensitive Recurrent Ovarian Cancer (Phase 2)9. Aulos Bioscience — Imneskibart (AU-007) for Checkpoint-Inhibitor-Refractory Metastatic Melanoma (Phase 2)10. Cosmo Pharmaceuticals — Clascoterone 5% Topical Solution for Male Androgenetic Alopecia (Phase 3) The Bicycle Therapeutics readout is a fascinating proof-of-concept. Instead of a giant antibody hauling chemo to a tumor, Bicycle uses a tiny constrained peptide as the targeting head — small enough to penetrate solid tumors more deeply and clear from the body faster than a traditional antibody-drugconjugate. Positive Phase 2 data in advanced bladder cancer suggest this 'bicycle' platform could become a new way to deliver targeted chemotherapy across many cancers. We also pull back to identify the big pipeline themes connecting all ten of this week's readouts. Catch Part 1 if you missed it. Subscribe at TrialBreaks.com (TrialBreaks.com) #biomedicine #clinicaltrials #science #oncology #bladdercancer #ovariancancer #melanoma #immunotherapy #HPV #cervicalcancer #dermatology #hairloss #vaccines#drugdiscovery #ADC

14. 

    26 May 2026

    Last Week in Biomedicine | May 18–22 | Part 1 of 2: Retatrutide Obesity, Sac-TMT Cancer Win

    This week the biggest story in clinical trial results came out of an obesity trial: Eli Lilly's retatrutide — a once-weekly shot that activates three different appetite-and-metabolism hormones (GIP, GLP-1, and glucagon) at the same time — helped adults with obesity lose an average of roughly 30% of their body weight at 80 weeks. That level of weight loss was previously only seen with bariatric surgery. We also unpack a TROP-2 antibody-drug conjugate from Merck and Kelun-Biotech thatscored back-to-back Phase 3 wins in two tough cancers, plus a novel approach to gout and a new mechanism for stubborn high blood pressure. In Part 1 we cover:1. Eli Lilly — Retatrutide for Obesity (Phase 3)2. Merck — Sacituzumab Tirumotecan (sac-TMT) for Advanced or Recurrent Endometrial Cancer (Phase 3)3. Kelun-Biotech — Sacituzumab Tirumotecan (sac-TMT) for First-Line Advanced Triple-Negative Breast Cancer (Phase 3) 4. Sobi — Pozdeutinurad for Gout (Phase 3)5. Mineralys Therapeutics — Lorundrostat for Uncontrolled and Resistant Hypertension, Including Patients With Chronic Kidney Disease (Phase 3) The retatrutide readout matters because obesity affects more than a billion people globally, and an injectable medicine reaching surgery-level weight loss could change how doctors and patients think about treatment — moving it from a'maybe later' option to a frontline tool. The same week's sac-TMT cancer wins point to a new class of 'guided-missile' chemotherapy that homes in on the TROP-2 protein found on many tumors, and the gout and hypertension readoutsboth crack open therapy classes that have been stuck for decades. Part 2 drops Thursday. Subscribe at TrialBreaks.com (TrialBreaks.com)#biomedicine #clinicaltrials #science #obesity #GLP1 #oncology #breastcancer #endometrialcancer #ADC #cardiology #hypertension #gout #immunotherapy #drugdiscovery

15. 

    21 May 2026

    Last Week in Biomedicine | May 11–15 | Part 2

    Top 10 significant clinical trial results from last week Part 2: 6. Enterprise Therapeutics (private) — ETD001 (inhaled ENaCblocker) for cystic fibrosis (Phase 2) 7. Daré Bioscience ($DARE) — Ovaprene (hormone-free monthly intravaginal contraceptive) for contraception (Phase 3) 8. Candel Therapeutics ($CADL) — aglatimagene besadenovec (CAN-2409) for localized prostate cancer (Phase 3) 9. Alpha Tau Medical ($DRTS) — Alpha DaRT intratumoral alpha-radiotherapy for recurrent glioblastoma (Phase 2) 10. IMUNON ($IMNN) — IMNN-001 (IL-12 plasmid gene therapy) for advanced ovarian cancer (Phase 2) Subscribe for weekly clinical trial breakdowns at TrialBreaks.com (TrialBreaks.com) #biotech #clinicaltrials #pharma #genetherapy #Duchenne #DMD #GLP1 #obesity #oncology #immunotherapy #headandneckcancer #pulmonology #IPF #cysticfibrosis#womenshealth #prostatecancer #glioblastoma #ovariancancer #sleepmedicine

16. 

    19 May 2026

    Last Week in Biomedicine | May 11–15 | Part 1

    Top 10 significant clinical trial results from last week Part 1: 1. REGENXBIO ($RGNX) — RGX-202 microdystrophin gene therapy for Duchenne muscular dystrophy (Phase 3) 2. Alkermes ($ALKS) — LUMRYZ (sodium oxybate once-nightly) for idiopathic hypersomnia (Phase 3) 3. Viking Therapeutics ($VKTX) — oral VK2735 (GLP-1/GIP dual agonist) for obesity (Phase 2) 4. Inhibrx Biosciences ($INBX) — INBRX-106 (hexavalent OX40 agonist) plus pembrolizumab for first-line PD-L1+ head and neck squamous cell carcinoma (Phase 2) 5. United Therapeutics ($UTHR) — Tyvaso (inhaled treprostinil) for idiopathic pulmonary fibrosis (Phase 3) Subscribe for weekly clinical trial breakdowns at TrialBreaks.com (TrialBreaks.com) #biotech #clinicaltrials #pharma #genetherapy #Duchenne #DMD #GLP1 #obesity #oncology #immunotherapy #headandneckcancer #pulmonology #IPF #cysticfibrosis#womenshealth #prostatecancer #glioblastoma #ovariancancer #sleepmedicine

17. 

    12 May 2026

    Last Week in Biomedicine | May 4-9

    Last week's biggest biotech story: Cytokinetics hit both dual primary endpoints in the ACACIA-HCM pivotal Phase 3 trial of aficamten in non-obstructive hypertrophic cardiomyopathy — the first cardiac myosin inhibitor to win in nHCM and a major franchise expansion. Moderna's mRNA-1010 flu vaccine also landed in NEJM, and DDW 2026 drove a cluster of IBD readouts. This week we cover: 1. Cytokinetics ($CYTK) — aficamten for non-obstructive hypertrophic cardiomyopathy (Phase 3) 2. Moderna ($MRNA) — mRNA-1010 seasonal influenza vaccine (Phase 3) 3. Avalo Therapeutics ($AVTX) — abdakibart (AVTX-009) for hidradenitis suppurativa (Phase 2) 4. Viridian Therapeutics ($VRDN) — elegrobart for chronic thyroid eye disease (Phase 3) 5. Johnson & Johnson ($JNJ) — JNJ-4804 (guselkumab + golimumab) for refractory ulcerative colitis and Crohn's disease (Phase 2b) 6. Bayer ($BAYRY) — asundexian for secondary stroke prevention (Phase 3 OCEANIC-STROKE late-breaking) 7. AbbVie ($ABBV) — risankizumab (Skyrizi) and upadacitinib (Rinvoq) long-term IBD data (Phase 3) 8. Eli Lilly ($LLY) — mirikizumab (Omvoh) long-term IBD data (Phase 3) 9. Nuance Pharma (private) — nafithromycin (MIQNAF) for community-acquired bacterial pneumonia (Phase 3) 10. Bioxodes (private) — BIOX-101 for intracerebral hemorrhage (Phase 2a) The Cytokinetics nHCM win opens up a second indication for aficamten and pressures BMS's Camzyos directly, while Moderna's NEJM publication strengthens its bid for FDA approval and a seasonal flu commercial launch. DDW 2026 was a watershed for combination biologic IBD therapy. Subscribe for weekly clinical trial breakdowns at TrialBreaks.com #biotech #clinicaltrials #pharma #cardiology #HCM #obesity #vaccines #mRNA #immunology #IBD #ulcerativecolitis #Crohns #neurology #stroke #dermatology #hidradenitis #thyroideyedisease #infectiousdisease

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