Zentalis Pharmaceuticals to Present Phase 1b MUIR Trial Data Showing Encouraging Clinical Activity and Manageable Safety Profile of Azenosertib Plus...
Zentalis Pharmaceuticals will present Phase 1b MUIR trial results showing that the WEE1 inhibitor azenosertib combined with paclitaxel yields a 39% overall response rate and a median progression‑free survival of 7.3 months in heavily pre‑treated platinum‑resistant ovarian cancer (PROC) patients. The data, derived from 46 participants, include a 50% response rate in the 250 mg intermittent dose cohort, with a median duration of response of 9.2 months. Safety was manageable, with grade ≥ 3 neutropenia in 30% of patients and a single treatment‑related death. The findings will be presented at ASCO 2026, supporting broader development of azenosertib‑taxane combos.
#ASCO26: Key Head and Neck Cancer Readouts From J&J, Corbus, Summit, Akero and Bicara
At ASCO 2026, Johnson & Johnson, Corbus, Summit, Akero and Bicara unveiled pivotal data on next‑generation therapies for head and neck squamous cell carcinoma. J&J’s pembrolizumab‑plus‑chemotherapy regimen reduced the risk of death by roughly 20% in first‑line patients. Corbus reported...
#ASCO26: New Data Released for VEGF Bispecifics From BioNTech-BMS, Pfizer-3SBio
At ASCO 2026, BioNTech‑BMS and Pfizer‑3SBio unveiled new Phase 1/2 data on their VEGF‑targeting bispecific antibodies. BioNTech‑BMS reported a 45% overall response rate in heavily pre‑treated solid‑tumor patients, while Pfizer‑3SBio’s candidate achieved disease control in 78% of a similar cohort....
STAT+: Merck-Kelun Lung Cancer Drug Cut Risk of Tumor Progression by 65%, ASCO Abstract Shows
Merck and China‑based Kelun‑Biotech announced that their antibody‑drug conjugate sacituzumab tirumotecan (sac‑TMT) reduced the risk of tumor progression by 65% in a Phase 3 trial of untreated advanced non‑small cell lung cancer (NSCLC). The study, conducted in China, also showed an...
Hutchmed, Innovent Win Chinese Approval for Fruquintinib‑Sintilimab Combo in Kidney Cancer
Hutchmed (China) Limited and Innovent Biologics announced that China’s National Medical Products Administration has approved ELUNATE (fruquintinib) combined with TYVYT (sintilimab) for patients with locally advanced or metastatic renal cell carcinoma who have exhausted prior VEGFR‑TKI therapy. The decision follows...
AI‑Designed Protein Nanocages Reach 220 Nm, Paving Way for Next‑Gen Vaccines
Researchers from Pohang University of Science and Technology and the University of Washington announced AI‑guided creation of quasisymmetric protein nanocages ranging from 70 nm to 220 nm. Published in Nature, the work shows a single, computationally designed protein can self‑assemble into virus‑like...
Eli Lilly Buys Engage Bio for $202M, Adding Non‑Viral DNA Delivery Platform
Eli Lilly agreed to acquire Engage Bio for up to $202 million in cash, securing the startup’s preclinical non‑viral DNA delivery platform, Tethosome. The deal marks Lilly’s seventh acquisition of 2026 and deepens its push into genetic medicines beyond its blockbuster...
Cytokine‑Armored CAR T Cells Overcome Antigen Heterogeneity in Glioma Model
UCLA researchers have engineered cytokine‑armored CAR‑T cells that secrete IL‑12 and a decoy‑resistant form of IL‑18 (DR‑18) to treat glioblastoma in mouse models. The IL‑12/DR‑18 combination enabled CAR‑T cells to eradicate tumors even when cancer cells lacked the targeted IL‑13Rα2...
New Eye Drop Formulation Shows Promise for Dry Eye Disease
Researchers at Baylor College of Medicine and Okayama University have created a water‑soluble rexinoid eye‑drop, NEt‑3IB, that boosts resident macrophage function and mitigates dry‑eye pathology in mouse models. The formulation significantly lowered ocular inflammation, preserved corneal barrier integrity and goblet...
Vitamin B12 Analog Targets Deadly Brain Cancer Cells
Researchers at Nitric Oxide Services and Cleveland Clinic have demonstrated that nitrosylcobalamin, a nitric‑oxide‑releasing vitamin B12 analog, can penetrate the blood‑brain barrier and preferentially accumulate in glioblastoma tissue in rat models. Pharmacokinetic data show sustained tumor nitrate levels for at...
Site-Centered Startup: Approaching Predictability in an Imperfect System
Study start‑up continues to be hampered by complex protocols, lengthy negotiations, and fragmented communication. ICON’s executive vice president Brian Mallon argues that a site‑centered model—integrating early feasibility with real‑world capacity, sustained momentum, and automation—can transform activation from an imperfect science...
KHL Foundation Launches a Medical Tourism Gene Therapy Program for Older Patients
The KHL Foundation, founded by longevity veterans Ken Scott and Helga Sands, has launched a medical‑tourism program that offers a gene‑therapy cocktail to people over 60. The Rejuvenation Cocktail combines intramuscular follistatin with intranasal klotho and SIRT1, targeting muscle, brain...
LLY Clears Major Obesity Trial: Get Exposure in THNR
Eli Lilly’s latest obesity drug trial delivered an average weight loss of just under 30%, surpassing comparable GLP‑1 products from rivals such as Novo Nordisk. The strong results sparked a more than 3% rise in LLY’s stock over the past five days,...
Wacker Expands Service Offerings with Launch of Contract Research for Nucleic Acid-Based Therapies
Wacker Chemie has launched a contract research service (CRS) at its Munich biotech center, offering R&D‑grade plasmid DNA, RNA and lipid nanoparticle (LNP) production for preclinical studies. The offering adds construct design, lipid library screening, functional assays and analytical support,...
Massive Bio and BeeKeeperAI Deploy Federated Confidential Computing to Expand Oncology Trial Access Across Atlanta’s Underserved Communities
Massive Bio announced an expansion of oncology trial access in Atlanta’s underserved communities by deploying its AI‑powered patient pre‑screening on BeeKeeperAI’s EscrowAI platform. The collaboration uses federated confidential computing to run matching algorithms inside healthcare providers’ secure environments, keeping PHI...
Billion Cell Atlas: AI to Build ‘Most Comprehensive Map of Human Disease Biology’ Yet
Illumina announced the Billion Cell Atlas, a project to profile one billion cells with CRISPR perturbations across more than 200 disease‑relevant cell lines. The effort, backed by AstraZeneca, Merck and Eli Lilly, will generate roughly 20 petabytes of single‑cell RNA‑seq data in...
Wegovy Shows 22% Average Weight Loss and Cardiovascular Gains for Menopausal Women
Novo Nordisk announced that Wegovy (semaglutide) produced an average 22.6% weight loss in premenopausal women and roughly 20% loss in perimenopausal and postmenopausal groups, while also cutting heart attack, stroke, migraine and depression risks. The findings were unveiled at the...
MaaT Pharma Requests EMA Re‑examination After CHMP Issues Negative Trend Opinion on Xervyteg
MaaT Pharma announced it will request a re‑examination of its marketing authorization for Xervyteg (MaaT013) after the EMA’s CHMP issued a negative trend opinion. The formal CHMP vote is slated for June 2026, and the company says it remains committed...
Canada and India Now Have Generic Wegovy. Here’s Why the U.S. Doesn’t.
Novo Nordisk’s GLP‑1 drugs Ozempic and Wegovy have entered the Canadian market as generics, and multiple Indian manufacturers have already launched lower‑priced versions. In India, generic prices are up to 80% below the brand‑name rates, and upcoming launches in Brazil,...
Regenxbio’s RGX-202 Gene Therapy Hits Primary Endpoint in Phase 3 Duchenne Trial
Regenxbio announced that its RGX-202 gene therapy met the primary endpoint in the Phase 3 portion of the AFFINITY DUCHENNE trial, with 93% of participants reaching at least 10% microdystrophin expression. The data support an accelerated FDA filing and set...
Applied Biopharm Consulting Partners with South East Technological University to Advance Viral Vector Research
Applied Biopharm Consulting has teamed with South East Technological University’s Pharmaceutical and Molecular Biotechnology Research Centre under Ireland’s Enterprise Ireland Innovation Voucher scheme to experimentally validate its AI‑driven viral vector engineering platform. The partnership will conduct cell‑based studies that generate...
Financings for May 21, 2026
BioWorld reported three major developments on May 21, 2026. Researchers unveiled a “detargeted” gene‑therapy platform that enhances enzyme activity and reduces off‑target effects for Pompe disease. The World Health Organization declared the Ebola outbreak in the Democratic Republic of Congo a public‑health...
Drug Application Process for Nonprescription Drugs
The FDA offers two routes—New Drug Application (NDA) and Abbreviated New Drug Application (ANDA)—to bring nonprescription drugs to market. Sponsors must secure approval before sales, and they can file directly for OTC status or transition a prescription product. Critical to...
First FDA‑approved Longevity Drug Targets Dogs First
NEW Exclusive Interview: This miracle pill could make dogs live longer, with Celine Halioua, Founder & CEO of Loyal @celinehalioua is building the first drug ever FDA-approved for lifespan extension itself — starting with dogs. We sat down on Onward to...
BioMarin Notches Win in Study that Could Expand Use of Top-Selling Medicine
BioMarin announced positive Phase 3 data showing its blockbuster drug Voxzogo accelerates growth in children with hypochondroplasia, a milder form of dwarfism. The trial reported significant gains in standing height and arm span after one year versus placebo. Analysts estimate the...
The Multiple Myeloma Revolution Happening Right Now: Swarup Kumar, MD
Swarup Kumar, MD highlights that bispecific antibodies are driving multiple myeloma cure rates up to 30‑40%, a stark rise from the historic sub‑10% figure. He notes that real‑world outcomes, while promising, still trail slightly behind trial data, underscoring the need...
Scribe Therapeutics Achieves Regulatory Clearance to Initiate First-in-Human Clinical Study of STX-1150 for LDL-C Reduction
Scribe Therapeutics received clearance from Australia’s TGA to start a first‑in‑human Phase 1 study of STX‑1150, an in‑vivo CRISPR‑based therapy that epigenetically silences PCSK9 to lower LDL‑C. The open‑label, single‑ascending‑dose trial will enroll up to 64 high‑risk hypercholesterolemia patients across Australia...
Merck Announces First Patient Dosed in Phase 3 Study for Investigational Antibody-Drug Conjugate in Colorectal Cancer
Merck has dosed the first patient in the Phase 3 PROCEADE‑CRC‑03 trial of Precem‑TcT, the company’s inaugural anti‑CEACAM5 antibody‑drug conjugate (ADC) featuring an exatecan payload for metastatic colorectal cancer (mCRC). In Phase 1, the ADC achieved a 20.7% confirmed objective response rate...
ASCO 2026: Bayer to Present New Data Across Oncology Portfolio
Bayer announced that it will unveil 16 new oncology abstracts at the ASCO 2026 meeting in Chicago, spanning prostate, breast, lung, renal‑cell, colorectal and salivary‑gland cancers. The headline presentation will feature Phase II head‑to‑head data comparing NUBEQA (darolutamide) with enzalutamide in...
AI‑Designed PE8 Editors Boost Prime Editing Efficiency
Today in @NatureBiotech we report a new suit of PE8 prime editor proteins. PE8 variants were developed from laboratory-evolved PE6 proteins using AI-guided protein redesign. This approach combines recent advances in computational protein design and directed evolution to increase prime...
Fixing Medication Adherence In Clinical Trials: How Technology Stops Data Corruption
Medication adherence in clinical trials is notoriously difficult to measure, with self‑reports often exceeding 90% while biomarker data reveal far lower rates. Traditional methods such as dosing diaries and pill counts are vulnerable to patient error and intentional manipulation, compromising...
Avaí Bio, Austrianova Advance Α-Klotho Cell Therapy Manufacturing Step
Avaí Bio and Austrianova have finished a GMP‑compliant master cell bank (MCB) of genetically engineered cells that overexpress the anti‑aging protein α‑Klotho. The bank will now undergo independent viral and adventitious‑agent testing before a working cell bank is created for...
ImmunityBio’s ANKTIVA + BCG Gets FDA Supplemental BLA Acceptance, Decision Set for Jan 6 2027
ImmunityBio announced that the FDA has accepted its supplemental biologics license application to expand ANKTIVA + BCG into BCG‑unresponsive non‑muscle invasive bladder cancer with papillary disease only. The agency set a PDUFA target action date of Jan. 6 2027, and the filing is backed...
How Eli Lilly's Next-Gen Obesity Drug Is 'Raising The Bar' In Weight Loss
Eli Lilly’s next‑generation obesity drug retatrutide delivered dramatic weight loss in the Phase 2 Triumph‑1 trial, with participants shedding an average 28.3% of body weight (about 70 lb) after 80 weeks and up to 30.3% (≈85 lb) in a 104‑week extension. Nearly half of...
Bayer Secures FDA Priority Review for Kerendia in Type 1 Diabetes‑Related Kidney Disease
Bayer AG announced that the U.S. FDA has granted priority review to its supplemental New Drug Application for Kerendia in adults with type 1 diabetes and chronic kidney disease. The decision follows positive Phase III FINE‑ONE data showing a significant reduction in...
M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)
The ICH has issued the M11 Template — Clinical Electronic Structured Harmonised Protocol (CeSHarP) – a draft guidance released in June 2025. The template standardizes the format, table of contents, and common headers for clinical trial protocols, while the accompanying Technical Specification defines...
Economic and Market Impact of the PRRS-Resistant Pig
In April 2025 the FDA cleared Pig Improvement Company’s gene‑edited PRRS‑resistant pig, a breakthrough against the disease that costs the global pork sector billions annually. Dr. Jayson Lusk of Oklahoma State University built an economic model to simulate adoption scenarios across...
Eli Lilly Reports P-III (TRIUMPH-1) Trial Data on Retatrutide for Weight Management
Eli Lilly’s phase‑III TRIUMPH‑1 trial showed its triple‑agonist retatrutide produced dramatic weight loss in adults with obesity and at least one weight‑related comorbidity. Across 80‑week endpoints, the 12 mg dose cut mean body weight by 28.3% and waist circumference by 24.1 cm, with...
Fixed-Duration AV Is a Compelling Option, With Important Caveats: Adam Kittai, MD
In a follow‑up interview, Dr. Adam Kittai of NYU Langone compares fixed‑duration acalabrutinib + venetoclax (AV) with continuous Bruton tyrosine kinase (BTK) inhibitor therapy for chronic lymphocytic leukemia (CLL). The AMPLIFY trial showed AV’s safety advantage—atrial fibrillation in 0.7% and major hemorrhage...
Retatrutide Delivers up to 30% Weight Loss in Phase 3 Trials
Retatrutide just delivered some very impressive phase3 results for $LLY at 4mg, 9mg and 12mg -- https://t.co/7sKbaDoInq Retatrutide is their GLP-3 ie triple agonist which hits the GLP, GIP and Glucagon receptors. At the primary endpoint of 80 weeks... patients on 4mg,...
IMMX Secures $150M at $8.94 to Fund NXC-201
$IMMX prices $150M underwritten offering at $8.94/share, with proceeds expected to fund continued NXC-201 development and extend operational runway into mid-2028. Morgan Stanley and BofA Securities are leading the deal. Read more: https://t.co/QxQsiNNXbz
Infex Chases After Insmed with Bronchiectasis Trial Win
Infex Therapeutics announced that its anti‑PcrV antibody RESP‑X (INFEX702) successfully completed a Phase 2a trial in patients with non‑cystic fibrosis bronchiectasis (NCFB) colonised by Pseudomonas aeruginosa. The study demonstrated early efficacy signals, a favorable safety profile and a 28.8‑day half‑life supporting...
Retatrutide Delivers Record 28% Weight Loss, Raises Safety Concerns
Retatrutide, a triple receptor drug for GLP-1, GIP, and glucagon, is the most powerful weight loss drug yet. A significant issue is too much weight loss among the trial participants. New randomized trial results announced today with 28% body weight...
Intellia Files First CRISPR‑Based BLA, Testing FDA’s New Post‑Approval Guidance
Intellia Therapeutics has filed a biologics license application for its in‑vivo CRISPR therapy targeting transthyretin amyloidosis, becoming the first CRISPR‑based product to be reviewed under the FDA’s September 2024 draft guidance on post‑approval monitoring. The move pits the company against...
Secret World of Cellular Communication Visualized in 3D Thanks to New Nanoscopy Method
Australian National University researchers unveiled RO‑iSCAT, a label‑free nanoscopy method that captures living cells in three dimensions over days. By rotating illumination and stacking images, the technique amplifies weak light signals tenfold, revealing dynamic, thread‑like nanoscale bridges that mediate cell‑to‑cell...
How Ossium Health Is Building an Off-the-Shelf Bone Marrow Transplant Model
Ossium Health is developing an off‑the‑shelf bone‑marrow product sourced from deceased organ donors, aiming to eliminate the timing and dose constraints of traditional live‑donor transplants. The company’s first‑in‑human PRESERVE I trial has treated about 25 patients with cryopreserved marrow and...
AIM ImmunoTech Secures $2.4 Million via Direct Share Offering and Warrant Placement
AIM ImmunoTech Inc. entered definitive agreements for a registered direct offering of 7.51 million shares at $0.325 per share, targeting roughly $2.4 million in gross proceeds. A concurrent private placement of Series I warrants for up to 15.04 million shares will also raise capital,...
What Does the Regulatory Landscape Look Like From the Other Side of FDA?
Harpreet Singh, MD, former FDA Oncology Division Director and now chief medical officer at Precision for Medicine, explains that industry sponsors find the oncology regulatory landscape more navigable when they leverage insider experience. He stresses three pillars: early and frequent...
Looking for a Lifeline: New Compounds Show Promise Against AMR
Scientists at Umeå University have created a new class of synthetic tricyclic compounds, called TriPcides, that effectively kill MRSA strains resistant to earlier GmPcide antibiotics. By redesigning the molecular scaffold to evade the lmrB efflux pump, the compounds prevent the...
Bayer Gets Swift Review for Kerendia in Type 1 Diabetes
Bayer has applied to the FDA for a label extension of its mineralocorticoid receptor antagonist Kerendia to treat chronic kidney disease in type 1 diabetes patients. The agency granted priority review, promising a decision within six months. Phase 3 FINE‑ONE data showed...