Lexicon Pharmaceuticals to Present at the 4th Annual H.C. Wainwright BioConnect Investor Conference
Lexicon Pharmaceuticals (NASDAQ: LXRX) announced that its management will join a fireside chat at the 4th Annual H.C. Wainwright BioConnect Investor Conference on May 19, 2026, held at Nasdaq World Headquarters in New York. The session will be streamed live and archived on the company’s investor site. Lexicon highlighted its diversified pipeline spanning neuropathic pain, hypertrophic cardiomyopathy, obesity, and other cardiometabolic diseases. The appearance aims to update investors on development progress and strategic outlook.
FDA Approves First AI Test to Guide Breast Cancer Chemotherapy Decisions
The U.S. Food and Drug Administration has cleared ArteraAI Breast, the first artificial‑intelligence test designed to guide chemotherapy decisions for early‑stage, hormone‑receptor‑positive, HER2‑negative breast cancer. The digital‑pathology platform scans resection slides, combines them with clinical variables, and uses a multimodal...
Novo Says High-Dose Wegovy Can Cause 28% Weight Loss
Novo Nordisk reported that its high‑dose 7.2 mg Wegovy formulation enabled early responders to lose nearly 28 % of body weight in the 72‑week STEP UP trial. Across the 1,400‑patient study, average weight loss reached 21 %, with 27 % of participants qualifying as early...
BridgeBio’s Attruby Challenges Pfizer’s Vyndamax Legacy in Pivotal ATTR Trial
BridgeBio unveiled pivotal Phase III ATTRibute‑CM data for its FDA‑approved drug Attruby at the ESC 2026 Heart Failure congress. The study showed sustained wild‑type transthyretin levels, a 40% drop in outpatient worsening heart‑failure events, and a 34% reduction in cardiovascular hospitalisations...
Researchers Develop Innovative Model for Risk Assessment for Hypertrophic Cardiomyopathy
A NIH‑funded international study of 2,700 hypertrophic cardiomyopathy (HCM) patients introduced a new risk‑assessment model that combines clinical history, contrast‑enhanced cardiac MRI, and NT‑proBNP blood biomarker data. Over a seven‑year follow‑up, the model more accurately predicted sudden cardiac death, heart‑failure...
Novo Nordisk Reports New STEP UP Trial Analyses on Wegovy 7.2mg for Weight Loss
Novo Nordisk presented new sub‑analyses from the STEP UP trial comparing its higher‑dose Wegovy 7.2 mg weekly injection with the approved 2.4 mg dose and placebo in over 1,400 obese adults without diabetes. Over 72 weeks, the 7.2 mg regimen produced an average 20.7%...
Contributor: Fuel Drug Development, Not Big Pharma's Profits
The author, a 65‑year‑old ALS patient, urges faster U.S. drug development for amyotrophic lateral sclerosis, highlighting the pending ACT for ALS legislation. He notes more than 200 ALS drug candidates are stalled by a system that favors large pharmaceutical firms...
US Government Studies Into Vaccine Safety Are Being Suppressed | Robert B Shpiner
The FDA withdrew two peer‑reviewed COVID‑19 vaccine safety studies—one analyzing 7.5 million Medicare beneficiaries and another covering 4.2 million recipients—after political appointees refused to sign off, despite journal acceptance. A separate Shingrix safety abstract was also blocked, even though it confirmed a...
AI-Designed Drug Reduces Fentanyl Consumption in Animal Models by Targeting Serotonin Receptors
Researchers at UC Irvine used an artificial‑intelligence platform to design a novel serotonin‑receptor drug, GATC‑1021, that dramatically lowers fentanyl self‑administration in rats. In dose‑response studies the compound cut fentanyl intake by more than 60% and maintained efficacy without developing tolerance....
FDA Approves Early Warning System for Sepsis
U.S. Food and Drug Administration has cleared the Targeted Real‑Time Early Warning System, an AI‑driven tool from Johns Hopkins and Bayesian Health that flags sepsis before clinicians suspect it. The system can detect the infection 2 to 48 hours earlier...
How an ‘Impossible’ Idea Led to a Pancreatic Cancer Breakthrough
Daraxonrasib, a KRAS‑targeting drug, is on the brink of regulatory approval and has shown the first meaningful survival benefit for pancreatic cancer patients. The molecule binds a mutated KRAS protein long deemed “undruggable,” a breakthrough that also appears effective against...
Inhibrx Announces Positive Interim Results From HexAgon Trial
Inhibrx Biosciences reported positive interim Phase II data from its HexAgon trial of INBRX‑106 combined with pembrolizumab in PD‑L1‑positive metastatic head and neck squamous cell carcinoma. In the evaluable cohort, the combination achieved a 44% objective response rate versus 21% with...
EktaH Links Novel Obesity Drug to Fat Loss, Muscle Retention in Early-Phase Trial
EktaH disclosed early‑phase data for two oral candidates that activate fat‑taste receptors CD36 and GPR120, aiming to treat obesity by restoring lipid sensing. In a four‑week dose escalation study, the CD36/GPR120 agonist NKS‑5 reduced fat mass by 4.30% and modestly...
Ultrasound-Activated Nanoparticles Shine a Light Deep Within Living Tissues
Stanford researchers have demonstrated that ultrasound can activate mechanoluminescent nanoparticles to emit blue light deep within living tissue. By coating Sr4Al14O25:Eu,Dy particles with a biocompatible film and injecting them into mice, they produced programmable 490 nm illumination in organs such as...
The Real Reason CGT Programs Struggle to Scale
Cell and gene therapy (CGT) programs often start with fresh leukapheresis material because it speeds early feasibility work. As patient cohorts and sites expand, the tight timing and manual handling of fresh workflows create operational variability and strain manufacturing capacity....
Nicotinamide Nanotubes Restore Brain Cell Energy After Acute Injury
Researchers reported that nicotinamide‑loaded peptoid nanotubes (NAM‑PNTs) restore cellular energy in acute neonatal brain injury models. The nanostructures deliver an NAD⁺ precursor directly to microglia, boosting ATP, reducing inflammatory cytokines, and improving tissue histology after a single systemic dose. Efficacy...
Digital Aging Twin Measures How Organs Age at Different Speeds Across Adulthood
Researchers from China’s Aging Biomarker Consortium unveiled the Digital Aging Twin, a computational framework that predicts biological age and organ‑specific aging rates using 240 physiological and multi‑omics measures from 2,019 healthy adults. The system features a three‑tier clock architecture, with...
Stable Producer Cell Line Generation Platform Adds to VIVEbiotech’s Lentiviral Vector Manufacturing Capabilities
VIVEbiotech has introduced EvoLVcell, a stable producer cell line (SCL) generation platform that integrates a developer’s transgenic element into a fully characterized monoclonal lentiviral packaging cell line, eliminating the need for transfection. The solution reduces batch‑to‑batch variability, lowers impurity levels,...
Postbiotics Use Reduces Gingival Inflammation - Japan Study
A double‑blind, placebo‑controlled trial in Japan found that a gummy containing 500 mg of heat‑inactivated Lactiplantibacillus pentosus ONRICb0240 significantly reduced gingival inflammation over six weeks. Participants taking the postbiotic showed bleeding on probing fall from 17.6% to 12.3% and a Gingival...
RNA Therapy Slows Harmful Heart Remodeling After Heart Attack in Clinical Trial
A Phase II international trial (HF‑REVERT) tested CDR132L, an antisense inhibitor of microRNA‑132, in 294 patients who suffered a heart attack. The drug was administered in three intravenous doses alongside standard heart‑failure therapy and proved safe, with no liver, kidney or...
H.C. Wainwright Is Bullish on Relay Therapeutics, Inc. (RLAY)
H.C. Wainwright raised Relay Therapeutics' (RLAY) price target to $25 and kept a Buy rating, citing Phase 1 data that de‑risk the upcoming Phase 3 trial. The FDA granted Breakthrough Therapy designation for the zovegalisib‑fulvestrant combo targeting PIK3CA‑mutant HR+/HER2‑negative advanced breast cancer,...
Is Biogen Inc. (BIIB) One of the Best Biotech Stocks to Invest In According to Billionaire Steve Cohen?
Biogen Inc. agreed to pay up to $850 million for exclusive Greater China rights to felzartamab, an experimental immune‑therapy from TJ Biopharma. The deal includes a $100 million upfront payment and up to $750 million in milestones and royalties. Felzartamab is in late‑stage...
Is Regeneron Pharmaceuticals (REGN) Among the Best Biotech Stocks to Invest In According to Billionaire Steve Cohen?
Regeneron Pharmaceuticals received FDA approval for Otarmeni, the first gene therapy targeting genetic hearing loss caused by OTOF gene mutations. The treatment delivers a functional copy of the OTOF gene via a viral vector directly into the cochlea and will...
AstraZeneca PLC (AZN) Stock Falls as FDA Panel Votes Against New Cancer Drug
AstraZeneca’s oral breast‑cancer candidate camizestrant faced a setback when an FDA advisory panel voted 6‑3 against its approval on May 1. The panel cited the SERENA‑6 trial’s inability to demonstrate a long‑term survival advantage for early switching, though it raised no...
Immunome, Inc. (IMNM) Reports Submission of an NDA for Varegacestat in Desmoid Tumors
Immunome, Inc. filed a new drug application with the FDA for varegacestat, a gamma‑secretase inhibitor aimed at treating desmoid tumors. The filing relies on Phase 3 RINGSIDE trial data that met its primary endpoint, showing an 84% reduction in the risk...
Wedbush Maintained an Underperform Rating on Praxis Precision Medicines, Inc. (PRAX)
Wedbush lifted Praxis Precision Medicines' (PRAX) price target from $130 to $166 but left its rating at Underperform, citing concerns over the ulixacaltamide filing and valuation. The FDA has accepted NDAs for ulixacaltamide and relutrigine, setting PDUFA decision dates for...
Merck (MRK) Tops Quarterly Sales Forecasts as Keytruda Drives Growth
Merck reported first‑quarter 2024 revenue of $16.3 billion, a 5% increase that topped analysts’ $15.8 billion estimate. Keytruda drove the beat, posting $8 billion in sales, up 12% and above the $7.6 billion consensus, lifting the stock 5% in pre‑market trading. A $3.62‑per‑share charge...
Arvinas Inc (ARVN) Q1 2026 Earnings Call Transcript
Arvinas reported a steep revenue drop to $9.5 million in Q4, primarily due to the loss of a $40 million Novartis license, while cash fell to just over $85 million. The company cut G&A and R&D expenses, extending its cash runway into 2028,...
Imunon Inc (IMNN) Q1 2026 Earnings Call Transcript
Imunon reported $5.3 million cash on hand, extending its runway to mid‑Q1 2026 after a $4.5 million equity raise. Operating expenses fell 31% YoY, with R&D down 44% and CMC down 52%, cutting monthly burn to $1.25‑$1.5 million. The pivotal OVATION 3 phase III ovarian‑cancer trial...
Legend Biotech Corp (LEGN) Q1 2026 Earnings Call Transcript
Legend Biotech reported a blockbuster Q1 2026, with CARVYKTI net trade sales reaching $555 million—a 66% year‑over‑year increase—and total revenue climbing 64% to $306 million. Gross margins held steady at 61% while operating loss shrank 75% to roughly $20 million, delivering a modest...
Acurx Pharmaceuticals Inc (ACXP) Q1 2026 Earnings Call Transcript
AcelRx announced that its sufentanil product DSUVIA received Milestone C approval from the Department of Defense, allowing inclusion in U.S. Army kits. The company forecasts roughly $30 million in initial military orders over the next three years and expects broader adoption...
Reconnecting Body and Brain: Europe's Breakthrough in Reversing Paralysis
European researchers have unveiled a fully implantable brain‑spine interface that bridges damaged neural pathways, allowing paralysis patients to move voluntarily. The EU‑funded ReverseParalysis project demonstrated the technology in four patients, with two regaining the ability to stand and walk and...
Testosterone Treatment Found to Improve Sexual and Physical Function for Men After Prostate Cancer Surgery
A randomized SPIRIT trial led by Shalender Bhasin showed that three months of testosterone replacement therapy (TRT) markedly improved sexual activity, desire, physical function, and aerobic performance in men who had undergone radical prostatectomy. The study enrolled 136 men with...
The BioPharm Brief: Precision Medicine Expansion Accelerates Autoimmune and Targeted Oncology Development
The FDA broadened Vyvgart’s label to cover all adult patients with generalized myasthenia gravis, removing the previous antibody‑status restriction. Zai Lab received fast‑track designation for its DLL3‑targeting antibody‑drug conjugate aimed at extrapulmonary neuroendocrine carcinomas, a disease with limited options. The...
FDA Seeks Input On Chronic Diseases To Prioritize For Drug Repurposing
The FDA announced a public‑comment period to identify chronic diseases that should be prioritized for drug‑repurposing. The agency seeks stakeholder input on which conditions lack commercial interest and which approved drugs could be redirected to new therapeutic uses. This effort...
FDA Clears High-Pressure Balloon Catheter for BAV Procedures
Corvention, an Arizona‑based medtech startup, received FDA clearance for its KardiaPSI high‑pressure balloon catheter used in balloon aortic valvuloplasty (BAV). The device is engineered to retain its diameter under extreme pressures, delivering precise focal force in heavily calcified aortic valves....
New Coronary IVL Tech From Boston Scientific Impresses in First-in-Human Study
Boston Scientific’s Seismiq 4CE Coronary IVL Catheter, a laser‑driven intravascular lithotripsy system, completed a first‑in‑human study of 41 patients with severely calcified coronary lesions. The device achieved a 97.4% device‑success rate and a 90.2% freedom‑from‑major‑adverse‑cardiovascular‑events at 30 days, with procedural success...
How Tissue-Based Approaches Are Enabling Long-Term Implants
A new class of medical devices that integrate directly with the body’s own tissue is emerging, promising longer functional lifespans and fewer replacement surgeries. John Schorgl, CEO of Peytant Solutions, explains how tissue‑based designs improve implant stability, promote natural healing,...
Subcutaneous Furosemide Aids With Earlier Discharge: SUBCUT II HF
A randomized SUBCUT II HF trial in 22 UK hospitals showed that subcutaneous furosemide delivered via a minipump enables safe early discharge for heart‑failure patients. The early‑discharge arm reduced average hospital stay from 11.0 to 5.6 days and added four additional days...
BIOTECanada Statement on Canada–Mexico Life Sciences Collaboration
BIOTECanada signed two memoranda of understanding with Mexico’s Asociación Mexicana de Laboratorios Farmacéuticos (AMILAF) and La Cámara Nacional de la Industria Farmacéutica (CANIFARMA), marking a new phase of life‑sciences collaboration. The MoUs were part of Mexico’s trade mission to Canada,...
A New Hantavirus Vaccine Is in the Works
Moderna announced that it is co‑developing an mRNA‑based hantavirus vaccine with Korea University’s Vaccine Innovation Center, a partnership that began in 2023. The effort follows a deadly outbreak on a Dutch cruise ship that killed three passengers and highlighted the...
FDA Alerts Health Care Providers and Patients About Increased Risk of New Blood Cancers with Tazverik (Tazemetostat) Use; Sponsor to...
The FDA has announced a voluntary market withdrawal of Tazverik (tazemetostat) after a Phase 1b/3 SYMPHONY‑1 trial revealed a 5.7% incidence of hematologic second primary malignancies (SPMs) in treated patients, compared with none in the control arm. The drug, approved in...
Advancing Aseptic Precision: How Modern Filling Lines Elevate Sterility, Flexibility, and Throughput
Modern pharmaceutical filling lines are adopting isolator‑based, fully automated systems that integrate washing, sterilization, filling, sealing, and environmental control. Automation and AI‑driven analytics are boosting sterility assurance, reducing human intervention, and meeting stricter EU GMP Annex 1 and FDA requirements. These...
Advancing Generic Drug Development: Bioequivalence Challenges for Patient-Centric Oral Formulations - 06/11/2026
The FDA’s Center for Drug Evaluation and Research hosted a two‑day workshop on June 11, 2026 to address bioequivalence challenges in patient‑centric oral generic drugs, including pediatric formulations. Experts discussed development hurdles for chewable tablets, orally disintegrating tablets, granules, suspensions, and sublingual...
Diuretic Resistance Score Confirms TRANSFORM-HF’s Message
A post‑hoc analysis of the TRANSFORM‑HF trial applied the BAN‑ADHF risk score to identify patients at high risk of diuretic resistance. About 21% of the 2,421 participants scored above 12, indicating a markedly worse prognosis with 79% higher mortality and...
In the Clinic for May 11, 2026
BioWorld’s May 11, 2026 “In the Clinic” roundup aggregates the day’s most relevant biopharma and med‑tech snapshots, special reports, and infographics. The page links to data‑driven analyses covering topics from mRNA vaccine research and China’s GLP‑1 landscape to pulsed‑field ablation for atrial...
An Ancient Hibernation Switch Lives in Your DNA—And Scientists Are Tapping Into Its Power
Scientists have identified ancient cis‑regulatory DNA switches that enable hibernating mammals to shut down and restart metabolism safely, and they found the same genetic circuitry embedded in the human genome. The finding comes from two new studies published in Science...
New Home for Novo's Parkinson's Cell Therapy; GSK's Deal to Sell Drug in China
Novo Nordisk has transferred its early‑stage Parkinson's disease cell therapy to a specialized biotech partner, allowing the pharma giant to offload development risk while retaining royalty rights. GSK secured a distribution agreement to launch its flagship drug in China, opening...
RegVelo AI Model Predicts Cell Fate, Tackles Developmental Disorders and Cancer
Researchers at the Stowers Institute unveiled RegVelo, an AI framework that fuses RNA‑velocity dynamics with gene‑regulatory network inference to map cell‑state transitions over time. In zebrafish neural‑crest development the model pinpointed tfec as an early pigment‑cell driver and discovered a...