Generate Biomedicines’ IPO Brings In $400M for Pivotal Tests of Severe Asthma Drug
Generate Biomedicines priced its IPO at $16 per share, raising $400 million to fund pivotal trials of its lead candidate GB‑0895. The antibody blocks the TSLP pathway and is engineered for six‑month dosing, a potential advantage over existing asthma biologics that require more frequent injections. Two Phase 3 studies will evaluate annualized exacerbation rates in severe asthma patients, with readouts expected by late 2028. The company also plans to expand GB‑0895 into COPD and advance AI‑derived cancer programs.
Computer Run on Human Brain Cells Learned to Play ‘Doom’
Cortical Labs in Australia has upgraded its biocomputer, built from lab‑grown human neurons, to play the first‑person shooter *Doom*. The new CL1 platform translates visual game data into electrical stimulation patterns that the neuronal network can interpret, achieving adaptive, real‑time...
BioAtla Axes 70% of Staff, Explores Strategic Options
BioAtla announced it is slashing roughly 70% of its staff as it evaluates strategic alternatives, leaving only essential personnel for the review. The move follows a 30% reduction last year and leaves the company with about $7.1 million in cash, down...
Simulations of Your Gut May Predict Which Probiotics Will Stick
Researchers have built microbial community‑scale metabolic models that simulate how specific probiotic strains behave in an individual’s gut. Using baseline microbiome data, the models predicted engraftment with 75‑80% accuracy and linked bacterial growth to health outcomes such as improved post‑meal...
CollPlant Targets Formulation Bottleneck with New DLP Bioprinting Kit
CollPlant has introduced BioFlex, a ready‑to‑print DLP bioprinting kit built on recombinant human collagen and a biodegradable polymer. The kit includes pre‑validated photo‑active agents and detailed formulation guidelines, aiming to cut bioink development time for tissue‑modeling and organ engineering. By...
Alnylam Canada ULC – Receives Positive Recommendation From Canada’s Drug Agency (CDA) for the Public Reimbursement of AMVUTTRA® (Vutrisiran Injection),...
Alnylam Canada received a positive recommendation from Canada’s Drug Agency to list AMVUTTRA® (vutrisiran) for public reimbursement in adult patients with cardiomyopathy caused by wild‑type or hereditary ATTR amyloidosis. The therapy, approved by Health Canada in December 2025, expands the...
Moderna’s Dual Covid-Flu Vaccine Poised for EMA Approval on Positive CHMP Take
The European Medicines Agency’s CHMP has issued a positive opinion on Moderna’s mCombriax, a combined COVID‑19 and influenza mRNA vaccine, after a Phase III trial showed stronger immune responses than a mixed regimen of Sanofi’s flu shot and Spikevax. EMA approval...
Other News to Note for March 2, 2026
At CROI 2026, researchers spotlighted the growing neurodegenerative burden among aging people living with HIV, emphasizing heightened risks of depression and cognitive vulnerability despite long‑term antiretroviral therapy. Parallelly, the University of Southern California announced a novel series of MAPT aggregation...
In the Clinic for March 2, 2026
BioWorld’s “In the Clinic for March 2, 2026” page functions as a centralized gateway to the latest biopharma, med‑tech, and scientific content. It aggregates data snapshots, special reports, infographics, and market scorecards covering everything from GLP‑1 trends in China to mRNA vaccine...
Regulatory Actions for March 2, 2026
On March 2, 2026 BioWorld published a regulatory snapshot covering biopharma and med‑tech firms such as AS Software, Asieris, Boehringer Ingelheim, Deephealth, Eli Lilly, Ipsen, Moderna, Neurogene, Novartis, Optellum, Photocure, Regeneron, Sanofi, Sentynl, Synergy Spine Solutions and X4. The roundup highlights...
Newfound Third Cell Type Enables Fully Functional Hair Follicles in the Lab
Researchers identified a previously unknown accessory mesenchymal cell (PDGFRα⁺/Sca1⁺/CD34⁺) that enables complete hair follicle formation in a dish. By integrating this cell type with epithelial stem cells and dermal papilla cells, they created a three‑cell organ germ that grew downward,...
Ribosomes in Pairs: A Survival Strategy Inside Stressed Cells
Scientists at the Max Planck Institute have identified a novel RNA‑driven mechanism that pairs inactive ribosomes into disomes when animal cells, including neurons, face nutrient starvation or temperature stress. The pairing is mediated by a specific ribosomal RNA expansion segment,...
Researchers Create World's Largest Dog and Cat Tumor Database
Researchers from the University of Liverpool and the University of Las Palmas de Gran Canaria have launched the world’s largest open‑source tumor database for dogs and cats, containing over one million records. The registry covers more than 200 breeds and...
Bioxytran Reports Positive Phase 1b/2a Results for Antiviral ProLectin‑M
Bioxytran announced positive phase 1b/2a data for its oral antiviral ProLectin‑M in a randomized, double‑blind, placebo‑controlled trial of 39 mild‑to‑moderate COVID‑19 patients in India. The highest dose (16,800 mg/day) achieved viral clearance in 90% of participants by day 5 versus 20% on placebo,...
Vueway Expands Pediatric Use: Alberto Spinazzi Shares Bracco Group’s Vision
The European Union has granted approval for Vueway (gadopiclenol) to be used in neonates, infants, and toddlers, marking a pivotal expansion of pediatric MRI contrast agents. Vueway delivers diagnostic‑grade imaging at half the dose of conventional macrocyclic GBCAs, thanks to...
Safety Concerns Spur Aardvark to Halt Key Prader-Willi Drug Trial
Biotech Aardvark Therapeutics announced a voluntary pause of the Phase 3 HERO trial for its Prader‑Willi drug ARD‑101 after routine safety monitoring identified reversible cardiac observations in healthy volunteers receiving supratherapeutic doses. The pause affects both the main trial and an...
Merck, Pfizer’s Drug Combo ‘Rewrites the Standard of Care’ in Bladder Cancer
Merck and Pfizer’s Keytruda‑Padcev doublet delivered a dramatic survival advantage in the Phase 3 EV‑304 study of muscle‑invasive bladder cancer. The regimen cut the risk of disease progression, recurrence or death by 47% compared with gemcitabine‑cisplatin and lowered overall‑mortality risk by...
Big Pharma’s Next Entrant Could Come From China
Chinese drugmakers, led by Jiangsu Hengrui Pharmaceuticals, are emerging as global biotech contenders. Hengrui topped 2024 trial sponsorship, boasts a pipeline of 100 investigational drugs and 400 trials, and secured a $500 million partnership with GSK that could yield $12 billion. Analysts...
Nuclear Medicine Firm Shine Technologies Raises $240M
Shine Technologies announced a $240 million financing round led by Patrick Soon‑Shiong’s NantWorks, bringing its total capital raised to over $1 billion. The infusion will accelerate the company’s commercial fusion initiatives and expand its Lu‑177 isotope production, a cornerstone of targeted cancer...
Clinical Labs Gain Ground with Noninvasive Dd-cfDNA Transplant Surveillance
A new donor‑derived cell‑free DNA (dd‑cfDNA) blood test is transforming post‑transplant surveillance by providing real‑time, noninvasive insight into graft health. The assay quantifies donor DNA fragments released when a transplanted organ is injured, offering a high negative predictive value that...
Ascendis’ Yuviwel (Navepegritide) Receives the US FDA Accelerated Approval for Achondroplasia
The U.S. FDA granted accelerated approval to Ascendis’ Yuviwel (navepegritide) for increasing linear growth in children aged two years and older with achondroplasia and open epiphyses. Approval rests on three placebo‑controlled trials and up to three years of open‑label extension...
Why It’s Critical to Close Open Steps in Cell Therapy Manufacturing
Cell therapy manufacturing is vulnerable to contamination because living cells cannot be terminally sterilized. Regulatory bodies such as EU GMP Annex 1 and the FDA now require risk‑based contamination control strategies that prioritize closed, sterile, and automated processes. Closing open steps...
Sanofi Receives CHMP Recommendation for Dupixent Expansion in Europe
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending Dupixent (dupilumab) for paediatric chronic spontaneous urticaria (CSU) in children aged 2‑11. The recommendation is based on robust Phase III data from the LIBERTY‑CUPID...
Opus Genetics Reports Phase I/II Trial Results of OPGx-BEST1 Gene Therapy
Opus Genetics presented early Phase I/II data for its OPGx‑BEST1 gene therapy targeting best vitelliform macular dystrophy and autosomal‑recessive bestrophinopathy. In a sentinel 63‑year‑old participant, the treatment was well tolerated and delivered a 12‑letter gain in best‑corrected visual acuity after...
BioMarin Receives FDA Approval for Palynziq Use in Adolescents
BioMarin’s enzyme substitution therapy Palynziq received FDA approval for use in adolescents aged 12 and older with phenylketonuria (PKU). The decision was based on Phase III PEGASUS trial results showing 44.4% of participants lowered blood phenylalanine below guideline levels, with a...
18 UK Biotech Companies You Should Know About
The article profiles 18 UK biotech firms spanning oncology, immunology, regenerative medicine and AI‑driven drug design, highlighting recent milestones such as Amphista’s $30 million upfront deal with BMS, Autolus’ FDA and EU approvals for obe‑cel, and Isomorphic Labs’ $600 million raise to...
Monolithic 3D Nanoelectrode Arrays on CMOS Circuitry for Scalable, High‐Resolution Neural Recording
Researchers have developed a monolithic 3D nanoelectrode array (HD‑NEA) that integrates 26,400 vertical nanowire electrodes directly onto commercial CMOS chips. The low‑temperature wafer‑scale post‑fabrication process maintains circuit functionality while delivering uniform, high‑yield electrode performance across 4‑inch wafers. In vitro recordings...
X4 Pharmaceuticals’ Xolremdi (Mavorixafor) Receives the CHMP Positive Opinion for WHIM Syndrome
X4 Pharmaceuticals’ Xolremdi (mavorixafor) received a positive opinion from the European CHMP, recommending approval under exceptional circumstances with an EC decision expected in Q2 2026. The recommendation is based on the global Phase III 4WHIM trial involving 31 patients aged 12 and...
Ipsen Reports the CHMP Positive Opinion for Ojemda (Tovorafenib) for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG)
European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending conditional approval of Ipsen’s Ojemda (tovorafenib) as monotherapy for pediatric low‑grade glioma with BRAF fusions, rearrangements or V600 mutations. The recommendation is based on...
Defect Engineering of Bi2S3‐x@PDA/CuS Z‐Scheme Heterojunction for Enhanced Sonodynamic and Chemodynamic Cancer Therapy
Researchers have engineered a sulfur‑vacancy‑rich Bi2S3‑x@PDA/CuS (BPC) nanocomposite that forms a Z‑scheme heterojunction and is further functionalized with hyaluronic acid (BPC@HA). The defect‑rich structure enhances charge separation, enabling efficient singlet‑oxygen generation under ultrasound and Fenton‑like hydroxyl‑radical production for chemodynamic therapy....
FDA Action Alert: BMS, GSK, Aldeyra and More
The FDA will render decisions this March on five high‑profile drug applications, including two delayed from last year. Bristol Myers Squibb seeks a psoriatic arthritis label for Sotyktu, backed by Phase 3 data showing a 54.2% ACR20 response. Aldeyra, Rhythm, GSK...
Quanterix Corp (QTRX) Q4 2025 Earnings Call Transcript
Quanterix (QTRX) reported FY 2025 revenue of $16.1 million, down $11 million from the prior year, driven by steep declines in collaboration and contract‑manufacturing income. R&D spending fell modestly to $140.7 million, while SG&A rose to $65.5 million due to higher professional fees for...
Cerus Corp (CERS) Q4 2025 Earnings Call Transcript
Cerus Corp reported record total revenue of $233.8 million in 2025, a 16% increase year‑over‑year, driven by strong product sales and robust growth in EMEA. Product revenue rose 14% for both the quarter and full year, with IFC kit sales...
Combining Neurobiological Markers and a Sociodemographic Risk Score to Predict Adolescent Depression – An IDEA RiSCo Prospective Cohort Study
Researchers integrated inflammatory cytokines, kynurenine pathway balance, and amygdala reactivity with the IDEA‑RS sociodemographic risk score to predict adolescent depression over three years. The composite model (IDEA‑BIO‑RS) raised predictive accuracy from a 0.715 AUC to 0.889, correctly classifying 82.2% of...
Xeris Biopharma Holdings Inc (XERS) Q4 2025 Earnings Call Transcript
Xeris Biopharma reported record Q3 2025 product revenue of $74.1 million, a 40% year‑over‑year increase driven primarily by Recorlev’s 109% revenue jump. The company posted its first quarterly net income and an adjusted EBITDA of $17.4 million, reflecting strong operating leverage and...
Uniqure NV (QURE) Q4 2025 Earnings Call Transcript
UniQure reported a regulatory setback as the FDA now deems the Phase 1/2 external‑control data for AMT‑130 insufficient for a Biologics License Application, creating uncertainty around the U.S. filing timeline. Despite this, the high‑dose AMT‑130 achieved a statistically significant 75% slowdown...
Nuvation Bio Inc (NUVB) Q4 2025 Earnings Call Transcript
Nuvation Bio reported $7.7 million net product revenue for Iptrozi in Q3 2025, driven by 204 new patient starts and payer coverage expanding to over 80% of U.S. lives. Clinical data showed an 89% overall response rate and a median...
Rational Design of Rigid mRNA Folding Architecture to Enhance Intracellular Processing and Protein Production
A team of researchers from Singapore and China has engineered a rigid mRNA folding architecture that markedly improves intracellular processing and protein output. By integrating all‑atom and coarse‑grained molecular dynamics simulations with lipid‑nanoparticle (LNP) formulation, they created stiffened mRNA structures...
Drug Discovery Bottleneck? Cell-Free Platform Screens Peptides Faster, Even in Harsh Conditions
Researchers at the Innovation Center of NanoMedicine unveiled PL‑display, a cell‑free platform that immobilizes individual peptides on magnetic beads for rapid screening. The method delivers over ten‑fold efficiency gains versus traditional cell‑based displays and can operate under high‑temperature, high‑salt, or...
Why Crowning the Protein that Makes Jellyfish Glow Green as a Model Can Help Scientists Streamline Biology
The article proposes designating green fluorescent protein (GFP) as a model protein to standardize protein research, much like fruit flies or mice serve as model organisms. It argues that GFP’s visual read‑out makes it ideal for benchmarking AI‑generated protein designs...
Hidden Ingredient in Ozempic and Wegovy Tablets Raises New Gut Health Questions
Researchers at Adelaide University conducted the first in‑vivo study of salcaprozate sodium (SNAC), the absorption enhancer used in oral semaglutide tablets such as Ozempic and Wegovy. Over a 21‑day period in rats, repeated SNAC exposure reduced fibre‑degrading gut bacteria, lowered...
In China, Phase 2 Study of Relma-Cel in R/R MCL Finds Durable Responses
A phase‑2 trial of relmacabtagene autoleucel (relma‑cel), a CD19‑directed CAR‑T therapy, enrolled 59 Chinese patients with relapsed/refractory mantle‑cell lymphoma after BTK‑inhibitor failure. The study reported a 71.2% overall response rate and a 59.3% complete response rate, with median time to...
Recent Advances Raise Hopes of Better Addressing Richter Transformation
A new review synthesizes recent advances that clarify the biology of Richter transformation (RT), the aggressive lymphoma that develops in 2%‑10% of chronic lymphocytic leukemia (CLL) patients. The analysis confirms that 70%‑80% of RT cases are clonally related to the...
Analysis Finds Efficiencies, Savings of Using a Single Bispecific for DLBCL and FL
A new analysis quantifies the operational and financial benefits of using Genmab’s epcoritamab, a dual‑indication bispecific antibody, for both relapsed/refractory diffuse large B‑cell lymphoma (DLBCL) and follicular lymphoma (FL). In a community‑practice model of 100 patients, the study projects 3,110...
Stale Bread and Bacteria Could Power a New Era in Green Chemicals
Scientists at the University of Edinburgh's Wallace Lab engineered E. coli to generate hydrogen from simple sugars, including stale bread, and paired it with a palladium surface catalyst to hydrogenate organic molecules. The biocatalytic system achieved up to 99% conversion efficiency,...
Mixed Immune Signature Identified in Chronic Hand Eczema
A phase‑2b trial enrolling 94 adults with chronic hand eczema (CHE) without etiologic pre‑selection uncovered a mixed immune signature spanning type 2, type 3 and type 1 pathways. Dupilumab, an IL‑4Rα antagonist, delivered a 59.8% mean improvement in modified Total Lesion Symptom Score...
Inside Lemnisca’s Big Leap For Digital Twins To Make Biotech More Scalable
Lemnisca, a Bengaluru startup, is launching a digital‑twin platform that models fermentation at industrial scale, merging microbial biology with physical process conditions. The hybrid model, paired with an in‑house wet lab, creates a feedback loop that refines simulations and cuts...
GLP-1 News Galore; Top 100 Venture Investors; Doug Ingram to Step Down; and More
This week’s Endpoints Weekly highlighted a surge of GLP‑1 developments, including new trial data and expanded indications that reinforce the class’s dominance in obesity and diabetes treatment. The newsletter also released its annual Top 100 venture investors list, showing a notable...
EMA’s CHMP Recommends Three New Orphan Drugs, Rebuffs Two FDA-Approved Programs
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended six new medicines, including three orphan drugs already approved by the FDA—Ojemda for pediatric low‑grade glioma, Palsonify for acromegaly, and Xolremdi for WHIM syndrome. The agency also gave a...
Emerging Models Point to a New Operating System for Rare Disease Innovation
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