Calla Lily Clinical Care Doses First Patients in Clinical Trial for Intravaginal Drug Delivery Platform for Threatened Miscarriage
Calla Lily Clinical Care has begun dosing the first participants in the FREEDOM clinical trial, testing its 400 mg intravaginal progesterone product Callavid. The NIHR‑funded study targets women with luteal phase insufficiency, a condition linked to threatened miscarriage and infertility. Callavid’s leak‑free, tampon‑like device seeks to replace traditional vaginal pessaries, which often leak and compromise dosing consistency. The trial will assess safety, user acceptability, and hormone absorption to validate the platform’s potential as the first drug‑device combo for miscarriage support.
CellCentric Raises $220M to Get Multiple Myeloma Pill to Market
CellCentric, a 22‑year‑old transatlantic biotech, closed a $220 million Series D round to accelerate development of its oral multiple myeloma drug. The capital will fund the completion of Phase III trials, scale manufacturing, and prepare regulatory filings. The therapy is designed for patients...
Pfizer, Lilly, More Report Q1, FDA Names Acting CBER Director and an ALS Awakening
Pfizer posted first‑quarter earnings that topped consensus estimates, yet analysts deemed the beat insufficient given higher expectations for the New York‑based giant. Eli Lilly delivered a striking 56% revenue surge, though the company noted that price reductions on several products capped its...
Bayer to Buy Perfuse Therapeutics for $300M Upfront
Bayer announced a $300 million upfront payment to acquire ophthalmology biotech Perfuse Therapeutics, securing its mid‑stage program aimed at the leading causes of blindness. The transaction represents Bayer’s first pharmaceutical merger‑and‑acquisition in several years, signaling a renewed focus on specialty eye...
Capturing True Single-Cell Resolution with Your Spatial Data
Spatial biology has transformed life‑science research, yet imaging and sequencing platforms still grapple with cell‑boundary segmentation and grid‑based spot limitations. Linda Orzolek of OMAPiX explains how Takara Bio’s Trekker technology delivers true single‑cell spatial resolution by isolating nuclei and pairing...
Signadori Bio Raises €11M to Advance Tumour Platform
Signadori Bio announced an €11 million ($11.9 million) seed extension to fund its in‑vivo monocyte engineering platform for solid tumours. The Series A round, led by Taiho Ventures with Sofinnova and Invivo Partners, will support lead candidate nomination, platform refinement, and team expansion...
Novo Nordisk's Q1 in Four Words: Pills, Pricing, Payments and Pressure
Novo Nordisk’s first‑quarter performance centered on its obesity drug Wegovy, which now serves roughly one million patients in the United States. The company is navigating heightened pricing pressure as insurers push for larger rebates while regulators scrutinize the drug’s cost....
FDA Approves Incyte’s Once‑Daily Jakafi XR for Myelofibrosis, Polycythemia Vera and GVHD
The U.S. FDA has approved Incyte’s Jakafi XR, a once‑daily extended‑release ruxolitinib tablet, for adults with intermediate‑ or high‑risk myelofibrosis, polycythemia vera patients who cannot use hydroxyurea, and patients 12 years and older with certain graft‑versus‑host disease forms. The decision follows...
Can Mammals Regrow Lost Limbs? This New Treatment Could Be the First Step
Researchers at Texas A&M have demonstrated that a two‑step treatment using growth factors FGF2 and BMP2 can trigger partial digit regeneration in mice. The protocol first applies FGF2 to create a blastema‑like cell mass, then adds BMP2 to drive bone...
Understanding Potential Ocular Side Effects of Injectable GLP-1 Medications
Recent research suggests a rare but serious link between the GLP-1 receptor agonist semaglutide (Ozempic, Wegovy) and non-arteritic anterior ischemic optic neuropathy (NAION), a form of eye stroke that can cause permanent vision loss. A 2026 JAMA Network Open study...
Sickle Cell Disease After Casgevy: Seven Companies to Watch in 2026
Casgevy’s $2.2 million, ex vivo CRISPR cure proved sickle cell disease can be edited at its genetic root, but its complex manufacturing and conditioning limit broad access. In response, a wave of innovators is targeting simpler, safer, and more scalable solutions—from Beam’s...
Cytospire Therapeutics Secures £61m to Advance Cancer Treatment
Cytospire Therapeutics, a UK biotech, closed a £61 million (≈$77 million) Series A round to accelerate its multispecific engager antibody platform. The capital will fund the development of its lead candidate, CYT X300, aimed at EGFR‑positive solid tumours such as colorectal, head‑and‑neck and non‑small‑cell...
Furin‐Mediated Intracellular Aggregation of Radioactive Molecules for Enhanced Radionuclide Imaging and Tumor Therapy
Researchers have engineered a furin‑responsive radioactive probe, RVRR‑TPE, that self‑assembles into nanoparticles inside furin‑positive cancer cells. The molecule couples a furin‑cleavable Arg‑Val‑Arg‑Arg peptide, an aggregation‑induced emission fluorophore (tetraphenylethene), and a phenol group for iodine‑125/131 labeling. In mouse models, the 125I/131I‑labeled...
STAT+: Even at a Meeting in Rome, FDA Shifts Are Top of Mind for Gene Therapy Field
At a gene‑therapy summit in Rome, Tim Hunt highlighted recent FDA approvals of rare‑disease treatments from Rocket Pharmaceuticals and Regeneron as signs of progress. He also flagged the departure of Vinay Prasad, the FDA’s top regulator for cell and gene therapies,...
Caris Launches Caris MI Clarity for AI-Powered Breast Cancer Recurrence Risk Assessment
Caris Life Sciences has introduced Caris MI Clarity, an AI‑driven prognostic test that evaluates both early (0‑5 years) and late (5‑15 years) distant recurrence risk for postmenopausal patients with HR‑positive/HER2‑negative, node‑negative early‑stage breast cancer. The assay analyzes digitized H&E pathology...
Hierarchically Multifunctional Fiber‐optic Theranostic Probe for Cancer Photothermal‐photodynamic Synergism
Researchers have created a hierarchically multifunctional fiber‑optic probe that simultaneously measures dissolved oxygen and delivers combined photothermal‑photodynamic therapy. The three‑layer architecture isolates an Ru(dpp) oxygen sensor, an ICG photosensitizer, and a CaO2@LA oxygen‑generating layer, eliminating optical crosstalk and counteracting tumor...
Multi4 Medical Receives CE Mark Approval for Multi4 System to Perform Outpatient Bladder Cancer Treatment
Multi4 Medical has secured CE mark approval for its Multi4 System, an integrated endoscopic platform that enables bladder cancer treatment in a single outpatient visit. The device delivers local anesthesia, performs tumor resection, extracts tissue for pathology, and cauterizes—all without...
Microbiome Explorer Challenge Returns Seeking Europe’s Next Microbiome Start-Up Stars
The Microbiome Explorer Challenge (MEC) returns for its 2026 edition, expanding from a Central‑Eastern European focus to cover the entire continent. It invites pre‑seed, seed‑stage startups and research spin‑outs to submit market‑ready concepts for personalized microbiome modulation across gut, skin,...
With Large DNA Fragment Assembly, Scientists Can Design Microbes that Produce Countless Complex Products
A new review in Quantitative Biology shows scientists can now reliably assemble very large DNA fragments, enabling the construction of whole metabolic pathways and even extra chromosomes inside microbes. This capability turns yeast and bacteria into efficient cell factories that...
Addressing Treatment Gaps in Gout
In this episode, Crystallis Therapeutics CEO James McKay explains the biology of gout, why existing urate‑lowering drugs often fail, and how the company’s next‑generation URAT1 inhibitor, detenurad, aims to close the large treatment gap for moderate‑to‑severe patients. He highlights that...
Popular GLP-1 Drugs Significantly Reduce Major Cardiovascular Events,
A systematic review and meta‑analysis of eleven cardiovascular outcome trials involving 91,490 high‑risk patients found that GLP‑1 receptor agonists reduce major adverse cardiovascular events (MACE) by 14% compared with placebo. The therapy also lowered cardiovascular mortality by 13% and improved...
Bacteria: Unsung Players in the Tumor Microbiome
Recent consensus research highlights that every tumor harbors its own low‑biomass microbiome, influencing cancer development, metastasis, and treatment response. Researchers, led by Maria Rescigno, emphasize the need for rigorous detection methods—favoring 16S rRNA sequencing and culturomics—to distinguish genuine microbes from...
Direct Protein Reading Platform Ends Proteomics Blind Spot
🐠 Everything we know about biology has been built on an incomplete picture. DNA tells us what a cell might do. Proteins tell us what it’s actually doing. Pumpkinseed announced their $20M Series A today (led by Future Ventures and NfX)...
FDA Clears IND for Cellenkos' CK0802, First‑in‑Class Treg Therapy for Steroid‑Refractory GVHD
Cellenkos announced that the U.S. FDA has cleared its Investigational New Drug application for CK0802, enabling a multicenter Phase 1b/2a study in steroid‑refractory graft‑versus‑host disease. The trial, set to begin in the second half of 2026, aims to assess safety...
Lupin Secures FDA Approval for Generic Glycerol Phenylbutyrate Oral Liquid for UCDs
Lupin Limited won U.S. FDA clearance for its glycerol phenylbutyrate oral liquid, a generic version of Horizon Therapeutics' Ravicti, to treat chronic urea cycle disorders. The approval gives patients a new, potentially lower‑cost option and marks Lupin's expanding footprint in...
FDA Grants First Oral SERD Approval to Arvinas' Vepdegestrant for ESR1‑Mutant Breast Cancer
The FDA approved Arvinas' oral selective estrogen receptor degrader (SERD) vepdegestrant for ESR1‑mutant advanced breast cancer, citing a hazard ratio of 0.57 and a median progression‑free survival of 5.0 months versus 2.1 months on fulvestrant. The decision came five weeks...
“Sounds Great. Do You Want FDA Approval?” A Regulatory Analysis of Psychedelics
On April 18, 2026 President Trump signed an executive order compelling the FDA to prioritize review of psychedelic drugs, issuing priority‑review vouchers for three compounds already holding Breakthrough Therapy designation. The order also creates a Right‑to‑Try pathway for ibogaine, directs...
World's First Vaccine for Lyme Disease Could Be Available in 2027
Pfizer and French partner Valneva announced that their Lyme disease vaccine candidate PF‑07307405 (LB6V) achieved 73.2% efficacy in Phase III trials involving more than 9,000 participants. Although the study missed its primary statistical endpoint due to a low incidence of cases,...
FDA Expands Compassionate Use of Daraxonrasib for Metastatic Pancreatic Cancer
The U.S. FDA has approved an expanded‑access protocol for daraxonrasib, Revolution Medicines' KRAS‑G12D inhibitor, allowing patients with pretreated metastatic pancreatic cancer to receive the drug. The decision follows phase‑3 data that doubled survival versus standard second‑line chemotherapy, addressing a disease...
Converge Bio’s AI Platform Doubles Cetuximab Affinity in Eight Hours
Converge Bio announced that its generative‑AI platform ConvergeAB produced a cetuximab antibody with more than double the binding strength to EGFR in an eight‑hour, zero‑shot experiment. The result, filed as a provisional patent, highlights AI’s capacity to accelerate and refine...
Janus Nanomotors Offer Active Delivery for Radiation‑Induced Dermatitis
A team of nanotech researchers has introduced Janus nanomotors that autonomously move through irradiated skin to deliver anti‑inflammatory drugs, markedly reducing radiation‑induced dermatitis in animal studies. The technology converts skin‑generated hydrogen peroxide into propulsion, enabling targeted therapy with minimal systemic...
Hemophilia A Therapy by Expression Gets FDA Fast-Track, Pediatric Designation
The U.S. FDA awarded fast‑track and rare pediatric disease designations to Expression Therapeutics' investigational stem‑cell therapy for hemophilia A. The designations promise more frequent regulator interaction, rolling review, and eligibility for a priority‑review voucher, accelerating a potentially curative, one‑time treatment.
EyePoint Inc (EYPT) Q1 2026 Earnings Call Transcript
EyePoint Pharmaceuticals reported a dramatic revenue drop to $600,000 for the quarter, reflecting the reversal of deferred YUTIQ license revenue, while operating expenses surged to $71 million as Phase 3 trials for its DuraVu platform intensified. The company posted a net loss...
Vanda Pharmaceuticals Inc (VNDA) Q1 2026 Earnings Call Transcript
Vanda Pharmaceuticals reported Q1 2026 net product sales of $51.7 million, a modest 3% year‑over‑year increase driven primarily by a 26% surge in Fanapt revenue and a 32% rise in prescriptions. Hetlioz sales continued to decline, falling 24% YoY amid generic...
Bio-Techne Corp (TECH) Q3 2026 Earnings Call Transcript
Bio-Techne reported flat Q3 revenue of $295.9 million, with a 2% foreign‑exchange gain offset by a 2% headwind from businesses held for sale. Adjusted operating margin expanded to 31.1%, up roughly 100 basis points year‑over‑year, while adjusted EPS rose 10%...
Taysha Gene Therapies Inc (TSHA) Q1 2026 Earnings Call Transcript
Taysha Gene Therapies announced that its Rett syndrome gene therapy TSHA-102 has moved into pivotal development, securing FDA Breakthrough Therapy designation and written alignment on both the REVEAL pivotal and ASPIRE trial designs. Early Phase 1/2 data showed a 100%...
Urogen Pharma Ltd (URGN) Q1 2026 Earnings Call Transcript
UroGen Pharma reported a $15.8 million 2025 revenue for its newly launched Zasturi, with the permanent J code effective Jan. 1 2026 spurring a sharp uptick in prescriber and site adoption. The company now has 838 activated sites, over 95% payer access, and...
Sarepta Therapeutics Inc (SRPT) Q1 2026 Earnings Call Transcript
Sarepta Therapeutics reported $1.86 billion net product revenue for 2025, a 16% increase, and ended the year with $954 million in cash and investments. Management guided 2026 net product revenue to $1.2‑$1.4 billion, emphasizing a low‑end outlook while targeting operating profit and positive...
Madrigal Pharmaceuticals Inc (MDGL) Q1 2026 Earnings Call Transcript
Madrigal Pharmaceuticals reported its Q1 2026 earnings, highlighting that Rezdiffra generated $958 million in net sales for its first full year, nearly $1 billion in total revenue. Patient enrollment rose to 36,250, reflecting strong sequential growth in the expanding MASH market. The...
Novavax Inc (NVAX) Q1 2026 Earnings Call Transcript
Novavax reported a Q1 2019 net loss of $43.2 million, improving from the prior year, while revenue fell 59% to $4 million as the Bill & Melinda Gates Foundation grant wound down. The company highlighted clinical milestones for its RSV vaccine ResVax,...
Quanterix Corp (QTRX) Q1 2026 Earnings Call Transcript
Quanterix Corp reported fourth‑quarter revenue of $43.9 million, a 25% year‑over‑year increase and 7% sequential growth, though organic revenue fell 22% as both Simoa and Spatial platforms declined over 20%. The company highlighted a $897 CMS reimbursement rate for its Lucent...
Expanding the Human Proteome with Microproteins and Peptideins
An international consortium led by the TransCODE project has established a rigorous workflow to annotate non‑canonical open reading frames (ncORFs) and their encoded microproteins as reference human proteins. By expanding the PeptideAtlas platform, the team analyzed billions of mass‑spectrometry spectra,...
Zevra Therapeutics Inc (ZVRA) Q1 2026 Earnings Call Transcript
Zevra Therapeutics reported Q1 2026 net revenue of $36.2 million, a 78% year‑over‑year increase, driven primarily by MyPlifer sales of $24.6 million and a $10.2 million expanded‑access program. The company completed the $50 million divestiture of its SDX portfolio, recorded a $43.3 million one‑time gain...
Mineralys Therapeutics Inc (MLYS) Q1 2026 Earnings Call Transcript
Mineralys Therapeutics reported Q1 2026 results highlighting FDA acceptance of lorundrostat’s NDA with a PDUFA target of Dec 22, 2026. The company completed five trials showing durable blood‑pressure reductions, though the EXPLORER‑OSA study missed its primary AHI endpoint, it still demonstrated a...
Piezoelectric MXene Scaffold Promotes Cartilage Repair While Limiting Vessel Growth
Researchers unveiled an origami‑folded PLLA/MXene scaffold that converts joint motion into piezoelectric signals and, when exposed to near‑infrared light, generates mild heat. The dual‑modality design doubles electrical output versus pure PLLA and reaches ~41 °C, a temperature that suppresses VEGF‑driven angiogenesis...
Cytokinetics Scores Late-Stage Win in Non-Obstructive HCM as BMS Plans Camzyos Restart
Cytokinetics announced that its experimental drug Myqorzo (aficamten) achieved both primary endpoints in the Phase III ACACIA‑HCM trial, marking the first late‑stage success for a therapy targeting non‑obstructive hypertrophic cardiomyopathy (HCM). The result propelled the company’s stock up 17%, pushing its...
Scientists Map Genetic Switches on Mosquito Reproductive Genes, Advancing Tools to Fight Disease
Scientists at Keele University have produced the first detailed map of cis‑regulatory elements that govern reproduction in Anopheles gambiae, the primary malaria vector. The atlas identifies hundreds of genetic switches and the exact nucleotides that drive germline expression in both...
Nastent Nasal Insert Outperforms CPAP in Compliance
Your doctor will not tell you this. Most CPAP patients hate it and abandon it within months. Their oxygen crashes at night. Their mitochondria suffer. Their glymphatic system cannot clear amyloid beta. A clinical trial just completed on Nastent. It is...
Blocking IGF1 Senescence Reverses Hair Follicle Aging
Targeting IGF1‐Induced Cellular Senescence to Rejuvenate Hair Follicle Aging - Wang - 2025 - Aging Cell - Wiley Online Library https://t.co/LwbNFih66G
Advances in Genetic Medicine Took Center Stage at INSAR
At INSAR in Prague, researchers highlighted a surge of genetic‑medicine breakthroughs aimed at autism, focusing on rare variants such as SCN2A, SHANK3 and UBE3A. Techniques ranging from CRISPR gene editing to antisense oligonucleotides and epigenome editing demonstrated tangible symptom improvements,...