Today's Pharma Pulse
Ona lands $86.6M Series B, one of Spain’s biggest biotech financings
Spanish biotech Ona announced a $86.6 million Series B round, ranking among the largest venture financings in Spain’s life‑science sector this year. The round was led by Seventure Partners with participation from existing backers and new strategic investors. The funds will expand Ona’s AI‑driven drug discovery platform and accelerate its pre‑clinical pipeline.
Spyre Therapeutics Jumps 25% on Positive Phase 2 SKYLINE Data
Spyre Therapeutics (SYRE) surged 25.07% to $64.15 after reporting encouraging 12‑week induction data from Part A of its Phase 2 SKYLINE trial for ulcerative colitis. The move lifted the stock from $51.29 the prior close and triggered a surge in trading volume, underscoring investor confidence in the candidate’s potential as a best‑in‑class anti‑a4ß7 therapy.
The Next Frontier in Precision Oncology
Precision oncology is shifting from static, single‑biopsy analyses toward dynamic, multi‑omics platforms that integrate genomics, proteomics, spatial biology and longitudinal clinical data. Over the next decade, AI will move from pattern‑recognition to causal reasoning, offering clinicians interpretable predictions that anticipate...
Base Editing Repairs Mutation and Liver Function in Mouse Model of Zellweger Spectrum Disorder
Scientists at the Broad Institute and collaborators used a refined base‑editing system to correct a disease‑causing mutation in the PEX1 gene of mice that model Zellweger spectrum disorder. The edit restored peroxisome function and normalized liver biomarkers, demonstrating functional rescue...
Can Phage Therapy Answer the Booming Antibiotic Resistance Problem?
Antibiotic‑resistant infections cause nearly 5 million deaths annually, prompting renewed interest in bacteriophage therapy. Companies such as Armata Pharmaceuticals, TechnoPhage, and Locus Biosciences have reported positive clinical milestones, including Armata’s QIDP‑designated AP‑SA02 moving toward a phase 3 trial and TechnoPhage’s phase 2b study...
DDW Highlights: 14 April 2026
In this episode, Bruno Quinney highlights three major developments: the discovery of a new recessive neurodevelopmental disorder linked to mutations in the non‑coding gene RNU4‑2, a first‑in‑human trial of personalized CAR‑T cell therapies for hard‑to‑treat solid tumors in children, and...
Psychedelic Therapy and Traditional Antidepressants Show Similar Results Under Open-Label Conditions
A meta‑analysis of 24 trials found that psychedelic therapy and open‑label antidepressants produce statistically indistinguishable reductions in depressive symptoms. The study compared 8 psychedelic trials (249 patients) with 16 antidepressant trials (7,921 patients) under equal unblinding conditions, revealing only a...
Helical Closes $10M Seed to Turn Bio Foundation Models Into Systems
Helical, a London‑based pharma‑AI startup, closed a $10 million seed round led by redalpine, with AI leaders from Cohere and HuggingFace among angel investors. The funding will expand its dual‑surface platform—Virtual Lab for biologists and Model Factory for data scientists—across more...
Helical Secures $10M to Advance Virtual AI Lab for Pharma Research
Helical, a biotech startup founded in early 2024, announced a $10 million seed round led by redalpine with participation from Gradient, BoxGroup, Frst and AI industry angels. The company’s virtual AI lab combines foundation model outputs with biological validation to create...
Anavex Shows Promise, but EMA Hurdles Loom
Macro: autophagy links autism & Alzheimer’s. Key: Anavex blarcamesine restores autophagy; positive Phase IIb/III data. Risk: EMA pushback. Insight: speculative long, tight stop. 🔬 — Viktor Kopylov, PhD, CFA More insights: t.me/si14Kopylov
The FDA Said NO to a New Vaccine; Then Suddenly Said YES; and the Guy Who Said NO Was Gone.
The FDA initially refused to review an experimental RNA flu vaccine, then abruptly reversed its stance after apparent pressure from the White House. The agency’s vaccine chief left the organization shortly after the policy shift, fueling speculation about internal conflict....
SynOx Therapeutics Reports Topline P-III (TANGENT) Trial Results on Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)
SynOx Therapeutics announced topline data from its global Phase 3 TANGENT trial, which evaluated emactuzumab (1,000 mg every two weeks for five doses) versus placebo in patients with tenosynovial giant cell tumor (TGCT). The study met both primary efficacy endpoints, showing a...
Parker Institute Doubles Down on Cancer Vaccines as Part of Ongoing Reboot
The Parker Institute for Cancer Immunotherapy announced a renewed focus on mRNA‑based cancer vaccines, launching a multi‑year program that will fund clinical trials and partner with biotech firms. The initiative includes a $200 million investment pool aimed at accelerating vaccine design,...
Exclusive: Redesign Health-Backed Starfire Launches to Help Pharma Commercialize Therapies
Starfire, backed by Redesign Health, has launched an agentic commercial intelligence platform aimed at helping pharmaceutical and biotech firms commercialize therapies. The AI‑driven system overlays both external and internal data to automate patient‑journey analyses, cost‑outcome models, and executive‑ready presentations. Redesign...
Nature Study Links Genetics to Unpredictable GLP‑1 Weight‑Loss Drug Response
Researchers at 23andMe published a Nature paper showing that genetics, ancestry, age and health status explain only a quarter of the variability in GLP‑1 weight‑loss drug response, leaving three‑quarters of outcomes unexplained. The findings challenge the confidence biohackers place in...
Revolution Medicines' Daraxonrasib Shows Survival Gain, Stock Up 39%
Revolution Medicines announced that its RAS(ON) inhibitor daraxonrasib more than doubled median overall survival in a Phase 3 trial for metastatic pancreatic cancer, achieving a 13.2‑month median versus 6.7 months with chemotherapy. The data sparked a 39% surge in the company’s...
The Biotech Bi-Weekly: Expanding the Reach of T-Cell Engagers in Solid Tumors, a Next-Generation Chemiluminescent Immunoassay Platform and AACR Exhibitor...
The biotech bi‑weekly highlights several product launches and site expansions unveiled at the AACR Annual Meeting. Deck Bio introduced a multi‑target T‑cell engager platform aimed at overcoming heterogeneity in solid‑tumor immunotherapy. Abcam released SimpleStep Ignite™, a chemiluminescent ELISA that delivers...
Lübeck Conference Launches Annual Nanotech‑Life Sciences Forum
Fraunhofer IMTE and Nano in Germany e.V. inaugurated the first annual International Conference on Nanotechnology and Life Sciences in Lübeck, gathering researchers, industry leaders, and policymakers. The event showcased magnetic nanoparticle synthesis, magnetic particle imaging, and highlighted Bavaria’s growing biotech...
Biohaven Shares Surge 10% as Canaccord Analyst Initiates Coverage with $21 Price Target
Biohaven Pharmaceutical rose more than 10% on Monday after Canaccord Genuity analyst Sumant Kulkami initiated coverage with a bullish buy recommendation and a $21 price target. The analyst highlighted the company’s phase‑3 opakalim trial for focal epilepsy as the catalyst...
Does the History of Insulin Rhyme with GLP-1s?
Liam Shaw’s essay draws a parallel between the debut of insulin and today’s GLP‑1 receptor agonists, arguing that both transformed their respective diseases while spawning new complexities. Insulin’s miracle cure introduced issues of affordability, access, and treatment intensification, a pattern...
How Serious Is the Biosimilar Void?
The FDA released a draft guidance in March 2026 that would drop certain pharmacokinetic (PK) studies, easing biosimilar development and cutting costs. Samsung Bioepis SVP Thomas Newcomer says a biosimilar void still exists in the U.S., especially for mid‑volume and...
Building Operational Visibility in Clinical Trials: Q&A with Deepak Prakash
Identiv VP Deepak Prakash explains how RFID and Bluetooth‑enabled tracking is reshaping clinical trial operations by delivering continuous, real‑time visibility of assets, samples, and shipments. The technology replaces fragmented, manual data entry with automated condition monitoring, cutting reconciliation costs and...
Can a Transplant Cure Aging? | Catherine Baucom MD PhD
In this episode, Dr. Robert Lovekin talks with Dr. Catherine Baucom, chief medical officer of MitoSense, and veteran health expert Van about mitochondrial organelle transplantation—a novel therapy that injects healthy mitochondria from young donors into patients to repair damaged cells....
Implications of Tecvayli Plus Darzalex Faspro Demonstrating 83% Reduction in Disease Progression or Death.
Johnson & Johnson’s Tecvayli (teclistamab) combined with Darzalex Faspro (daratumumab) achieved an 83% reduction in disease progression or death in a Phase III trial for relapsed/refractory multiple myeloma. The study, presented at ASH, reported a hazard ratio of 0.17, higher response rates,...
The Secret History of the FDA
The Brownstone Institute’s latest post argues that the FDA was created as an industry‑controlled agency to rescue failing meat‑packing and biologics sectors, embedding regulatory capture from its inception. It claims this origin explains why reforms face entrenched resistance and why...
Vir Biotechnology Doses First Patient in Phase I VIR-5500 Trial
Vir Biotechnology has dosed the first patient in the expansion cohort of its Phase I trial of VIR‑5500, a PSMA‑targeted, dual‑masked T‑cell engager, for late‑line metastatic castration‑resistant prostate cancer (mCRPC). The cohort uses a step‑up regimen of 800/2000/3500 µg/kg every three weeks...
FDA Approves Travere's Filspari as First Drug for the Kidney Disease FSGS
The U.S. Food and Drug Administration has broadened the label for Travere Therapeutics' drug Filspari, adding a second kidney indication to its approval. Filspari, a dual endothelin‑angiotensin receptor antagonist, was already the first therapy cleared for primary focal segmental glomerulosclerosis...
Boehringer Ingelheim Launches LENZELTA Mastitis Vaccine for Dairy Cattle in European Union
Boehringer Ingelheim has secured an FDA Emergency Use Authorization for its IVOMEC® 1% ivermectin injection, allowing it to prevent New World screwworm infestations in cattle at key intervention points. The EUA permits treatment within 24 hours of birth, at castration,...
Opinion: My Brother Can’t Access a Just-Approved Breakthrough Drug for His Rare Disease
A newly FDA‑approved breakthrough drug promises to address the neurological degeneration that has long plagued patients with Hunter syndrome, a rare lysosomal disorder. While the approval marks a scientific milestone, patients like the author’s 28‑year‑old twin brother still face barriers...
For Ben Sasse, Revolution Medicines’ Pancreatic Cancer Trial Felt Like His Best, only Option
Former U.S. senator Ben Sasse was diagnosed with metastatic pancreatic cancer in December and promptly enrolled in an early‑phase trial of Revolution Medicines' targeted drug daraxonrasib. The therapy, positioned as a first‑line option, aims to extend both the quantity and...
Travere Therapeutics Reports FDA Full Approval of Filspari for Proteinuria Reduction in FSGS
Travere Therapeutics announced that the U.S. Food and Drug Administration has granted full approval to Filspari (sparsentan) for reducing proteinuria in patients aged eight years and older with focal segmental glomerulosclerosis (FSGS) who do not have nephrotic syndrome. The approval...
Sequence Identities and Functional Definitions - Where Is the Limit? (T 0137/24)
The EPO Board of Appeal in T 0137/24 upheld a cannabis‑producing yeast patent by ruling that selecting a higher amino‑acid sequence identity from a convergent list does not add matter. The board found the claim’s functional definition of enzyme activity sufficient,...
Daiichi Sankyo and Merck Receives FDA’s Priority Review for Ifinatamab Deruxtecan (I-DXd) to Treat ES-SCLC
Daiichi Sankyo and Merck have secured FDA priority review for ifinatamab deruxtecan (I‑DXd) under the Real‑Time Oncology Review and Project Orbis programs. The decision follows a successful Biologics License Application based on the Phase II IDeate‑Lung01 trial, which enrolled 187 extensive‑stage...
Eli Lilly Reports P-III (BRUIN CLL-322) Trial Data on Jaypirca Combination for CLL/SLL
Eli Lilly announced that its phase‑III BRUIN CLL‑322 trial showed the Jaypirca (pirtobrutinib) + venetoclax + rituximab regimen significantly extended progression‑free survival in relapsed or refractory CLL/SLL compared with venetoclax + rituximab alone. Patients were treated for roughly two years before entering a therapy‑free interval, and the benefit...
Novo Nordisk Partners with OpenAI to AI-Power Drug Development
Novo Nordisk announced a strategic partnership with OpenAI to embed advanced artificial‑intelligence across its drug discovery pipeline. The collaboration will leverage OpenAI’s models to sift through massive datasets, accelerate candidate selection and shorten regulatory submission timelines via the NovoScribe platform....
Rollout of Powerful New HIV Prevention Tool in Lower Income Countries Gets a Boost
The U.S. State Department and the Global Fund announced a major scale‑up of Gilead’s long‑acting HIV prevention drug lenacapavir, targeting 3 million people in low‑income countries over the next three years—a 50 % increase from the original 2 million commitment. Lenacapavir, which showed...
Federal Circuit’s Holding on Patent Eligibility for Engineered Host Cells Dovetails With PERA
The Federal Circuit ruled in REGENXBIO v. Sarepta that a host cell engineered to contain an AAV capsid gene plus a heterologous non‑AAV sequence is patent‑eligible under 35 U.S.C. §101. The opinion leans on the Chakrabarty precedent and distinguishes Myriad by emphasizing the material...
Entropy Neurodynamics' TRP-8803 Trial Shows Repeatable Psychedelic Effects in BED Study
Entropy Neurodynamics (ASX: ENP) reported that the third patient in its TRP‑8803 IV‑infused psilocin trial for binge‑eating disorder completed two doses and exhibited a repeatable psychedelic response. The trial, designed for 12 participants across two cohorts, is nearing the end...
STAT+: Maryland State Affordability Board Sets Its First Price Cap for a Medicine
Maryland's Prescription Drug Affordability Board announced its first price cap, targeting the type‑2 diabetes drug Jardiance. Starting January 2027 the state will limit a 30‑day supply to $204, roughly $6.80 per pill. The cap, modeled after Medicare’s maximum fair price...
Biden FDA Knew About COVID Vaccine Stroke Risk and Kept Americans in the Dark
Senate investigators reviewing roughly 2,000 pages of federal records say the FDA and CDC identified a potential ischemic‑stroke risk linked to Pfizer’s bivalent COVID‑19 booster for adults over 65 as early as October 2022. The agencies documented 226 stroke cases...
Pfizer’s Oncology Sales Poised for Growth Ahead of Q1 Earnings
Pfizer is expected to report rising oncology sales in its Q1 2026 earnings, driven by strong performance of Xtandi, Lorbrena and the Braftovi‑Mektovi combo. The company’s recent Seagen acquisition and expanding biosimilar portfolio add further upside, while generic pressure on...
RevMed’s Pancreatic Cancer Win Strengthens the Case for Targeting RAS(ON)
RevMed reported a positive Phase 2 trial of its RAS(ON) inhibitor in patients with advanced pancreatic ductal adenocarcinoma, showing a 23% objective response rate and a median progression‑free survival of 5.8 months. The study enrolled 45 heavily pre‑treated patients and...
GSK Moves Ovarian Cancer ADC Mo-Rez Into Five Phase 3 Trials
GlaxoSmithKline said its experimental ovarian‑cancer antibody‑drug conjugate, Mo-rez, will be tested in five Phase 3 studies following encouraging early‑stage results. The move expands GSK’s oncology portfolio and signals a renewed focus on high‑unmet‑need cancers.
Crossing the SynBio Valley of Death with Proven Solutions
Most synbio companies die between "works in the lab" and "works at scale." Freedom-to-operate issues, process robustness, CMC readiness. The valley of death is real and it swallows good science. @IngenzaLtd has been helping teams cross it for 20 years. Leonardo Magneschi...
Lilly to Acquire CrossBridge Bio in $300 M Deal
NEW: Eli Lilly has agreed to acquire CrossBridge Bio, the Houston-based ADC specialist led by @Mykalt45 I talked with Michael Torres on his run as a first-time CEO ending with a potential $300M deal: https://t.co/PPk3ZWL5SR
Legato Merger Corp III (LEGT) Q1 2026 Earnings Call Transcript
Legend Biotech reported a 66% year‑over‑year jump in CARVYKTI net trade sales to $555 million, driving total revenue to $306 million and narrowing the operating loss to $20 million. Gross margins held at 61% while manufacturing capacity reached 10,000 doses with a 97%...
TVTX Surges 45% After FDA Approval, Long Calls Lead
$TVTX jumps 45% on FDA approval, always liked this one, continues to work 5K Apr. 32.5 long calls leads the way https://t.co/g7Ga8FIJve
SGLT2 Inhibitors Protect Kidneys, Yet Raise Non‑Renal Risks
Sodium-Glucose Cotransporter-2 Inhibitors and Acute Kidney Injury Risk: A Systematic Review and Meta-Analysis of Randomized Trials "SGLT2is conferred substantial renoprotective benefits but increases the risk of certain nonrenal AEs." https://t.co/n0yhZgcShy
Clinical Innovations and Future Directions of Nanoparticles in the Treatment of Psychiatric and Neurological Disorders
Nanoparticles are emerging as a transformative platform for treating psychiatric and neurological disorders such as depression, schizophrenia, Alzheimer’s disease and Parkinson’s disease. Their physicochemical design enables crossing the blood‑brain barrier, targeted drug delivery, and enhanced imaging for early diagnosis. The...
Proline‑mediated Dichloromethyl Tagging Enables Ultra‑pure Drug Synthesis
A new method uses the amino acid proline to precisely attach dichloromethyl groups to complex molecules, enabling ultra-pure drug synthesis with built-in quality control and expanding possibilities for advanced medicine design. drugdiscovery
2026 340B Program Update – 340B Rebate Model RFI Comments Due and Manufacturers Continue Restricting 340B Pricing
The Health Resources and Services Administration (HRSA) has extended the comment deadline for its proposed 340B rebate‑model pilot to April 20, 2026, giving covered entities extra time to outline operational and financial impacts. At the same time, Eli Lilly and Novo Nordisk have instituted...