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.
Ionis Pharmaceuticals’ SWOT Analysis: Stock Gains Momentum on FDA Approval
Ionis Pharmaceuticals (NASDAQ:IONS) secured FDA approval for REDEMPLO, the first siRNA therapy targeting familial chylomicronemia syndrome (FCS), in November 2025. The drug’s clean label, quarterly at‑home dosing and broad indication have positioned it for rapid uptake, with payer agreements covering over 85% of U.S. lives. Ionis reported a 47.5% revenue surge to $1.06 billion and a 129% stock gain over the past year, prompting a $50 million upward revision to its 2025 guidance. The company now looks to a wave of Phase 3 readouts in Q3 2026 to broaden its RNA‑targeted pipeline and address larger triglyceride markets.
Lilly's Retatrutide Cuts 30% Body Weight, New GLP‑1 Studies Target Plateaus and Joint Inflammation
Lilly’s investigational triple‑agonist retatrutide delivered an average 30.3% weight loss after 104 weeks in a Phase 3 trial, matching bariatric‑surgery outcomes. At the same time, researchers uncovered cellular mechanisms that cause GLP‑1 weight‑loss plateaus and detected GLP‑1 hormone in arthritic joint...
FDA Finds No Definitive Child Deaths Linked to COVID‑19 Vaccines After Review of 96 Cases
The Food and Drug Administration reviewed 96 vaccine‑related death reports involving children and concluded that none were definitively linked to COVID‑19 shots. The finding directly challenges former FDA vaccine chief Dr. Vinay Prasad’s claim of at least ten unreported child...
EMA Starts Review of Regeneron's Otarmeni Gene Therapy for Genetic Hearing Loss
Regeneron Pharmaceuticals announced that the European Medicines Agency has accepted the Market Authorization Application for Otarmeni, its AAV‑based gene therapy targeting biallelic OTOF‑variant hearing loss. The acceptance moves the product into a formal EMA review, the first step toward potential...
Novo Nordisk's Oral Wegovy Pill Gets EU Approval Recommendation
Novo Nordisk announced that the European Medicines Agency’s CHMP has recommended marketing authorisation for its oral Wegovy pill, a semaglutide formulation that achieved a 16.6% average weight loss in trials. The recommendation paves the way for a European launch in...
FDA Clears AstraZeneca‑Daiichi Sankyo’s Datroway for Metastatic Triple‑Negative Breast Cancer
AstraZeneca and Daiichi Sankyo announced FDA approval of Datroway for adult patients with unresectable or metastatic triple‑negative breast cancer. The decision follows a Phase 3 trial that showed a 5‑month median overall‑survival gain, positioning the drug as a Category 1 preferred first‑line...
Venus Remedies Gets Saudi FDA Approval for Speciality Oncology Therapy
Venus Remedies Limited announced that the Saudi Food and Drug Authority has granted marketing authorisation for its specialty oncology drug Plerixafor, a stem‑cell mobiliser used in autologous transplants. This marks the first global approval for the therapy, positioning Saudi Arabia...
Gene-Based Therapies Could Transform Future Pancreatitis Treatment
Pancreatitis remains a largely untreatable inflammatory disease, with current care limited to symptom management. Gene‑based therapies—spanning augmentation, inhibition, and editing—are emerging to address the genetic drivers across lipid‑metabolism, trypsin regulation, ductal secretion, and ER‑stress pathways. Recent preclinical work shows AAV‑mediated...
Pharvaris to File FDA NDA for Oral Deucrictibant, First-in-Class HAE Therapy
Pharvaris announced it will submit an FDA New Drug Application for its immediate‑release oral deucrictibant by the end of June. The filing is backed by Phase 3 RAPIDe‑3 data showing symptom relief in a mean of 1.3 hours, far faster than the...
ASCO to Spotlight Pancreatic Cancer Innovation Beyond KRAS
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Fool.com Analysts Flag Abivax and Viking Therapeutics as Potential Double‑digit Gainers by 2030
Fool.com analysts project that Abivax (ABVX) and Viking Therapeutics (VKTX) could see their share prices double by 2030, driven by late‑stage trial readouts and expanding market opportunities. The forecast hinges on successful regulatory milestones for Abivax’s ulcerative colitis drug and...
Inocras Announces ASCO 2026 Online Publication: Whole-Genome HRD Phenotyping as a Predictor of PARP Inhibitor Benefit in First-Line Maintenance High-Grade...
Inocras announced that whole‑genome sequencing‑based HRD phenotyping predicts benefit from PARP inhibitor maintenance in high‑grade serous ovarian cancer. In a real‑world study of 84 patients at Severance Hospital, HRD‑positive tumors had a median progression‑free survival of 27.5 months versus 12.0...
New Indicator for Response to Therapy in Pediatric Cancers Identified
Researchers at the University of Birmingham reported that a high aneuploidy score can predict which children with relapsed solid tumors respond to a combined low‑dose irinotecan and PARP‑inhibitor regimen. The Phase I/II eSMART arm enrolled 70 patients across the UK, France,...
From Decades to Years - AI Could Speed Search for Brain Drugs Hiding in Plain Sight
Scientists at the UK Dementia Research Institute are using artificial intelligence to sift through patient data, voice recordings, eye scans and lab‑grown brain cells, aiming to repurpose existing drugs for neurological conditions such as motor neurone disease (MND). By training...
Imperagen Secures $6.7M Seed Funding to Fuse Quantum Physics, AI for Faster Enzyme Engineering
Imperagen announced a £5 million ($6.7 million) seed round led by PXN Ventures, with IQ Capital and Northern Gritstone participating. The Manchester spin‑out will use quantum‑physics simulations, AI models and robotic labs to cut enzyme‑engineering timelines, a capability that could reshape pharma...
Abivax Presents First Quarter 2026 Financial Results and Reports Three-Year Interim Data From Study 108, a Phase 2a/2b Open-Label Extension...
Abivax reported Q1 2026 results, highlighting €491.6 million (≈$540 million) in cash and a runway extending into Q4 2027. The company released three‑year interim data from Study 108, showing that 68% of 130 ulcerative colitis patients remained in clinical remission after 144 weeks of obefazimod...
Leukemia Drug HHT Delays Aging, Extends Mouse Lifespan
Homoharringtonine exhibits senotherapeutic activity that mitigates diet- and age-associated obesity and insulin resistance and extends lifespan in mice [an FDA-approved anti-leukemic drug; authors found that "HHT treatment delays aging and extends the lifespan in progeroid and aged mice"] https://t.co/LEegM8XUtR
Galderma Receives U.S. FDA Approval for Differin® Epiduo® Acne Gel Prescription-to-OTC Switch
Galderma announced that the U.S. FDA has approved Differin Epiduo® Acne Gel for over‑the‑counter sale to consumers aged 12 and older. The switch moves a prescription‑strength combination of adapalene 0.1% and benzoyl peroxide 2.5% into the retail market, leveraging more than...
FDA Approves Hepcludex, First Treatment for Chronic Hepatitis D
The U.S. Food and Drug Administration has granted approval to Hepcludex (bulevirtide‑gmod), marking the first FDA‑cleared therapy for chronic hepatitis D in adults without cirrhosis or with compensated cirrhosis. Approval follows the phase 3 MYR301 trial, which showed a 48% combined response...
Skape Bio Unlocks Generalizable GPCR Drugs Using AI Protein Design
Skape Bio, founded by former UW protein‑design researcher Chris Norn, has unveiled an AI‑driven platform that creates miniprotein therapeutics for G‑protein‑coupled receptors (GPCRs). A recent Nature paper shows functional miniproteins targeting 11 diverse GPCRs, including agonists validated on three receptors....
Avanzanite Bioscience’s Partner Agios Announces PYRUKYND® (Mitapivat) Approval in the European Union for Adults with Thalassaemia
Avanzanite Bioscience announced that the European Commission has granted marketing authorisation for PYRUKYND® (mitapivat) to treat anaemia in adults with transfusion‑dependent or non‑transfusion‑dependent alpha‑ or beta‑thalassaemia. The approval follows positive CHMP opinion and data from the Phase 3 ENERGIZE and ENERGIZE‑T...
Experimental mRNA Vaccine May Protect Against Multiple Ebola Viruses
Researchers have created an experimental mRNA vaccine that protects rodents from three orthoebolavirus strains, including the Bundibugyo virus driving the current outbreak in the Democratic Republic of the Congo and Uganda. The study shows the vaccine elicits robust antibody responses...
Expanded Label for Efgartigimod Offers Fast-Acting Treatment for gMG: James F. Howard, MD
On May 11, 2026, the FDA broadened the indication for efgartigimod, approving it for all adult patients with generalized myasthenia gravis, including AChR‑positive, MuSK‑positive, LRP4‑positive, and triple‑seronegative subtypes. The decision follows the phase‑3 ADAPT SERON trial, which enrolled 119 patients...
AstraZeneca Wins EU Backing for Breast Cancer Drug, Splitting with FDA Panel
AstraZeneca’s breast‑cancer therapy, identified as [drug], received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, clearing the path for EU approval. In contrast, an FDA advisory committee voted against the drug last month,...
BioMarin's Voxzogo Shows Surprising Growth Boost in Hypochondroplasia Trial
BioMarin announced that its achondroplasia drug Voxzogo increased annualized growth velocity by 2.33 cm per year in a Phase 3 study of children with hypochondroplasia. The result exceeds performance seen in the approved indication and positions the company to file for a...
OSE Immunotherapeutics Reports Positive Phase 2 Data for Tedopi/Keytruda in Recurrent Ovarian Cancer
OSE Immunotherapeutics SA announced that its Phase 2 TEDOVA trial met its primary endpoint, showing the Tedopi‑Keytruda combination extended median progression‑free survival to 4.1 months versus 2.8 months with best supportive care in platinum‑sensitive recurrent ovarian cancer. The addition of Keytruda...
GLP‑1 Cancer Link Unclear, Dedicated Trials Needed
Whether there is a real impact of GLP-1 drugs on cancer is unresolved. If confirmed, it could simply reflect weight loss or, as seen for other conditions (e.g. heart, kidney), weight loss independent effects. We need dedicated trials to resolve...
OSE’s Tedopi-Keytruda Combo Clears Phase II Ovarian Cancer Hurdle
French biotech OSE Immunotherapeutics announced positive Phase II data for its cancer vaccine Tedopi combined with Merck's Keytruda in platinum‑sensitive recurrent ovarian cancer. The combination improved median progression‑free survival to 4.1 months versus 2.8 months with best supportive care, cutting the risk of...
NIH Researchers Identify Avenue for Enhanced GLP-1-Induced Weight Loss
NIH scientists have mapped how the GLP‑1 agonist semaglutide triggers intracellular signaling in mouse hindbrain neurons, pinpointing cyclic AMP (cAMP) elevation in the area postrema as a key driver of weight loss. The study revealed that cAMP responses differ across...
What Is Immunotherapy and How Does It Treat Cancer and Other Conditions?
Immunotherapy research has surged, with clinical trials climbing from 1,257 between 2006‑2016 to 4,591 in the past decade. Cancer treatments dominate the field, featuring checkpoint inhibitors, CAR‑T cells, and mRNA‑based vaccines now approved for more than 30 tumor types. Researchers...
Cognitive Effects Vary by Therapy for Advanced Prostate Cancer
A phase‑2 ARACOG trial presented at ASCO showed that men with advanced prostate cancer receiving darolutamide experienced significantly less cognitive decline over 24 weeks than those on enzalutamide. The study enrolled 111 patients (median age 71) and evaluated five computer‑based neurocognitive tests,...
FDA Clears FoundationOne CDx as Companion Diagnostic for Tepotinib in MET‑Exon‑14 NSCLC
The U.S. FDA approved Foundation Medicine’s FoundationOne CDx test as a companion diagnostic for tepotinib (TEPMETKO) in MET exon‑14‑skipping non‑small cell lung cancer, enabling broader patient identification for the targeted therapy. The clearance leverages real‑world data from over 150,000 patients...
Black Diamond Shares Tumble 6% Despite 15‑month PFS for Silevertinib in 1L NSCLC
Black Diamond Therapeutics saw its shares drop 6.2% to $3.33 after announcing that its Phase 2 trial of Silevertinib delivered a median progression‑free survival of 15.2 months in first‑line EGFR‑non‑classical NSCLC. The market reaction highlights investors’ skepticism that the data will...
Invenra Names Nancy J. Sandy CCO to Drive Global Antibody Platform Growth
Invenra announced the appointment of Nancy J. Sandy as chief commercial officer, giving the Madison‑based biotech its first dedicated commercial leader to accelerate the B‑Body bispecific and T‑Body trispecific antibody platforms worldwide.
NervGen Secures $60 Million in Share‑Warrant Offering to Push NVG‑291 Forward
NervGen Pharma Corp priced a public offering of 24 million common shares and matching warrants at $2.50 per unit, generating roughly $60 million in gross proceeds. The cash will be used to advance the company’s lead candidate NVG‑291 for spinal‑cord injury, while...
The NMPA Grants Conditional Approval to Boehringer Ingelheim’s Hernexeos for 1L HER2-Mutant NSCLC
China's National Medical Products Administration granted conditional approval to Boehringer Ingelheim’s oral HER2‑mutant NSCLC drug Hernexeos (zongertinib). The decision is based on a Phase Ib trial of 74 treatment‑naïve patients that delivered a 75.7% overall response rate and a median...
Astellas Receives CHMP Positive Opinion for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Astellas’ Padcev (enfortumab vedotin) combined with Keytruda (pembrolizumab) for neoadjuvant and adjuvant treatment of cisplatin‑ineligible patients with resectable muscle‑invasive bladder cancer (MIBC). The...
Biogen, Denali to Drop Drug in Non-Genetic Parkinson’s After Mid-Stage Study Flop
Biogen and Denali Therapeutics announced that their LRRK2 inhibitor BIIB122 failed to meet primary endpoints in a Phase 2b trial of early‑stage Parkinson’s disease. The mid‑stage study, which targeted patients without the LRRK2 genetic mutation, showed no statistically significant slowing...
AI‑Designed Miniproteins Toggle GPCRs, Matching Drugs in Mice
Scientists at the University of Washington’s Institute for Protein Design and biotech Skape Bio used artificial intelligence to engineer miniproteins that can activate or block G protein‑coupled receptors. In mouse experiments the engineered proteins performed on par with an approved...
Eli Lilly’s Retatrutide Delivers up to 28% Weight Loss in Phase 3 Trial
Eli Lilly announced that its experimental triple‑agonist retatrutide achieved up to 28.3% weight loss (about 70 lb) over 80 weeks in a pivotal Phase 3 trial, with 45% of participants shedding 30% or more. The data positions the drug as a potential game‑changer...
Biogen, Denali Pull BIIB122 After Phase 2b LUMA Fails to Slow Parkinson's
Biogen and Denali Therapeutics announced they are halting development of BIIB122, a LRRK2 inhibitor for Parkinson's disease, after the Phase 2b LUMA trial failed to meet its primary and secondary endpoints. The setback removes a key candidate from both companies'...
Cyclarity Therapeutics Reports Safety Data for 7-Ketocholesterol Clearance
Cyclarity Therapeutics reported first clinical evidence that its AI‑engineered cyclodextrin drug, UDP‑003, can safely bind and promote urinary excretion of 7‑ketocholesterol, a toxic oxysterol linked to atherosclerosis. The Phase 1 safety trial demonstrated favorable pharmacokinetics and pharmacodynamics, with no serious adverse...
Akari Therapeutics Shares Double on KRAS Synergy Data, Raises $5.5M for ADC Trial
Akari Therapeutics' shares surged more than 100% in pre‑market trading after the company disclosed preclinical data that its lead ADC, AKTX-101, works synergistically with KRAS inhibitor Adagrasib in pancreatic cancer models. The biotech also priced a $5.5 million private placement to...
Retatrutide Results Suggest a Change in the Order of Things
Eli Lilly’s phase‑3 trial of retatrutide, a triple‑agonist peptide, showed patients with severe obesity lost an average of 30% of body weight over 80 weeks, a result comparable to bariatric surgery. The study also reported significant improvements in cardiometabolic markers such...
Does FDA's Shift From Two Pivotal Trials to One Represent a Genuine Evolution?
The FDA is increasingly willing to approve drugs based on a single pivotal trial, a shift described by former FDA Oncology Division Director Harpreet Singh as an evolution rather than a revolution. In oncology, especially for rare, life‑threatening cancers, a...
NICE Changes Stance on Genmab's Cervical Cancer Drug
Two months after rejecting Genmab’s Tivdak, the UK health technology body NICE has reversed course, recommending the antibody‑drug conjugate for adults with recurrent or metastatic cervical cancer. The decision follows a revised economic model that incorporates the innovaTV 301 trial results...
Allergan Aesthetics (AbbVie) Reports CHMP Positive Opinion for Boey to Temporarily Improve Glabellar Lines in Adults
Allergan Aesthetics, a unit of AbbVie, received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending Boey (trenibotulinumtoxinE) for the temporary improvement of moderate-to-severe glabellar lines in adults. The recommendation covers all...
The Problem at the Heart of Drug Discovery: Lexogen & Ochre Bio on the Power of AI on Human Data
Lexogen, an RNA transcriptomics and NGS service provider, teamed up with Ochre Bio, a biotech developing AI‑driven RNA therapies for chronic liver disease. The partnership leverages Lexogen’s high‑throughput sequencing to generate human‑first data that trains Ochre’s predictive models. Together they...
Biogen, Denali Pull Parkinson's Drug After Failed Trial
Biogen has halted development of BIIB122, its LRRK2‑inhibitor partner with Denali, after the phase 2b LUMA trial failed to slow Parkinson’s disease progression despite achieving about 30% target inhibition. The study, which included both LRRK2‑mutated and idiopathic patients, missed its primary...
BMS Deploys Anthropic’s Claude AI Across Global Drug‑Discovery Operations
Bristol‑Myers Squibb announced a strategic partnership with Anthropic to embed the Claude foundation model into every major function of its global business, covering more than 30,000 employees. The move is billed as a way to break data silos and accelerate...