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.
TrivarX Engages Beyond Drug Development to Progress Stabl-Im Safety Trial
TrivarX announced a partnership with specialist CRO Beyond Drug Development to drive the Phase 1 safety trial of its Stabl‑Im oncology imaging platform. Beyond will handle protocol finalisation, regulatory documentation and site selection as TrivarX prepares to dose healthy volunteers in an open‑label, sequential‑cohort study slated for the second half of 2026. Stabl‑Im is an MRI‑based functional imaging technology that visualises proliferating tumour cells using stable isotopes, eliminating the need for radioactive tracers. The trial’s outcome will set the stage for Phase 2 efficacy work and broader commercialisation plans.
Lilly's Retatrutide Shows Early Muscle‑Sparing Weight‑Loss Results
Eli Lilly’s experimental obesity drug retatrutide has produced early trial data indicating up to 33% body‑weight loss with a measurable muscle‑preserving effect. Neuroscientist Andrew Huberman highlighted the drug’s triple‑agonist mechanism and warned against unregulated gray‑market sources.
Oculis Wins FDA Special Protocol Assessment for Phase 3 Privosegtor Trial
Oculis Holding (NasdaqGM:OCS) secured a U.S. Food and Drug Administration Special Protocol Assessment (SPA) for the Phase 3 PIONEER‑1 trial of Privosegtor, its neuro‑ophthalmic therapy for optic neuritis. The agreement confirms FDA acceptance of the trial design, reducing regulatory uncertainty for...
Eli Lilly’s Retatrutide Cuts Average Body Weight 28% in Pivotal Phase 3 Trial
Eli Lilly announced that its experimental triple‑agonist retatrutide delivered an average 28.3% (≈70 lb) weight loss in the pivotal TRIUMPH‑1 Phase 3 trial, with 45.3% of participants shedding at least 30% of their body weight. The result positions the drug alongside bariatric...
STAT+: Closely Watched Experimental Parkinson’s Drug Fails Key Clinical Trial
Biogen and Denali Therapeutics announced that their experimental Parkinson’s drug, a small‑molecule inhibitor of the LRRK2 protein, failed to slow disease progression in a randomized Phase 2 trial. The study enrolled 648 adults who received either the LRRK2 pill or...
Zentalis Pharmaceuticals to Present Phase 1b MUIR Trial Data Showing Encouraging Clinical Activity and Manageable Safety Profile of Azenosertib Plus...
Zentalis Pharmaceuticals will present Phase 1b MUIR trial results showing that the WEE1 inhibitor azenosertib combined with paclitaxel yields a 39% overall response rate and a median progression‑free survival of 7.3 months in heavily pre‑treated platinum‑resistant ovarian cancer (PROC) patients. The data,...
#ASCO26: Key Head and Neck Cancer Readouts From J&J, Corbus, Summit, Akero and Bicara
At ASCO 2026, Johnson & Johnson, Corbus, Summit, Akero and Bicara unveiled pivotal data on next‑generation therapies for head and neck squamous cell carcinoma. J&J’s pembrolizumab‑plus‑chemotherapy regimen reduced the risk of death by roughly 20% in first‑line patients. Corbus reported...
#ASCO26: New Data Released for VEGF Bispecifics From BioNTech-BMS, Pfizer-3SBio
At ASCO 2026, BioNTech‑BMS and Pfizer‑3SBio unveiled new Phase 1/2 data on their VEGF‑targeting bispecific antibodies. BioNTech‑BMS reported a 45% overall response rate in heavily pre‑treated solid‑tumor patients, while Pfizer‑3SBio’s candidate achieved disease control in 78% of a similar cohort....
STAT+: Merck-Kelun Lung Cancer Drug Cut Risk of Tumor Progression by 65%, ASCO Abstract Shows
Merck and China‑based Kelun‑Biotech announced that their antibody‑drug conjugate sacituzumab tirumotecan (sac‑TMT) reduced the risk of tumor progression by 65% in a Phase 3 trial of untreated advanced non‑small cell lung cancer (NSCLC). The study, conducted in China, also showed an...
CVS Health Sued Over Alleged Scheme to Siphon 340B Drug Program Savings
Three major hospital systems sued CVS Health and its affiliates, alleging the company diverted roughly $250 million in savings from the federal 340B Drug Pricing Program between 2020 and 2025. The lawsuits claim CVS Specialty and its PBM unit paid hospitals...
Hutchmed, Innovent Win Chinese Approval for Fruquintinib‑Sintilimab Combo in Kidney Cancer
Hutchmed (China) Limited and Innovent Biologics announced that China’s National Medical Products Administration has approved ELUNATE (fruquintinib) combined with TYVYT (sintilimab) for patients with locally advanced or metastatic renal cell carcinoma who have exhausted prior VEGFR‑TKI therapy. The decision follows...
Eli Lilly’s Triple Combo Obesity Drug Tops 28% Weight Loss in a Pivotal Trial
Eli Lilly’s experimental obesity drug retatrutide delivered an average 28.3% weight loss – roughly 70 pounds – in its Phase 3 trial, with the highest dose leading the result. The study enrolled 2,339 participants without diabetes and tested three escalating doses, each outperforming...
Eli Lilly Buys Engage Bio for $202M, Adding Non‑Viral DNA Delivery Platform
Eli Lilly agreed to acquire Engage Bio for up to $202 million in cash, securing the startup’s preclinical non‑viral DNA delivery platform, Tethosome. The deal marks Lilly’s seventh acquisition of 2026 and deepens its push into genetic medicines beyond its blockbuster...
Cytokine‑Armored CAR T Cells Overcome Antigen Heterogeneity in Glioma Model
UCLA researchers have engineered cytokine‑armored CAR‑T cells that secrete IL‑12 and a decoy‑resistant form of IL‑18 (DR‑18) to treat glioblastoma in mouse models. The IL‑12/DR‑18 combination enabled CAR‑T cells to eradicate tumors even when cancer cells lacked the targeted IL‑13Rα2...
New Eye Drop Formulation Shows Promise for Dry Eye Disease
Researchers at Baylor College of Medicine and Okayama University have created a water‑soluble rexinoid eye‑drop, NEt‑3IB, that boosts resident macrophage function and mitigates dry‑eye pathology in mouse models. The formulation significantly lowered ocular inflammation, preserved corneal barrier integrity and goblet...
Vitamin B12 Analog Targets Deadly Brain Cancer Cells
Researchers at Nitric Oxide Services and Cleveland Clinic have demonstrated that nitrosylcobalamin, a nitric‑oxide‑releasing vitamin B12 analog, can penetrate the blood‑brain barrier and preferentially accumulate in glioblastoma tissue in rat models. Pharmacokinetic data show sustained tumor nitrate levels for at...
Targeting Tumor-Specific Inflammatory Process May Prevent Drug Resistance in Colon Cancer
A preclinical study from Weill Cornell Medicine and MD Anderson reveals that colorectal tumors with KRAS mutations develop resistance to KRAS inhibitors primarily through a tumor‑specific inflammatory response rather than additional KRAS mutations. The researchers observed early up‑regulation of inflammatory...
Wegovy Shows 22% Average Weight Loss and Cardiovascular Gains for Menopausal Women
Novo Nordisk announced that Wegovy (semaglutide) produced an average 22.6% weight loss in premenopausal women and roughly 20% loss in perimenopausal and postmenopausal groups, while also cutting heart attack, stroke, migraine and depression risks. The findings were unveiled at the...
MaaT Pharma Requests EMA Re‑examination After CHMP Issues Negative Trend Opinion on Xervyteg
MaaT Pharma announced it will request a re‑examination of its marketing authorization for Xervyteg (MaaT013) after the EMA’s CHMP issued a negative trend opinion. The formal CHMP vote is slated for June 2026, and the company says it remains committed...
Peanut OIT Safety in Preschoolers: A Slow-Dosing Strategy
A new randomized controlled trial in The Lancet shows that a slow up‑dosing schedule combined with a low maintenance dose makes peanut oral immunotherapy (OIT) safer for preschool‑aged children. The study enrolled roughly 150 participants aged 12‑48 months and found...
Regenxbio’s RGX-202 Gene Therapy Hits Primary Endpoint in Phase 3 Duchenne Trial
Regenxbio announced that its RGX-202 gene therapy met the primary endpoint in the Phase 3 portion of the AFFINITY DUCHENNE trial, with 93% of participants reaching at least 10% microdystrophin expression. The data support an accelerated FDA filing and set...
Financings for May 21, 2026
BioWorld reported three major developments on May 21, 2026. Researchers unveiled a “detargeted” gene‑therapy platform that enhances enzyme activity and reduces off‑target effects for Pompe disease. The World Health Organization declared the Ebola outbreak in the Democratic Republic of Congo a public‑health...
BioMarin Notches Win in Study that Could Expand Use of Top-Selling Medicine
BioMarin announced positive Phase 3 data showing its blockbuster drug Voxzogo accelerates growth in children with hypochondroplasia, a milder form of dwarfism. The trial reported significant gains in standing height and arm span after one year versus placebo. Analysts estimate the...
The Multiple Myeloma Revolution Happening Right Now: Swarup Kumar, MD
Swarup Kumar, MD highlights that bispecific antibodies are driving multiple myeloma cure rates up to 30‑40%, a stark rise from the historic sub‑10% figure. He notes that real‑world outcomes, while promising, still trail slightly behind trial data, underscoring the need...
Scribe Therapeutics Achieves Regulatory Clearance to Initiate First-in-Human Clinical Study of STX-1150 for LDL-C Reduction
Scribe Therapeutics received clearance from Australia’s TGA to start a first‑in‑human Phase 1 study of STX‑1150, an in‑vivo CRISPR‑based therapy that epigenetically silences PCSK9 to lower LDL‑C. The open‑label, single‑ascending‑dose trial will enroll up to 64 high‑risk hypercholesterolemia patients across Australia...
Merck Announces First Patient Dosed in Phase 3 Study for Investigational Antibody-Drug Conjugate in Colorectal Cancer
Merck has dosed the first patient in the Phase 3 PROCEADE‑CRC‑03 trial of Precem‑TcT, the company’s inaugural anti‑CEACAM5 antibody‑drug conjugate (ADC) featuring an exatecan payload for metastatic colorectal cancer (mCRC). In Phase 1, the ADC achieved a 20.7% confirmed objective response rate...
ASCO 2026: Bayer to Present New Data Across Oncology Portfolio
Bayer announced that it will unveil 16 new oncology abstracts at the ASCO 2026 meeting in Chicago, spanning prostate, breast, lung, renal‑cell, colorectal and salivary‑gland cancers. The headline presentation will feature Phase II head‑to‑head data comparing NUBEQA (darolutamide) with enzalutamide in...
Degrader–Antibody Conjugates: Can Targeted Delivery Improve Tolerability?
Degrader‑antibody conjugates (DACs) fuse small‑molecule protein degraders to targeting antibodies, aiming to deliver the degrader selectively to disease‑relevant cells. Early pre‑clinical studies show that DACs can achieve potent target knock‑down while sparing healthy tissue, translating into a markedly better safety...
Fixing Medication Adherence In Clinical Trials: How Technology Stops Data Corruption
Medication adherence in clinical trials is notoriously difficult to measure, with self‑reports often exceeding 90% while biomarker data reveal far lower rates. Traditional methods such as dosing diaries and pill counts are vulnerable to patient error and intentional manipulation, compromising...
Avaí Bio, Austrianova Advance Α-Klotho Cell Therapy Manufacturing Step
Avaí Bio and Austrianova have finished a GMP‑compliant master cell bank (MCB) of genetically engineered cells that overexpress the anti‑aging protein α‑Klotho. The bank will now undergo independent viral and adventitious‑agent testing before a working cell bank is created for...
Study Finds GLP‑1 Drugs Cut ‘Food Noise,’ Boosting Weight‑Loss Success
Researchers presented data at the European Congress on Obesity indicating that GLP‑1 drugs such as Ozempic, Wegovy and Mounjaro significantly reduce “food noise,” a metric of intrusive food cravings. In a month‑long digital weight‑management trial of 417 adults, participants on...
ImmunityBio’s ANKTIVA + BCG Gets FDA Supplemental BLA Acceptance, Decision Set for Jan 6 2027
ImmunityBio announced that the FDA has accepted its supplemental biologics license application to expand ANKTIVA + BCG into BCG‑unresponsive non‑muscle invasive bladder cancer with papillary disease only. The agency set a PDUFA target action date of Jan. 6 2027, and the filing is backed...
How Eli Lilly's Next-Gen Obesity Drug Is 'Raising The Bar' In Weight Loss
Eli Lilly’s next‑generation obesity drug retatrutide delivered dramatic weight loss in the Phase 2 Triumph‑1 trial, with participants shedding an average 28.3% of body weight (about 70 lb) after 80 weeks and up to 30.3% (≈85 lb) in a 104‑week extension. Nearly half of...
Label Change Helps Remove Barriers to Broader Use of Epcoritamab in DLBCL, Sharman Says
The FDA revised the label for epcoritamab (Epkinly) on April 1, 2026, allowing the first full 48‑mg dose to be administered in an outpatient setting for relapsed/refractory diffuse large B‑cell lymphoma (DLBCL). The change follows interim data from the EPCORE NHL‑6 study,...
Bayer Secures FDA Priority Review for Kerendia in Type 1 Diabetes‑Related Kidney Disease
Bayer AG announced that the U.S. FDA has granted priority review to its supplemental New Drug Application for Kerendia in adults with type 1 diabetes and chronic kidney disease. The decision follows positive Phase III FINE‑ONE data showing a significant reduction in...
M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)
The ICH has issued the M11 Template — Clinical Electronic Structured Harmonised Protocol (CeSHarP) – a draft guidance released in June 2025. The template standardizes the format, table of contents, and common headers for clinical trial protocols, while the accompanying Technical Specification defines...
Eli Lilly Reports P-III (TRIUMPH-1) Trial Data on Retatrutide for Weight Management
Eli Lilly’s phase‑III TRIUMPH‑1 trial showed its triple‑agonist retatrutide produced dramatic weight loss in adults with obesity and at least one weight‑related comorbidity. Across 80‑week endpoints, the 12 mg dose cut mean body weight by 28.3% and waist circumference by 24.1 cm, with...
Retatrutide Delivers up to 30% Weight Loss in Phase 3 Trials
Retatrutide just delivered some very impressive phase3 results for $LLY at 4mg, 9mg and 12mg -- https://t.co/7sKbaDoInq Retatrutide is their GLP-3 ie triple agonist which hits the GLP, GIP and Glucagon receptors. At the primary endpoint of 80 weeks... patients on 4mg,...
20 Phase‑3 Trials Poised to Redefine Cancer Care
In the wake of the #ASCO26 data drop, we reflect on 20 key phase 3 trials which could make a significant impact. Some of these may make their competitors irrelevant if they change the standard of care: https://t.co/EGtw35EsSk https://t.co/CG0Oe4QxDg
Infex Chases After Insmed with Bronchiectasis Trial Win
Infex Therapeutics announced that its anti‑PcrV antibody RESP‑X (INFEX702) successfully completed a Phase 2a trial in patients with non‑cystic fibrosis bronchiectasis (NCFB) colonised by Pseudomonas aeruginosa. The study demonstrated early efficacy signals, a favorable safety profile and a 28.8‑day half‑life supporting...
Genomics Predict Venetoclax Response in T(
Genomic Determinants of Clinical Outcomes in Multiple Myeloma with t(11;14)(CCND1;IGH) Treated with Venetoclax [Dec 7, 2024] @MKaddouraMD et al. @lbaughn #ASH24 Abst 249 https://t.co/TLon5bCQ3i #mmsm #PrecisionMedicine
New Trial Compares Dara‑Bor‑Dex vs Cy‑Bor‑Dex for Myeloma‑Induced Kidney
EAA241 - Ph 2 RCT Dara-Bor-Dex vs Cy-Bor-Dex in the treatment of Newly Diagnosed Multiple Myeloma with Light Chain Cast Nephropathy (LCCN) [Study activated 8/11/25] @keruakous https://t.co/1NgvVZ3fTA #NCT07085728 #mmsm @eaonc
Intellia Files First CRISPR‑Based BLA, Testing FDA’s New Post‑Approval Guidance
Intellia Therapeutics has filed a biologics license application for its in‑vivo CRISPR therapy targeting transthyretin amyloidosis, becoming the first CRISPR‑based product to be reviewed under the FDA’s September 2024 draft guidance on post‑approval monitoring. The move pits the company against...
Incyte Leverages AI Partnerships to Accelerate Future R&D
35-year-old Incyte is turning to AI to power through the coming decades, with new R&D deals with Edison Scientific & Genesis Molecular AI: https://t.co/5rinB9m8m4
Retatrutide Delivers Record 28% Weight Loss, Raises Safety Concerns
Retatrutide, a triple receptor drug for GLP-1, GIP, and glucagon, is the most powerful weight loss drug yet. A significant issue is too much weight loss among the trial participants. New randomized trial results announced today with 28% body weight...
AIM ImmunoTech Secures $2.4 Million via Direct Share Offering and Warrant Placement
AIM ImmunoTech Inc. entered definitive agreements for a registered direct offering of 7.51 million shares at $0.325 per share, targeting roughly $2.4 million in gross proceeds. A concurrent private placement of Series I warrants for up to 15.04 million shares will also raise capital,...
What Does the Regulatory Landscape Look Like From the Other Side of FDA?
Harpreet Singh, MD, former FDA Oncology Division Director and now chief medical officer at Precision for Medicine, explains that industry sponsors find the oncology regulatory landscape more navigable when they leverage insider experience. He stresses three pillars: early and frequent...
Bayer Gets Swift Review for Kerendia in Type 1 Diabetes
Bayer has applied to the FDA for a label extension of its mineralocorticoid receptor antagonist Kerendia to treat chronic kidney disease in type 1 diabetes patients. The agency granted priority review, promising a decision within six months. Phase 3 FINE‑ONE data showed...
ATS 2026: Long-Term Data Show Durable Benefit of Trikafta for Cystic Fibrosis
At the 2026 American Thoracic Society conference, a German single‑centre cohort of 106 adults with cystic fibrosis and at least one F508del allele reported four‑year outcomes on Trikafta (elexacaftor/tezacaftor/ivacaftor). Patients showed a 0.5 L (15.6%) rise in FEV1, a 28.9% drop...
Quality by Design: The Impact of Disconnected Systems on Clinical Data
Clinical trials are increasingly digital, but the rapid addition of tools like EDC, ePRO, safety databases, CTMS, eTMF and RBQM often results in fragmented, poorly integrated systems. These disconnections force duplicate data entry, create inconsistent audit trails, and raise the...