Celcuity Reports the P-III (VIKTORIA-1) Trial Data on Gedatolisib Combination for HR+/HER2- PIK3CA Mutant Advanced Breast Cancer
Celcuity presented Phase III VIKTORIA‑1 results showing that gedatolisib combined with fulvestrant, with or without palbociclib, markedly outperformed standard of care in HR+/HER2‑negative advanced breast cancer patients harboring PIK3CA mutations. The triplet regimen achieved a median progression‑free survival (mPFS) of 11.1 months versus 5.6 months, an objective response rate (ORR) of 48.9% versus 26%, and a median duration of response (mDOR) of 15.7 months versus 7.5 months. The doublet also delivered an mPFS of 11.3 months and a 35.7% ORR, with early overall‑survival signals trending positively. Celcuity plans to submit a supplemental NDA to the FDA, while the agency reviews a separate NDA for gedatolisib in PIK3CA‑wild‑type disease.
Chinese Team Transplants Pig Liver and Kidneys Into Brain‑Dead Patient, Organs Function 36 Hours
Researchers at Guangxi Medical University in Nanning transplanted a genetically edited pig liver and two kidneys into a 53‑year‑old brain‑dead donor, achieving normal organ function for 36 hours before early immune rejection appeared. The breakthrough demonstrates that multi‑organ xenotransplantation is...
Lilly, Ascidian Link up in RNA Exon Editing Pact
Eli Lilly has signed a research collaboration with Ascidian Therapeutics that could total up to $1.9 billion, including upfront cash, milestone payments and royalties. The partnership will apply Ascidian’s RNA exon‑editing platform, which swaps damaged RNA segments without altering DNA, to genetically...
Esterified IPA with Curcumin Shields Neurons From Glucose Damage
Researchers reported that an esterified indole‑3‑propionic acid (IPA)‑curcumin compound protects neurons from high‑glucose‑induced damage. The molecule restores Akt/mTOR signaling, up‑regulates BDNF/TrkB activity, and markedly lowers oxidative stress in cell cultures. In hyperglycemic rodents, the treatment improves memory performance and preserves...
Lupin and Natco Win FDA Nod for Generic Eribulin, Target $44M US Market
Lupin Limited and its partner Natco Pharma have secured U.S. FDA approval for a generic eribulin mesylate injection, a bioequivalent to Eisai's Halaven. The approval opens a $43.7 million annual U.S. market for metastatic breast cancer and liposarcoma therapies and promises...
Why Tumors Resist Immunotherapy: How Removing Their Armor Can Turn Cold Cancers Hot
Researchers at UC San Diego identified microRNA‑25 (miR‑25) as a key driver of resistance to immune checkpoint therapy. Deleting miR‑25 in mouse melanoma, colon and breast cancer models did not affect tumor growth alone but markedly improved response to checkpoint...
Revolution Medicines' Daraxonrasib Doubles Pancreatic Cancer Survival in Phase 3 Trial
Revolution Medicines presented Phase 3 data showing its KRAS‑targeted pill daraxonrasib doubled median overall survival for metastatic pancreatic cancer patients to 13.2 months, versus 6.7 months on chemotherapy. The results earned a standing ovation at the ASCO 2026 meeting and...
Gilead's Livdelzi Posts Positive Phase 3 Results, Lifting PBC Outlook
Gilead Sciences announced that its investigational drug Livdelzi (seladelpar) met primary and key secondary endpoints in the Phase 3 IDEAL trial for primary biliary cholangitis (PBC). The news sent GILD shares higher and positioned the company for a potential new...
NewLimit Secures $435 Million Series C to Fast‑Track Cell‑Rejuvenation Therapy
Anti‑aging biotech NewLimit closed a $435 million Series C round, led by Founders Fund and joined by Kleiner Perkins, Eli Lilly Ventures and others. The capital will fund a Phase 1 trial of its liver‑rejuvenation candidate and broaden its pipeline into kidney...
Contraline Secures $92.5m to Push Male Contraceptive Into Late-Stage Trials
Contraline closed a $92.5 million Series B round led by RA Capital and BVF Partners to advance its topical, reversible male contraceptive NES/T Gel into Phase III trials. The gel, which pairs the progestin Nestorone with testosterone, showed efficacy, tolerability and reversibility in...
Spatial Single‑Cell Platform Reveals Barriers to Antibody Delivery in Solid Tumors
Researchers at Vanderbilt and Stanford unveiled a single‑cell spatial pharmacology (SSP) platform that maps therapeutic antibody delivery inside human solid tumors. Published in Nature Biotechnology, the system visualizes drug distribution, target engagement, and the physical barriers that impede efficacy. Applying...
Dense Tumor Stroma Causes Highly Uneven Antibody Delivery
A single-cell platform tracked an antibody drug through pancreatic and head and neck tumors and showed sharply uneven delivery from one region to another. Dense surrounding tissue appeared to block access in parts of the tumor. cancerbiology
Genetically Modified Hookworms Produce and Deliver Therapeutics
Washington University researchers have genetically engineered the human hookworm to produce a therapeutic antibody that neutralizes tetrodotoxin. In animal studies, the modified worms colonized the gut, secreted the anti‑toxin protein into the bloodstream, and partially inactivated the toxin. The proof‑of‑concept...
Oncolytics Biotech Reports Initial Preclinical Data of Pelareorep with RAS Inhibitors
Oncolytics Biotech disclosed early preclinical results showing that pelareorep, a systemic oncolytic virus, combined with RAS‑targeted inhibitors delivers stronger anti‑tumor activity than either agent alone in solid‑tumor models. The company will extend the combination testing to pancreatic ductal adenocarcinoma and...
Differential Effects of PD-1 and PD-L1 Immune Checkpoint Inhibition on Cognition and Anxiety-Like Behavior Through ΓδT Cells and Tumor–Dependent Neuroinflammation
A new preprint examines how anti‑PD‑1 and anti‑PD‑L1 checkpoint inhibitors affect cognition and anxiety in mice bearing different tumor immune phenotypes. Immuno‑excluded and immuno‑inflamed cancers impair short‑term memory and provoke anxiety‑like behavior, with the latter showing heightened IL‑6/IL‑17 inflammation and...
AstraZeneca Highlights P-III (SERENA-6) Trial Data on Camizestrant Combination for ESR1 Mutated Advanced Breast Cancer at ASCO’26
AstraZeneca presented Phase III SERENA‑6 data showing that camizestrant combined with a CDK4/6 inhibitor markedly outperformed an aromatase‑inhibitor (AI) backbone in 315 patients with ESR1‑mutated, HR‑positive/HER2‑negative advanced breast cancer. The camizestrant arm achieved a median progression‑free survival (PFS) of 16.8 months versus...
Gilead Reports the P-III (IDEAL) Trial Data on Livdelzi (Seladelpar) in Primary Biliary Cholangitis (PBC)
Gilead disclosed Phase III IDEAL trial results for Livdelzi (seladelpar) in 96 primary biliary cholangitis (PBC) patients who were inadequately controlled on or intolerant to ursodeoxycholic acid. The study showed a statistically significant higher rate of alkaline phosphatase (ALP) normalization after...
Concord Biotech Jumps 8% on USFDA Nod for Mycophenolate Mofetil Oral Suspension
Concord Biotech announced US FDA approval of its Mycophenolate Mofetil oral suspension (200 mg/mL), an immunosuppressant for kidney, heart and liver transplant patients. The clearance opens a U.S. market opportunity estimated at $30 million and aligns with the company’s growth plan. Shares...
Combination Therapy Sustains 49% Melanoma Reduction After 5 Years
A phase 2b KEYNOTE‑942 trial presented at ASCO 2026 shows that a personalized mRNA melanoma vaccine (intismeran autogene) combined with Merck’s Keytruda dramatically improves outcomes. Five‑year overall survival reached 92.2% versus 71.3% with Keytruda alone, and the risk of distant metastasis...
New Study Shows How mRNA Vaccines Could Transform Cancer Treatment
A new study in the Journal of Clinical Oncology reports that adding a personalized mRNA vaccine to standard immunotherapy raised the five‑year melanoma‑free survival rate to nearly 70%, versus 49% with immunotherapy alone. Overall five‑year survival climbed to 92% for...
Legend Biotech (LEGN) Soars 42% on Promising Cancer Therapy Results
Legend Biotech (NASDAQ:LEGN) saw its stock surge 42% to $36.28 after reporting Phase 1 data for its in‑vivo CAR‑T candidate LB2501. The trial enrolled six patients with relapsed/refractory B‑cell non‑Hodgkin lymphoma, all of whom responded, and five achieved complete remission with...
Rice University Unveils Programmable Blood Test to Track Brain Gene Activity in Real Time
A Rice University bioengineering team announced a programmable blood test that can noninvasively monitor transcription of specific brain genes. Published in Nature Communications, the INTACT platform demonstrated real‑time tracking of three brain regions in animal models, promising a new diagnostic...
Biotech Leaders REPL, SNSE, C4 Therapeutics, and IMRX Top Weekly Gainers on Clinical Milestones
Replimune (REPL) jumped after announcing a resubmission of its RP1 biologics license application for advanced melanoma. Sensei Biotherapeutics (SNSE) and C4 Therapeutics (CCCC) rose on upcoming Phase 2 data and a June 12 clinical update, while ImmuneRx (IMRX) posted the...
3PBIOVIAN Expands Its Mammalian Capacity with an Additional 2,000 L Bioreactor
3PBIOVIAN has installed a 2,000‑liter single‑use bioreactor, expanding its mammalian cell‑culture capacity from 50 L up to large‑scale GMP production. The addition completes a continuum of volumes that supports process development, analytical control, and batch release under one platform. By integrating...
Immunotherapy Added to Radiation Therapy Boosts Survival in Localized Prostate Cancer
A phase‑3, double‑blind trial of 745 men with intermediate‑ or high‑risk localized prostate cancer showed that adding the adenoviral immunotherapy aglatimagene besadenovec (CAN‑2409) to standard radiation therapy significantly improved disease‑free survival. Only 23% of patients receiving aglatimagene experienced progression, recurrence...
Cross-Reactive T Cells Could Point to Broad Vaccines or Treatments for Measles, Nipah Virus
Scientists at the La Jolla Institute for Immunology have mapped CD4+ T‑cell epitopes for both measles and Nipah viruses, uncovering conserved regions that trigger cross‑reactive T‑cell responses. Blood samples from individuals vaccinated with MMR showed T cells that recognized Nipah...
Eli Lilly's Retatrutide Shows 28.3% Weight Loss in Phase 3 Trial
Eli Lilly reported that its next‑generation obesity drug retatrutide produced an average 28.3% weight loss over 80 weeks in the pivotal TRIUMPH‑1 Phase 3 trial. The result, which rivals bariatric‑surgery outcomes, positions the drug as a potential game‑changer in metabolic biohacking...
Genomics Launches Mystra AI Platform to Boost Drug Target Success
Genomics announced the launch of Mystra AI, a conversational platform built on the largest human genotype‑phenotype database. The tool promises to raise the odds of drug‑target success by 2.6 times, addressing a 95% failure rate in clinical trials.
Inventiva Halts Paris Trading Ahead of Financing Deal, Nasdaq Debut Expected
Inventiva S.A. (IVA) asked Euronext Paris to suspend trading of its ordinary shares at market open on June 2, 2026, pending a pending financing transaction. The halt is slated to end around 3:30 p.m. CEST (9:30 a.m. ET) when the company expects...
CorrectSequence Reports 15‑Month VOC‑Free Results for Base‑Edited Sickle‑Cell Therapy CS‑206
CorrectSequence Therapeutics announced that its transformer base‑editing therapy CS‑206 has kept a 21‑year‑old Nigerian sickle‑cell patient free of vaso‑occlusive crises for more than 15 months after treatment in China, demonstrating durable efficacy and a clean safety profile. The data, released...
Fulcrum Therapeutics Halts Pociredir Sickle‑Cell Program, Shares Dive 51% Amid FDA Concerns
Fulcrum Therapeutics announced the termination of its lead oral EED inhibitor Pociredir for sickle‑cell disease after the FDA raised benefit‑risk concerns linked to secondary malignancies seen with a similar PRC2‑targeting drug. The news sent the company’s shares tumbling 51.25% to...
Irradiation May Help CAR-T Cell Therapy Work Better Against Solid Tumors
Researchers at Icahn School of Medicine discovered that focused irradiation can boost CAR‑T cell therapy against solid tumors. In mouse models of lung cancer and melanoma, a single 8 Gy dose prompted dendritic cells to “dress” themselves with tumor antigens, sustaining...
Basel Innovation Park Main Campus Expands Flexible Infrastructure for Biopharma Startups and Manufacturing
Switzerland Innovation Park’s Basel Main Campus has unveiled a flexible, GMP‑ready laboratory and pre‑production infrastructure aimed at biopharma startups and scale‑up manufacturers. The modular facilities, backed by multi‑million‑dollar investments, allow companies to conduct early‑stage research, test manufacturing processes, and generate...
STAT+: Longevity Startup NewLimit Raises $435 Million Ahead of First Clinical Trial
Longevity biotech NewLimit announced a $435 million Series C round, pushing its valuation to roughly $3.1 billion. The funding, led by Founders Fund and joined by Thrive Capital and Lilly Ventures, backs the company’s first clinical trial of a liver‑targeted therapy slated for...
Immuneering Shares Plunge 22% After Phase 2a Pancreatic Cancer Data
Immuneering Corporation reported Phase 2a efficacy data for atebimetinib combined with modified gemcitabine nab‑paclitaxel in first‑line metastatic pancreatic ductal adenocarcinoma at the 2026 ASCO meeting. The announcement triggered a more than 22% drop in the company’s stock, underscoring the tension...
Turn Therapeutics' GX-03 Shows 92% EASI‑50 Response in Interim Phase 2 Data, Shares Jump Over 20%
Turn Therapeutics announced that 92.6% of participants in its Phase 2 GX-03 trial achieved at least a 50% reduction in eczema severity within four weeks, prompting a stock surge of over 20%. The data, drawn from a 50‑patient interim analysis, positions...
3D-Printed ‘Bones’ Closely Mimic the Real Deal
Researchers at Tampere University have engineered a ceramic 3D‑printed implant made from hydroxyapatite—the mineral that composes natural bone. By precisely controlling pore size (≈400 µm) and porosity (≈45%), the scaffold supports cell infiltration while retaining mechanical strength. The technology, developed under...
Praxis Precision Medicines Reports Phase 2/3 POWER1 Data on Vormatrigine; Primary Endpoint Missed
Praxis Precision Medicines announced topline results from its Phase 2/3 POWER1 trial of vormatrigine in adults with focal onset seizures. The study failed to meet its primary endpoint of percent change in monthly seizure frequency, though it achieved the secondary...
Dog Cancer Research Unlocks Human Oncology Breakthroughs
I'm convinced the path to accelerating human healthcare isn't going to China instead of the US. It's transforming Veterinary Cancer care FIRST. 85% of dog bladder cancers carry a mutation called BRAF V595E. It is the exact ortholog of BRAF V600E in...
Milsaperidone
Milsaperidone (Bysanti®) received FDA approval in February 2026 for adult schizophrenia and for acute manic or mixed episodes of bipolar I disorder. The drug is a triple antagonist of D2R, 5‑HT2AR and α1AR and is a metabolite of the earlier antipsychotic iloperidone....
STAT+: Radiopharmaceutical Shows Promise in Post-Pluvicto Setting
Vera Therapeutics announced an FDA alignment that will let the company analyze its Phase 3 confirmatory trial of atacicept for IgA nephropathy in the third quarter, speeding the path to full approval ahead of the July 7 accelerated‑approval decision. The agreement eliminates...
ASCO26: In Vivo Oncology Approaches Continue to Show Promise
At ASCO 2026, in‑vivo CAR‑T approaches demonstrated strong early efficacy across blood and solid cancers. Eli Lilly’s partner Kelonia reported a 100% overall response rate in 18 multiple myeloma patients treated with KLN‑1010, bolstering Lilly’s pending $7 bn acquisition. Strand Therapeutics showed...
Kinase Droplets Activate Growth Signals, Path for Cancer Therapy
A MIT‑led study in Cell Reports shows that many kinases form liquid‑like condensates that concentrate ATP and substrates, dramatically increasing enzymatic activity. The researchers demonstrated this effect for focal adhesion kinase (FAK), Mst2 and Abl, finding that droplet formation can...
Ormoni Accelerates Peptide Drug Discovery to 30-Day Scale
Tirzepatide was the 7,023rd peptide in Lilly’s GLP-1 series. In its first year, Ormoni Biosciences synthesized and assayed more than 250,000 unique peptides. John Casey, Brad Pentelute, and the Ormoni team are bringing a step change to the development of new...
Coinbase CEO's NewLimit Secures 2nd Largest 2026 Biotech Round
NewLimit, the anti-aging startup co-founded by Coinbase CEO Brian Armstrong, has closed the 2nd largest round in biotech for 2026: https://t.co/NBjbMOH8bX
China's New Regulatory Data Protection Regime Becomes Effective Immediately
China’s National Medical Products Administration enacted the Implementation Measures for Regulatory Data Protection on May 15, 2026, creating a tiered data‑exclusivity system for pharmaceuticals. The regime grants up to six years of protection for innovative and imported originator drugs, four years for...
Fulcrum Mulls Sale After FDA Halts Sickle Cell Drug
Fulcrum exploring a potential sale after FDA sidelined its sickle cell drug https://t.co/NkFQ7vF6Ke by @realJacobBell $FULC - 52%
Biohybrid Microrobots Repair Spinal Cord by Combining Stem Cells with Magnetoelectric Nanoparticles
Researchers at ETH Zurich have created bio‑hybrid microrobots that pair neural progenitor stem cells with magnetoelectric nanoparticles, forming NPC‑bots that can be steered magnetically to spinal‑cord lesions. The nanoparticles translate external magnetic fields into localized electrical cues, accelerating stem‑cell differentiation...
Key Biosimilars Events of May 2026
May 2026 marked a surge in biosimilar activity, with approvals spanning Canada, the United States, the European Union, and South Korea for products targeting oncology, diabetes, immunology and ophthalmology. Notable launches include CuraTeQ’s Bevqolva (Avastin biosimilar) in Canada, Lannett’s Langlara (interchangeable...
ASCO: Pfizer Scores in Lung, Colorectal and Prostate Cancer but Key Readouts Still to Come
Pfizer entered ASCO 2026 fresh from a $10.5 billion partnership with China’s Innovent Biologics, using the deal to reinforce its oncology pipeline. The company unveiled more than 40 abstracts, including late‑breakers that showed an 81% reduction in disease‑progression risk for Lobrena in...